+ Reply to Thread
Results 1 to 11 of 11

Thread: Social media being Trolled by FDA

  1. Link to Post #1
    Unsubscribed
    Join Date
    23rd June 2013
    Location
    North America
    Age
    67
    Posts
    6,884
    Thanks
    12,723
    Thanked 29,293 times in 6,140 posts

    Lightbulb Social media being Trolled by FDA

    Forums, facebook, all forms of social media are being trolled innocently at first and then more directly to get members to "reveal" that which is actionable by the FDA for instance.

    On InfoWars there is an interview - http://naturalsociety.com/video-fda-...histleblowers/ which is about 8 minutes 30 seconds long. It's worth a watch.

    If on social media for instance one is being asked about showing unregistered devices (a specific FDA terminology about that which has a medical use), or selling unregistered devices, or making devices which are known to be used "unregistered", the FDA has jurisdiction and can intercede.

    The official medical establishment is a very closed FOR-PROFIT system where those practicing medicine officially have to be licensed, regulated and jump through the approved hoops. Those deviating from the approved hoops, such as using "off label" techniques run the risk of fines and jail time, loosing their license to "practice". The word "practice" is key, one can never cure in the LICENSED system, on can only practice medicine, treat and use approved techniques and apparatus, or drugs, or devices.

    Here is the interview:


    There is a good discussion about the "system" being very determined to squash whistleblowers, or those who challenge the "establishment"..

    Quote From the interview:

    With activism at all time highs surrounding incognito threats lurking within the food supply, and major movements throughout the country all aimed at sweeping things like GMOs from the food supply, it should come as no surprise that agencies like the FDA are concerned about internal whistleblowers leaking key intel to the public.

    It should also come as no surprise that government organizations from the FDA to the FCC are now monitoring social networks across the board, all on a quest to track the flow of information that has now been dominated by the alternative news.

    I recently joined The Alex Jones show in studio to talk about how the alternative media, whistleblowers, and reasonable thinkers are causing some serious problems for corporate monopolies and government agencies alike

  2. Link to Post #2
    Unsubscribed
    Join Date
    23rd June 2013
    Location
    North America
    Age
    67
    Posts
    6,884
    Thanks
    12,723
    Thanked 29,293 times in 6,140 posts

    Default Re: Social media being Trolled by FDA

    From Med-Insider:

    Did you know the FDA recently issued a multi-million dollar contract to a private company that will be charged with monitoring social media?

    Yes, multi-million. Needless to say, that’s a significant amount of money.

    Although many would argue the FDA has not been very clear regarding its guidance towards social media, you can’t deny that the FDA is beginning to take social media more serious than it ever has.

    It's called: Social Media Best Practices for Marketing Medical Devices

    MP3 download of the interview here: http://traffic.libsyn.com/medsider/M...views_2013.mp3

    ref: http://medsider.com/interviews/socia...-mukesh-kumar/

  3. Link to Post #3
    Unsubscribed
    Join Date
    23rd June 2013
    Location
    North America
    Age
    67
    Posts
    6,884
    Thanks
    12,723
    Thanked 29,293 times in 6,140 posts

    Default Re: Social media being Trolled by FDA

    What for instance is the FDA position about advertising or making claims about a "device" or "apparatus" on Social media (remember the words apparatus and device have a very specific understanding in the eyes of the FDA)

    FDA’s current policy--social media promotion is the same as traditional advertising for purposes of regulation, i.e.,
    • Any reference to the product and attribute must include in the message
    comprehensive information about the product’s risks
    • Express and implied claims cannot be false or misleading
    • Implied claims are created through use of graphics, music, color, themes
    • FDA looks at the net impression created by the promotion
    Can a manufacturer of a device or apparatus say "First Amendment Rights Protect"

    No, the courts have said, Product Advertising and Promotion is commercial speech— it does not receive the highest level of First Amendment constitutional protection but has some protection.

    ref: https://www.morganlewis.com/~/media/...a_14nov13.ashx

  4. Link to Post #4
    Unsubscribed
    Join Date
    23rd June 2013
    Location
    North America
    Age
    67
    Posts
    6,884
    Thanks
    12,723
    Thanked 29,293 times in 6,140 posts

    Default Re: Social media being Trolled by FDA

    Trolls may be trained government agents according to leaked document - they start by feigning some "condition" some "situation" some "disease" and they ask for help. Of course that tugs on one's heart strings and good minded and good caring people are all too eager to offer help. But there may be a dark side, one may be being trolled for a sinister purpose.
    Glenn Greenwald, a journalist, constitutional lawyer, commentator, and author of three New York Times best-selling books on politics and law, has been working with NBC News in publishing a series of articles on how covert government agents infiltrate the Internet to “manipulate, deceive, and destroy reputations.”

