FDA Loosens its Leash on Medical Device Makers

//FDA Loosens its Leash on Medical Device Makers

FDA Loosens its Leash on Medical Device Makers

FDA logo 200The Food and Drug Administration (FDA) is making it a little easier on medical device manufacturers to “tweak” their product without having the burden of reapplying for permission to market.

Last week, the FDA announced it would not require manufacturers to alert the agency when changes are made to a device unless the change poses a safety risk. Who gets to decide that?  The manufacturer!

Historically, a medical device manufacturer had to create an FDA 806 report to signify if it planned to change a device and that change could represent a potential risk to health.

Under this new guidance, medical device changes that qualify as “enhancements” will not require an 806 report.

In fairness to device makers, they may want from time to time to “enhance” or improve their product. Maybe adding a blue stripe down the center of transvaginal mesh would make it more visible when a doctor is trying to remove the product.  A device may need to be improved to better measure the presence of antigens in the blood.  Steel used in a guide wire may need to be replaced with a better quality steel.

Generally speaking, these changes had initiated a recall, if the agency knew about it, but now manufacturers can bypass the 806 report if the “enhancement” doesn’t jeopardize safety.

Prolift mesh kit, Ethicon, J&J

Prolift mesh kit, Ethicon, J&J

Least Burdensome

Manufacturers are big on seeking out the “least burdensome” regulatory oversight. The 510(k) approval process is a prime example. Under 510(k) paperwork is exchanged so a manufacturer can market their device on the fast-track with no clinical trials required.

There is no doubt what’s least burdensome to industry has proven most burdensome to consumers who had no idea that the FDA was hands-off requiring assurances for safety and efficacy of devices under 510(k), and now under a lessened 806 requirement.

So this latest guidance is in line with the agency’s hands-off approach to device makers.

On November 5, the FDA will conduct a webinar with manufacturers to answer any questions.


It’s very “least burdensome” to avoid any scrutiny by the FDA and that is exactly what happened when Johnson & Johnson launched its Prolift vaginal mesh kit for the treatment of pelvic organ prolapse. Even though there had never been a large piece of mesh pre-cut complete with implanting devices prepackaged,  J&J just started selling the device.  It was only when, three years later, it asked the FDA to approve the Prolift +M did the FDA know anything about the original device.  There were no sanctions, no penalty and the agency simply approved both the Prolift and Prolift +M at the same time in 2008.

In handing over device regulation to the very companies it oversees, the FDA is expecting all to self-regulate  according to the rules.


Learn More:

FDA: Distinguishing Recalls from Medical Device Enhancement, October 15,  2014


Workshop November 5, 2014


FDA Least Burdensome Standard




By | 2014-10-21T23:42:20+00:00 October 21st, 2014|FDA News|13 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.


  1. msm October 22, 2014 at 7:23 am - Reply

    I believe the 806 guidance only requires reporting of the change by the maker to the FDA if the change is to reduce an existing risk to health or safety. If the maker believes that the “enhancement” or “improvement” is not being made to correct a safety issue but just to enhance the device, they do not need to report it to the FDA. Conversely, if the maker is changing a product to fix a problem that is in violation of FDA regulations, only then will the maker be required to report the change to the device.

    While the FDA issued guidance on how the maker should determine if the product was “violative” or “non-violative” in order to decide on reporting requirements, the manufacturer makes that call. If they decide that the change they are making is an improvement (i.e. changing a color to improve visibility) and not a fix (changing material in stimulator wires to reduce breakage), then they do not report the change. If a warning is added to a drug label, it may not need to be reported.

    An example more familiar to us: If a mesh manufacturer decides to increase the pore size of the mesh and justfies it internally as an enhancement or improvement, they are not required to submit a report. However, if the manufacturer admitted that the pore size was increased to reduce the likelihood of infection (a health risk), then a report must be submitted to the FDA. In the former, there would be not external paper trail that could be used as evidence in court if injuries occur from the device implanted prior to the “improvement”. No evidence that there was any change at all depending on the manufacturers internal documentation procedures.