    The information is based on documents leaked by National Security Agency (NSA) whistleblower Edward Snowden. Greenwald’s article, How Covert Agents Infiltrate the Internet to Manipulate, Deceive, and Destroy Reputations, is based on four classified documents produced by the British spy agency GCHQ, and presented to the NSA and three other English speaking agencies reportedly part of “The Five Eyes Alliance.”

    In this shocking piece, Greenwald publishes a copy of a spy training manual used entitled: “The Art of Deception: Training for Online Covert Operations.” Greenwald writes that agencies like the NSA are “attempting to control, infiltrate, manipulate, and warp online discourse, and in doing so, are compromising the integrity of the internet itself.” Greenwald writes:

    Among the core self-identified purposes of JTRIG are two tactics: (1) to inject all sorts of false material onto the internet in order to destroy the reputation of its targets; and (2) to use social sciences and other techniques to manipulate online discourse and activism to generate outcomes it considers desirable. To see how extremist these programs are, just consider the tactics they boast of using to achieve those ends: “false flag operations” (posting material to the internet and falsely attributing it to someone else), fake victim blog posts (pretending to be a victim of the individual whose reputation they want to destroy), and posting “negative information” on various forums.

    While this kind of counter-intelligence activity may not sound surprising given the objectives of spy agencies going after terrorists, what disturbs Greenwald (and many others) is that the discussion regarding these techniques have been greatly expanded to include the general public:

    Critically, the “targets” for this deceit and reputation-destruction extend far beyond the customary roster of normal spycraft: hostile nations and their leaders, military agencies, and intelligence services. In fact, the discussion of many of these techniques occurs in the context of using them in lieu of “traditional law enforcement” against people suspected (but not charged or convicted) of ordinary crimes or, more broadly still, “hacktivism”, meaning those who use online protest activity for political ends.

    The title page of one of these documents reflects the agency’s own awareness that it is “pushing the boundaries” by using “cyber offensive” techniques against people who have nothing to do with terrorism or national security threats, and indeed, centrally involves law enforcement agents who investigate ordinary crimes.

    No matter your views on Anonymous, “hacktivists” or garden-variety criminals, it is not difficult to see how dangerous it is to have secret government agencies being able to target any individuals they want – who have never been charged with, let alone convicted of, any crimes – with these sorts of online, deception-based tactics of reputation destruction and disruption.

    And while these leaked documents concern the British spy agency, Greenwald is quick to point out that the Obama administration has actually been open and forward about using such techniques in the U.S.:

    Government plans to monitor and influence internet communications, and covertly infiltrate online communities in order to sow dissension and disseminate false information, have long been the source of speculation. Harvard Law Professor Cass Sunstein, a close Obama adviser and the White House’s former head of the Office of Information and Regulatory Affairs, wrote a controversial paper in 2008 proposing that the US government employ teams of covert agents and pseudo-”independent” advocates to “cognitively infiltrate” online groups and websites, as well as other activist groups.

    Sunstein also proposed sending covert agents into “chat rooms, online social networks, or even real-space groups” which spread what he views as false and damaging “conspiracy theories” about the government. Ironically, the very same Sunstein was recently named by Obama to serve as a member of the NSA review panel created by the White House, one that – while disputing key NSA claims – proceeded to propose many cosmetic reforms to the agency’s powers (most of which were ignored by the President who appointed them).
    ref: https://healthimpactnews.com/2014/in...aked-document/
    Last edited by Bob; 6th November 2018 at 20:55.

  5. Link to Post #5
    Avalon Member avid's Avatar
    Join Date
    19th March 2010
    Location
    NW UK
    Posts
    2,241
    Thanks
    28,851
    Thanked 9,510 times in 2,011 posts

    Default Re: Social media being Trolled by FDA

    OMG - this is so sick, so divisive, it makes one distrust everything. How horrendous is that?
    The love you withhold is the pain that you carry
    and er..
    "Chariots of the Globs" (apols to Fat Freddy's Cat)

  6. The Following 7 Users Say Thank You to avid For This Post:

    angelfire (6th November 2018), Bassplayer1 (7th November 2018), Bill Ryan (6th November 2018), Bob (6th November 2018), Nasu (7th November 2018), Sadieblue (7th November 2018), toppy (7th November 2018)

  7. Link to Post #6
    Unsubscribed
    Join Date
    23rd June 2013
    Location
    North America
    Age
    67
    Posts
    6,884
    Thanks
    12,723
    Thanked 29,293 times in 6,140 posts

    Default Re: Social media being Trolled by FDA

    Most certainly Avid, one has to be aware when one is asked certain things.. Is one being trolled, is there some hidden reason? Who get's the data, are we being surveyed for our opinions, or our "beliefs" - what is the trend the scuttlebutt happening which those pulling the strings need to understand better (so that they can refine their control methods)..

  8. Link to Post #7
    Unsubscribed
    Join Date
    23rd June 2013
    Location
    North America
    Age
    67
    Posts
    6,884
    Thanks
    12,723
    Thanked 29,293 times in 6,140 posts

    Default Re: Social media being Trolled by FDA

    I highly recommend reviewing Bill's thread here to get a good critical view of how to look at what is happening around one objectively - http://projectavalon.net/forum4/show...=1#post1258413

    It's a good read and VERY much so ON-TOPIC..
    Last edited by Bob; 6th November 2018 at 21:23.

  9. Link to Post #8
    Unsubscribed
    Join Date
    23rd June 2013
    Location
    North America
    Age
    67
    Posts
    6,884
    Thanks
    12,723
    Thanked 29,293 times in 6,140 posts

    Default Re: Social media being Trolled by FDA

    We all know those fellows going by the company name "Monsanto" - (please see Herve's threads which have eloquently exposed Monsanto's most awful harming of humanity)..

    FDA - FOOD and drug Administration - MONSANTO modifies FOODs making a food in essence a "drug" to go alter how the food is processed in the body. That is a very accurate technical statement, the addition of a bacteria gene which gut busts insects that consume such, can also gut bust humans and other animals.

    See this article:

    Monsanto and Others Caught Paying Internet ‘Trolls’ to Attack Activists

    Definition: an internet troll is:

    “…a person who sows discord on the Internet by starting arguments or upsetting people, by posting inflammatory, extraneous, or off-topic messages in an online community (such as a newsgroup, forum, chat room, or blog) with the deliberate intent of provoking readers into an emotional response or of otherwise disrupting normal on-topic discussion.“

    Does this sound like some posts you’ve seen before? Now, let’s be clear: there are tons of internet trolls out there that are absolutely not on the pay roll. Most of these people are genuinely just messing with others to get a laugh, a reaction, or whatever. Not arguing on behalf of multi-billion dollar corporations for up to 8 hours per day.

    There’s the real difference. And, besides common sense dictating that corporations would surely hire a fleet of internet warriors to protect their brand reputation in the age of open source online communication, we now know for sure that companies like Monsanto have in fact dedicated ‘entire departments’ to trolling scientists and ‘discrediting’ those who oppose their GMO creations.

    Monsanto Paying Fleet of Trolls to ‘Discredit’
    Surprisingly, it was actually a Monsanto employee that unintentionally let the truth behind their ‘discrediting operation’ slip in a conference with students that he may have forgotten was open to the public. In a conversation with students, Dr. William “Bill” Moar raved that Monsanto had established:

    “An entire department” (waving his arm for emphasis) dedicated to “debunking” science which disagreed with theirs.”

    That’s huge news. We told you about this first back on the 6th of April — but I am absolutely shocked how it has not been covered to the extent it should have. Because, after all, how does a company ‘discredit’ and ‘debunk’ those who go against their destructive, cancer-linked products? By attacking them online through blogs, comments, and character assassination. In other words, by internet trolling.

    It’s so much easier to say someone is a ‘quack,’ or create some fictitious and anonymous accusation to plague their search data than it is to actually have a scientific debate on issues like Roundup’s admitted probable carcinogenic nature.

    It also brings into question whether or not the Monsanto employee truly did ‘slip up’ or if he was attempting to help get the word out about the corporation he represents. You have to wonder if Dr. Moar was secretly passing off some information to the press in the form of a slip about his company.

    This is a question I often wondered after hearing about Coca-Cola’s similar operations that extended deeper than just internet trolls. After reading the March 16th article in the Associated Press that broke down how Coca-Cola paid off health leaders in exchange for these ‘experts’ to back their chemical-laden sodas as health drinks.

    The AP report reads:

    “In February, several of the experts wrote online posts for American Heart Month, with each including a mini-can of Coke or soda as a snack idea. The pieces — which appeared on nutrition blogs and other sites including those of major newspapers — offer a window into the many ways food companies work behind the scenes to cast their products in a positive light, often with the help of third parties who are seen as trusted authorities.”

    A mini-can of Coke as a ‘snack idea.’ What amazing health leaders these individuals truly are.

    Next time you’re scrolling through social media, YouTube, or even this website’s comment section, remember that the trolls attacking you for no apparent reason may in fact be receiving an annual salary.
    ref: http://naturalsociety.com/monsanto-a...ack-activists/
    Last edited by Hervé; 7th November 2018 at 01:15. Reason: Added link

  10. Link to Post #9
    UK Avalon Founder Bill Ryan's Avatar
    Join Date
    7th February 2010
    Location
    Ecuador
    Posts
    21,757
    Thanks
    76,907
    Thanked 273,583 times in 20,231 posts

    Default Re: Social media being Trolled by FDA

    Quote Posted by Bob (here)
    In this shocking piece, Greenwald publishes a copy of a spy training manual used entitled:

    The Art of Deception: Training for Online Covert Operations.
    Here it is:

    Last edited by Bill Ryan; 6th November 2018 at 21:26.