    Papers get destroyed and email get deleted by “accident” conveniently when liability is in question. The fox is in charge of the hen house and the tail is wagging the dog. Device manufacturers fought for an autonomous and “less burdensome” process and the FDA bowed down and accomodated them. In my opinion, this “hand-off” approach by the FDA should be the focus of a congressional investigation BEFORE any injuries or deaths occur.

    Again, just my opnion.

    • Jane Akre October 22, 2014 at 11:47 am - Reply

      MSM- Your opinion is always valued…… you are very astute!

      • Jan Urban October 23, 2014 at 1:07 am - Reply


        • Jan Urban October 23, 2014 at 3:17 am - Reply

          I emailed Congressman Gibbs asking for an investigation of Mesh manufacturers and the FDA. I also faxed my request for assistance form off to Senator Brown, both are from Ohio. Can we do an on line request for an investigation by congress and the senate. One for each . after we get everyone to sign it make it available so we can forward it to each of are senators and congressman in our respective states, because they do not read out of state emails or letters. only correspondence from constituents. We have to stop these mad scientists once and for ALL!

  2. Jan Urban October 23, 2014 at 7:27 am - Reply

    I found a Wall Street article from January 2009 concerning the FDA and nine scientist at the FDA that said the FDA is a “Fundamentally Broken” agency. I find this to be very interesting and wonder if our medical devices were affected by the agencies practices. More then likely? The big push for Pelvic Mesh devices was in full swing during this period of time I would suspect. And, I as far as I know nothing was accomplished concerning any of the issues and problems these scientist at the agency brought forth. Go to: en.wikipedia.org/wikiFood_Drug_Administration Scroll down to References #72 to read article in the wall street journal. This could be in the meshnewsdesk archives but it is worth another look and our congressman and senators need reminding that the FDA in seriously Flawed and corrupt.

  3. All Meshed Up October 23, 2014 at 2:33 pm - Reply

    I’m naturally suspicious of the FDA and the Manufacturers. This decision, as is the 501(K) process, is an open ended proposition that the manufacturers can and will use to their profit. Any decisions that they may make that may go wrong can be blamed on the “decision” to allow them this ability to make certain changes without oversight. No one will be held accountable as is the Status Quo now. The FDA seems to be handing down decisions that distance THEMSELVES from decisions on crucial changes in medical devices while providing the manufacturers with more leeway to do as they please. What will stop the manufacturers from making design changes that they call improvements but we might call a new product? It really doesn’t make much difference because the FDA could care less about Guinea Pigs especially when they are human. At least the real guinea pigs get PETA behind them. We have…..uh……oh yeah, no one.

    • msm October 23, 2014 at 6:54 pm - Reply

      And when will the FDA find that a device manufacturer has gone beyond what is allowed without reporting? AFTER injuries and deaths come to light. How do they come to light? Not through MAUDE but through lawsuits. Only then does the FDA take a look at the MAUDE reports. It like shutting the stable door after the horse has bolted.

  4. Jan Urban October 23, 2014 at 7:01 pm - Reply

    In the MeshMedicalNewsDesks archives, dated Jun 14, 2012. FDA’s Tells Industry Medical Devices Reviews are Faster, More Efficient told this to a Life Science Industry group on June 11, 2012. What is down right unethical is what was said by Lawmakers in February 2012 regarding how much time is taken to review medical devices. In the article it said Members of the House Committee on Energy and Commerce criticized the agency for dragging their heels on device approvals. It was said that many on this committee advocate the interest of the medical device industry. UNETHICAL, and if you read the article I suggested in the Wall Street Journal with what nine Scientist reporting corruption, distortion of it scientific review process for medical devices. This was in Jan 2009. So, one might throw the towel in! With the latest news and it’s 806 requirements now lapse. The FDA’s query is over and has pretty much given the manufacturers carte blanche to do as they wish and like our mesh surgery, blindly pushing devices on the markets for commerce for our lawmakers. Dollar’s instead of People and Safety. Somehow we must keep talking, writing, calling and fighting to protect everyone from an Industry that maims and the government that protects this industry.