  11. The Following 10 Users Say Thank You to Bill Ryan For This Post:

    angelfire (6th November 2018), avid (6th November 2018), Bassplayer1 (7th November 2018), Bob (6th November 2018), Hervé (6th November 2018), Innocent Warrior (8th November 2018), Nasu (7th November 2018), norman (6th November 2018), Sadieblue (7th November 2018), Sophocles (6th November 2018)

  12. Link to Post #10
    Unsubscribed
    Join Date
    23rd June 2013
    Location
    North America
    Age
    67
    Posts
    6,884
    Thanks
    12,723
    Thanked 29,293 times in 6,140 posts

    Default Re: Social media being Trolled by FDA

    What does the FDA say about their right to "regulate" "control" and obtain information needed for them to "do their job"?

    https://www.fda.gov/Training/CDRHLearn/ucm281656.htm

    the title of the article from the above link is this:

    Overview of Regulatory Requirements: Medical Devices - Transcript

    here it is: (notice how clear and easy it is to read and understand (satire..) and how one wanting to just "build something" may miss all the details and fall into the traps...

    I've added some "white space" and underlined a few keys so that the reader can follow along a bit easier. It is never-the-less deep.

    I've commented using brackets " { } " where some dialog may be helpful.. It is interesting seeing the bureaucratic mindset in operation tho..

    ===============================
    Hello. My name is Bill Sutton, and I am Deputy Director of the Division of Industry and Consumer Education (DICE) and FDA's Center for Devices and Radiological Health.

    Welcome to CDRH Learn, FDA's web page for industry education. CDRH Learn is our latest innovative educational tool. It consists of a series of training modules describing many aspects of medical device and radiological health regulation, covering both pre-market and post-market issues. This tool is intended to provide the medical device and the radiological health industry with an information resource that is comprehensive, interactive, and easily accessible. This module is intended to provide an overview of the regulatory requirements for medical devices or what is sometimes referred to as Devices 101.

    The US Food and Drug Administration (FDA) is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccine, biological medical products, blood products, medical devices, radiation-emitting products, veterinary products, and cosmetics. Within FDA, the Center for Devices and Radiological Health (CDRH) is responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary exposure to radiation-emitting products. {LASERS or LED's also described as PHOTONICs are regulated then by the FDA when they can expose either deliberately or accidentally a living organism.. That is humans, plants, animals }

    Now, let's take a closer look at the organization chart for the Center for Devices and Radiological Health. At the top of the organization chart is the Office of the Center Director and includes the CDRH Ombudsman, followed by seven offices. Each office serves a function that collectively ensures that all medical devices placed on the market in the United States are deemed reasonably safe and effective throughout the total product life cycle.

    Let's begin by looking at the Office of Compliance. This is the office responsible for ensuring that all medical devices, once placed on the market, remain safe and effective. This is the office that reviews the establishment inspection reports and recalls.

    The next office, the Office of Communication, Education, and Radiation Programs, is the office that's responsible for the education of the staff, through our Staff College. This is where our Radiation Program is administered. This is where the Industry Assistant's Office is located, as well as the television studio where I'm taping this program today.

    The next office, the Office of Device Evaluation, is responsible for all the pre-market reviews of applications, the pre-market notifications 510(k)s, the pre-market approval PMAs, as well as the investigational device exemptions. { if one has defined one's apparatus as "investigational device status" and adheres to the rules behind "investigational devices" one can get one's product to the researcher. One is not generally then marketing to the PUBLIC, but to qualified researchers willing to report their results back to the developer }

    The next office, the Office of In Vitro Diagnostic Device Evaluation and Safety, is the office that reviews all the pre-market applications for in vitro diagnostics, as well as all the post-marketing activities associated with in vitro diagnostics. The next office, the Office of Management Operations, is the office that is responsible for our building, our budget, general administrative requirements at the Center for Devices and Radiological Health.

    Next, the Office of Science and Engineering Laboratories is where our Center's laboratories are located.

    They do independent lab testing, work with standards organizations, universities, and other academia.

    Next, the Office of Surveillance and Biometrics is the office that's responsible for the post-marketing activities or adverse event reports with regard to medical devices. { we all did catch that, right "office of Surveillance" - let's pull up a definition of that Collins Dictionary - "Surveillance is the careful watching of someone, especially by an organization such as the police or the army." }

    "Who We Are" –

    The Center for Devices and Radiological Health is a team of dedicated and highly skilled employees with a variety of backgrounds. Many are scientists, biologists, chemists.

    This slide provides an example of the type of backgrounds that are working collectively to review these medical devices.

    The CDRH mission is to assure that all medical devices, once placed on the market, are reasonably safe and effective. { the keyword is effective, any bogus "device" is considered non-effective and possibly even harmful - the FDA will intercede in those situations }

    We do this by looking at the benefit/risk, when we review these medical device applications. Once a device has been found reasonably safe and effective, our job is to ensure that once they are placed on the market, they remain safe and effective.

    And finally, we get this information to our stakeholders through our web site and through electronic notifications on how we make these determinations of safety and effectiveness.

    Let's look at the definition of a medical device.

    It can be found in Section 201(h) of the Federal Food, Drug, and Cosmetic Act. It's a very broad definition.

    It basically says a medical device is “any instrument, machine, contrivance, implant, in vitro reagent that's intended to treat, cure, prevent, mitigate, diagnose disease in man”.

    Some examples could be a simple tongue depressor, or a thermometer, all the way to an advanced robotic surgical device.

    The definition also goes on to say that a medical device does not achieve its primary intended use through a chemical activation on or within the skin, and it's not required to be metabolized to achieve that primary intended use. If it's one of those two, the FDA would regulate that product as a drug.

    This slide gives some examples of the products we regulate at the Center for Devices and Radiological Health: anything from MRI equipment, to stethoscopes, adhesive bandages, and latex gloves.

    FDA was given the authority to begin regulating all medical devices on May 28, 1976.

    This is when the President signed the Medical Device Amendments Act. FDA interprets the law that was written. We write proposed rules. We put those proposed rules in the Federal Register. Think of the Federal Register as the US government's daily newspaper. We ask for comments. We consider those comments.

    We then write a final rule. That final rule is posted in the Federal Register. Once those rules go final, they're placed in the Code of Federal Regulations, Title 21, Parts 800-1299.

    So, I always like to say that it's the medical device amendments that give FDA authority to regulate medical devices. It's the regulations in 21CFR, Parts 800-1299, that give FDA and industry guidance on how to comply with the provisions of the Act.

    This slide describes the device classification. FDA has classified all medical devices into either Class I, II, and III. Currently, in the Code of Federal Regulations, there are about 1700 devices that have been classified by the FDA. They can be found in 16 medical specialties or device panels.

    Here's an example: Anything that begins with Part 870 is a cardiovascular device. Anything that begins with Part 880 is general hospital, and so on.

    Here's an example of a regulation and how product codes play a part in the regulation classification of a medical device: If you were to look under Part 880.5780, you would see a short identification for a medical support stocking.

    Now, look closely at the identification.

    A medical support stocking that is intended to prevent the pooling of blood in the leg is a Class II medical device and requires a pre-market notification. FDA will assign a distinct product code, DWL, for these types of devices. { socks in other words that help one's legs from getting DVT's - deep vein thrombosis for instance }

    If you are intending to label that medical support stocking for general medical purposes, it's now Class I, and it's exempt from pre-market notification 510(k). The product code FLL is unique for the Class I exempt medical support stockings.

    So it’s very important to look online at our product classification database. Look at those regulation numbers. Look at those product codes to ensure that you have identified the most appropriate regulation product code for your device. I said earlier that FDA has classified about 1700 device types. Let's look at how these are broken out by class.

    Class I devices are the low-risk devices.

    There are about 780 of those. They require general controls, and I'll talk about those general controls next.

    Class II devices require general controls and special controls.

    There are about 800 Class II medical devices. These are our medium to moderate risk devices.

    Finally, Class III require general controls and pre-market approval, PMA.

    Those are the lower number of classified devices, about 120; however, these are high risk, generally life-supporting, life-sustaining devices.

    So, let's look at those general controls that apply to all classes of devices,

    Class I, Class II, Class III.

    The law is very clear in that no medical device shall be adulterated or misbranded.

    { You can't change it's intended use, by adding something to it's legal registered use or using it in a way which is different than what the label says it is to be used for and HOW... this is where a practitioner can get in a LOT of trouble, using a drug or device in a different way than the FDA filing says it must be used..}

    Those are the two violations that the Office of Compliance will issue a letter for to medical device firms. An example of adulteration would be manufacturing a device that is not in compliance with our quality system regulation, our current good manufacturing practices. Adulteration could be placing a device on the market that requires a marketing application such as a 510(k), but the firm failed to get that 510(k) clearance.

    Misbranding, that could be putting an intended use on a device labeling that FDA did not clear that device for. It could also be selling a device over the counter that requires a prescription labeling. That's misbranding, and that's prohibited under the federal Food, Drug and Cosmetic Act.

    Next, electronic establishment registration.

    I'll talk more about that. This is a requirement for all finished device manufacturers, as well as importers of medical devices. Manufacturers must also list their medical devices with the FDA at the time they plan to market their device.

    General controls may be a pre-market notification or 510(k), and I'll talk more about the 510(k) program. General controls require that all finished device manufacturers comply with our quality system regulations, our current good manufacturing practices. General controls require that all medical devices be properly labeled.