    • Jane Akre October 25, 2014 at 5:25 am - Reply

      The FDA is really our last defense against unethical predators and unfortunately its been MIA or promoting faster, more efficient medical device approvals. Which American is really behind that, unless they own a company that makes the med device? AdvaMed is the head cheerleader on faster med device approvals…. lobbying group out of Washington and very prominent at the FDA hearings on pelvic mesh in September 2011. ~ ja

  5. All Meshed Up October 24, 2014 at 10:52 am - Reply

    I would wait till after the November election before trying to talk to any Politicians. They are looking for money and votes not to help anyone. Any conversation now will be forgotten with the next handshake.

  6. msm October 24, 2014 at 2:59 pm - Reply

    The FDA has reorganized and increased manpower in it Center for Devices and Radiological Health (CDRH) section.It is devoted to monitoring advertising of devices to determine non-compliance .

    The Federal Trade Commission is already monitoring the advertisements for marketing compliance. It is the FTC’s duty to ensure that advertising of a product is true and does not make false claims (i.e. “clinically proven safe and effective”). Surely, the FTC must have a responsibility to inform the FDA’s CDRH of suspicions of a new product advertised without clearance.

    Instead of reviewing and actually investigating reports of injuries, adverse affects, and deaths related to medical devices, this branch is going to be skulking around the internet to see if they can catch a company red-handed.

    Now that really makes sense but in who’s world?

  7. Jan Urban October 25, 2014 at 12:25 pm - Reply

    I Emailed the President this morning and asked him why nothing was done regarding the request from 9 scientists at the FDA Medical Device unit pleading for restructuring of the agency back in 2009. This request was give to his transition team. Their main concern was with the agency’s scientific review process for medical devices having been “corrupted and distorted by FDA managers”. The White House also has a site for petitions: It allows you to set it all up on the site with clear instructions on how to do this. The sites address is: petitions.whitehouse.gov. There are several topics for a petition(s) that come to mind. Check it out. 150 signatures within the first month for the first stage, and then 100,000 for the second stage. There is no such thing as can’t. And waiting has only allowed the FDA and the manufacturers and of course lawmakers more room to do more harm. I also read a report today at Med City News.com October 24,2014 FDA improving medical device approval times, and also reputation-but only a little. It seems times are faster abroad and business is getting outsourced to Europe. We are getting pushed back once again. This is not good. Write the White House, Write your Congressman, Write your Senator and Write the Secretary of Health and Human Services requesting their assistance. They all have a hand in and up the manufacturer’s you no what. Call them on it. Keep writing everyday! There are plenty of facts to change it up, but make sure you are requesting their assistance in all correspondence.

  8. All Meshed Up October 27, 2014 at 10:41 am - Reply

    I am sure that President Obama will get back to you real soon. Maybe. Probably not. It is election season! They are only worried about their jobs and not people damaged by a Medical Device. And I will say this again( and again and again ) Nothing will happen until the FDA changes. Anyone who has questions about the safety of Medical Mesh will call or contact the FDA and ask them. They will be told we are just disgruntled patients who want to sue for no reason and just want more drugs. And THAT is the end of THAT. No one believes us other than other Mesh Victims. It does not matter to the FDA or any one else in this Government! They have a job and money and power and stature. That is what they are concerned about. If they were concerned about their citizens being lied to and damaged by a Medical device, something will have happened by now. As I look around, I do not see a thing being done on our behalf. When will we see a Politician stand up and be on our side? When his wife is implanted with mesh? Or maybe his son will get hernia mesh? I doubt it because they have money and influence and mesh is saved for the common folk. If this is not true then we would be seeing politicians, their family, Movie Stars and rich people with mesh implants. But we do not.

    I applaud all efforts to get the politicians to be on our side in this but the FDA has to be changed first. They are the “Go to people” when it comes to questions about Medical Device safety. Yes? Until they admit fault and start recalls we do not have a snowball chance in Hades. Until it becomes public knowledge that we have been lied to and experimented on, with the FDA’s full knowledge and cooperation, nothing will change.

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