    Also, general controls require that all manufacturers, user facilities, and importers report when there's been an adverse event with a medical device. This is known as our Medical Device Reporting program or MDR.

    Now, let's look at those special controls for those Class II medical devices. A special control could be a guideline.

    Here's an example of a glove manual: This glove manual will give the manufacturers specific information about how to prepare a 510(k) application for a medical glove.

    A special control could be a mandatory performance standard. Today, FDA has only written one mandatory performance standard, and that's for patient cables and electro lead wires. However, the FDA has been able to recognize over 800 voluntary standards. These could be other recommendations or actions.

    { A glove that heals a hand which has been close to frost-bite would be a FDA regulated item !! }

    A special control could be special labeling. Here's an example (on this slide) for special labeling for a cranial orthosis. There's special labeling for IVDs, for hearing aids, for condoms. So, very important to look to see are there special labeling requirements for your medical device?

    And, finally, a special control could be a guidance document.

    FDA has written many guidance documents, not a guidance for every medical device application.

    The FDA Good Guidance Practices Database provides a listing of all those guidance documents, and FDA encourages you, the manufacturer, to look for those guidance documents to assure that you're going to meet the requirements that we would expect to see in those medical device applications. { every manufacturer of a medical device falls under FDA jurisdiction and the FDA can inspect one's place of business or manufacturing facility, and that place MUST adhere to the "good Guidance Practices, or be shut down and or fined, items confiscated and jail time for the violators }

    I talked earlier about a general control being Establishment Registration and Medical Device Listing. This is a good point to make, that FDA requires the finished device manufacturers to be the ones that register to list and submit those medical device applications. This is done now electronically. It's done after the manufacturer has received their 510(k) or PMA clearance, or at least within 30 days of going to market with their medical device.

    And yes, firms outside the United States must also register and list, as well as name a US agent for that foreign establishment.

    The US agent must reside in the United States, must be familiar with the operations of that foreign establishment, and FDA may contact that US agent if we need to get information to the foreign manufacturer. At the same time a manufacturer registers their establishment, they also want to list their medical devices. This let’s FDA know where the medical device is being manufactured and what type of device is being manufactured, so that that manufacturer can be found for an inspection later by the FDA field offices.

    Annual registration is done every October through December for the upcoming calendar year.

    Another general control that I talked about is the pre-market notification or 510(k) program. I only have a couple of slides to talk about the 510(k) program. This is a general overview. This is something that we could talk probably a couple of days about, but it's important to know that a 510(k) is a marketing clearance process. It is not an approval; again, it’s a marketing clearance process. There is no form. However, there is a format on content and format. There's guidance online that will assist the applicant on preparing that 510(k) application. { the FDA does not recommend or attest to any device's efficacy, it allows for registration that the manufacture must PROVE so and such works is safe and effective in the claims made. The FDA looks at those claims and verifies that the apparatus and/or device meets those claims, to hear the term FDA approved is a misnomer in other words }

    The 510(k) must be submitted at least 90 days prior to market.

    The purpose of a 510(k) is to demonstrate that one device is substantially equivalent to another legally-marketed device. This could be a device that was on the market prior to 1976 or has since been found equivalent through the 510(k) program.

    So, what does substantially equivalent mean?

    It means it's just as safe and it's just as effective as the predicate device. Again, not an approval; it's a clearance, and FDA is determining Substantial Equivalence.

    So, when is a 510(k) required?

    When an applicant is planning to introduce a device on the market for the first time under their name or if they made significant modifications to their currently marketed device and those modifications may have significant effects to safety and effectiveness that would require a new 510(k). The good news is that we do have a guidance document on helping manufacturers determine when a modification may or may not require a new 510(k). Now, some medical devices are exempt from 510(k), so general controls is a 510(k) unless exempted by statute.

    In 1997, through the passage of the FDA and Modernization Act,

    Congress authorized the FDA to exempt all Class I medical devices, remember, those low-risk medical devices. FDA was not comfortable with exempting all Class I devices, and there are still about 50 device types that require a 510(k). We refer to those as Reserve Devices, but there are about 93% of those Class I devices that are exempt, or about 730 devices.

    Congress also gave FDA authority to begin regulating some Class II medical devices. There's about 9% or 70 of those Class II devices that are exempt from 510(k).

    You don't have to guess if you're exempt. Again, the regulation in the Code of Federal Regulations will identify or state whether the device requires a 510(k) or if it's exempt from 510(k).

    We do have a Third Party Program that was mandated through the passage of the 1997 FDA and Modernization Act. We currently have third parties both in the United States and outside the United States that can review 510(k)s on our behalf. They make recommendations and submit those recommendations and the 510(k) to the FDA for review. This is also known as our Accredited Persons program.

    The special 510(k) –

    I talked earlier about making modifications to a legally cleared device.

    If an applicant needs to make or makes modifications that require a new 510(k), they may be eligible for a special 510(k) by submitting a Conformance to Design Controls, which is a part of our quality system regulation. FDA agrees that it meets the criteria for a special 510(k). We're committed to reviewing that within 30 days.

    And, finally, the abbreviated 510(k) is where the applicant is complying to a recognized standard, a guidance document; and, hopefully, with the reduced data that's going to be provided in that 510(k) and by the reviewer just primarily looking at the summary of that data, we may be able to review those devices quicker than 90 days.

    There is a 510(k) device user fee.

    This began in the year 2002. There will be a standard fee for the 510(k), as well as a small-business fee for that 510(k), and the small business fee would be looking at the applicant, including the applicant, if they have a parent firm, if they have affiliates, that their combined gross receipts and sales for the most recent tax year were 100 million or less. They can apply for that small business fee, which may reduce that fee by 50%.

    Now, let's look at the Pre-Market Approval Program, or PMA.

    The pre-market approval is an application required for the high-risk medical devices, those Class III medical devices I referred to earlier. A PMA is going to be required if the regulation or classification in the Code of Federal Regulations require the PMA. It could also be for a device that there is no equivalency. It's not substantially equivalent to any other device like that on the market. In other words, it's new. There's no basis for substantially equivalent. This could be because there is no predicate device labeled with the same intended use on the market, FDA's never seen that device before, or it could be that the predicate was not cleared for those intended uses.

    And, again, we at the FDA have not seen that type of device before, or it could be that technology associated with that device raises new questions of safety and effectiveness that may require a PMA or pre-market approval application.

    And the purpose of the PMA is to show the FDA or to demonstrate to the FDA that through valid scientific evidence, the device is reasonably safe and effective on its own. So, where the 510(k) is really a comparison or a "me too" to the predicate device, the PMA device is standing on its own, and that's primarily done through a lot of clinical studies.

    Now, there is a PMA device user fee for that device review by the FDA.

    Just like the 510(k), there's a standard fee, as well as a small-business fee.

    The good news is that for that PMA device, if it's the very first PMA application for that applicant and the applicant is able to demonstrate that their most recent gross receipts and sales for the most recent tax year were 30 million or less, FDA is going to waive that fee. If it's 100 million or less, there will be a reduced fee.

    Now, so far, I've talked about the two types of marketing applications at the FDA: the pre-market notification 510(k), as well as the pre-market approval or PMA. FDA is also responsible for the review of all unapproved device studies, the devices and the studies themselves that are going to be used on human subjects in the United States.

    So, what does that exempt the applicant from? They don't submit marketing applications. They don't register/enlist with the FDA. There are a few other exemptions, as well, but again, these are regulations for unapproved medical devices.

    The way that FDA looks at unapproved medical devices is we put them into one of two categories: significant-risk devices or non-significant-risk devices. Think of those significant-risk devices as those high-risk Class III devices, life-supporting, life-sustaining devices.

    Before the applicant or sponsor of that study can begin that study, they must obtain IDE approval from the FDA first. { ide: "investigational device exemption" }



    However, if it's deemed to be a non-significant-risk device, FDA does not need to approve that study, but what FDA does require is what we refer to as the abbreviated IDE program.

    That's going to require institutional review board oversight, so basically the IRB will serve as the surrogate FDA and have oversight of that study, and also there must be informed consent.

    So, the subjects participating in that study must know that this is an unapproved medical device. They must be made aware of the benefits, as well as the risk in participating in this study.

    The IDE program is intended, again, to be used on human subjects, to collect safety and effectiveness data, and most importantly, they are intended to protect those human subjects in the study.

    I spoke earlier about the general controls.

    That includes medical device labeling. What I'd like to say about this slide is that labeling is really anything associated with that device.

    It can be the labeling that's on the device.

    It can be instructions for use, advertising and promotional material.

    It's all labeling, and FDA would like to see all of that in the marketing application.

    Labeling must provide adequate directions for use, unless it's exempt, and what that refers to is our prescription requirements for devices.

    Most medical devices placed on the market are prescription devices.

    What that means is they can only be sold to or on the order of a physician, and labeling must not be false or misleading.

    If it is, it's misbranding; and as I talked about earlier, that is a violation of the Federal Food, Drug and Cosmetic Act.

    The Quality System Regulation or current good manufacturing practices is a good quality assurance program that the manufacturers must follow when marketing that device.

    What that does is it gives FDA assurance that once FDA has cleared that device for market, that it's going to be manufactured consistently, according to the specifications for which FDA granted marketing clearance or approval. It's very similar to the International Standard 13485, and it's the standard for which we audit and spec medical device manufacturers against.

    Next, Medical Device Reporting, or MDR, is a general control.

    This is our adverse event reporting program. It's a mechanism that FDA has in place for identifying, monitoring, and capturing adverse events involving medical devices. This is when a medical device may have caused or contributed to a serious injury, death, or if a malfunction was to reoccur, may cause or contribute to a serious injury or death. That must be reported to the FDA. Who needs to make those reports? Manufacturers, user facilities, and importers of medical devices.

    Let's now take a look at post-market studies.

    Post-market studies are a means by which FDA can collect safety and/or effectiveness data for a 510(k) cleared or PMA-approved device.

    The first type of post-market study is a post-approval study.

    A post-approval study is a study that is required as a condition of approval for a PMA. A PMA may actually have more than one post-approval study and may include both clinical and non-clinical studies. In general, a post-approval study is a clinical study intended to collect long-term safety and/or effectiveness data for the approved device or to collect data that shows the device's safety and/or effectiveness in a real-world setting.

    Now, Section 522 Post-market Surveillance Studies, on the other hand, are studies that are mandated by FDA any time after a 510(k) is cleared or a PMA is approved. The criteria for a 522 study are a Class II or Class III device are –

    One: for which failure of the device would be reasonably likely to have a serious adverse health consequence;
    Two: it's expected to have significant use in pediatric populations;
    Three: it's intended to be implanted in the body for more than 1 year; or
    Four: it's intended to be a life-supporting device used outside of the user facility.

    Section 522 studies are typically designed to address specific questions.

    After completion of a post-approval study or a Section 522 Post-market Surveillance Study, the labeling for the device is updated to reflect the findings.

    Now let's look at medical device tracking, another post-marketing tool the FDA has in place to ensure the device remains safe and effective once granted marketing clearance or approval.

    Much like the post-market or post-market surveillance devices, medical device tracking devices are either going to be Class II or Class III-- again, the failure of which would reasonably have a serious public adverse health consequence--is implanted in the body for more than 1 year, or is life-sustaining, life-supporting, used outside of the device user facility, a hospital.

    Here's a couple of examples: a replacement heart valve, mechanical, or a ventilator used in the person's home is a tracked device.

    And the purpose of a tracked device, again, is for the manufacturers to know exactly to the end user who has that device, so that if they become aware of a problem that needs to be corrected quickly with these high-risk devices, that they can get that notification to the end user as quickly as possible.

    I've gone through many of the regulatory requirements for medical devices.

    This slide is intended to provide a reference for where the viewer can look for more information on these various programs. I encourage you to look at the Code of Federal Regulations online for these references to get more information.

    Now, I have covered a lot of information here.

    It was a general overview of our device regulations. The good news is there is a mandated division where you can go and get assistance 5 days a week, Monday through Friday, 8 to 5, and that is known as the Division of Industry and Consumer Education (DICE). We help everybody. This slide provides our e-mail address. We have a toll-free number. We have a fax number.

    As I said earlier, there are medical device specialists from 8 to 5 to help answer your questions.

    We're going to cover and help assist you with any questions you have from pre-market to post-market, importing/exporting medical devices. Again, I encourage you to e-mail us. I encourage you to call our office if you have any questions regarding any of the information that I covered during this module. And with that said, I want to thank you for watching. There's our Web site.

    I hope you found this module informative and helpful, and it's given you a better broad overview of how the FDA regulates medical devices. I encourage you to look at the other modules online at CDRH Learn to learn more information and go into more depth about the information that I've covered today.

    I thank you for watching, and have a good day.
    ===============================

    Now wasn't that easy to follow along and now that you understand how to work with the FDA aren't you eager to just talk about your building of medical devices and apparatus to help mankind? (satire)
    Last edited by Bob; 7th November 2018 at 02:34.

  13. Link to Post #11
    Canada Avalon Member Bassplayer1's Avatar
    Join Date
    25th December 2012
    Posts
    106
    Thanks
    1,995
    Thanked 738 times in 93 posts

    Default Re: Social media being Trolled by FDA

    Thank you for this post Bob and everyone else for your contributions. This is awful!!! I had a look through 'The Art of Deception Training' PDF and although I don't understand much of the jargon, I DO understand deep down, even if I can't put it into words. And its horrifying!! My only words of comfort here are, when in doubt, take a deep breath and one chopped clove of garlic with water before bed. Yes, I'm being a bit flippant against this disturbing situation … but actually I'm not. It's getting to the point where something as simple as this, is very powerful actually, and one of the very few things I trust as a constant in my daily life. When I feel we're being assaulted with toxins and lies from all sides by the system I remind myself of this - one of the most invaluable videos I've ever watched. I hope I'm not distracting from the topic, its just a simple mother nature daily habit that comforts and grounds me from all this onslaught https://www.youtube.com/watch?v=pZC_jlfY81A The FDA can eff off!!!

  14. The Following 4 Users Say Thank You to Bassplayer1 For This Post:

    avid (7th November 2018), Bill Ryan (7th November 2018), Bob (7th November 2018), Innocent Warrior (8th November 2018)

+ Reply to Thread

Tags for this Thread

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts