On January 3, 2012, the FDA sent out copies of a 522 order to 33 manufacturers of synthetic surgical mesh for pelvic organ prolapse and 7 manufacturers of mesh for stress urinary incontinence.
Here is the background story on MDND.
The request says, “Within 30 days of receipt of this order, you must submit your plan to conduct postmarket surveillance of your device to the address listed below. Your submission should clearly identify it as a postmarket surveillance plan and include the PS number referenced above.”
Since more than 30 days have passed – where on the FDA site do I see the plans submitted?
The FDA has set up a separate page (here) for 522 requests and results.
But none of the studies appear on the site. Some requests for 522 postmarket studies go back to 2009, and also do not appear.
A 522 study (here) can be requested by the FDA if a device made it on the market and there are some doubts about its safety. It is not a recall but a request for information AFTER it’s on the market, not before. Since 90 percent of medical devices make it to the market with no data required, this is considered an important tool, short of revamping the entire medical device division of the FDA and making it more like the scrutiny drugmakers face.
(I notice that Applied Apine Technologies received a 522 order on 10-5-09 but there is no oplan listed. Alphatec Spine got one the same date and the FDA says ‘plan overdue.’
Have any of the mesh manufacturers who received the January 3, 2012 522 order, submitted the plan as was requested in a timely manner?
Morgan Liscinsky of the FDA Office of Public Affairs did not reveal how many companies have reported their 522 plan in a timely manner, but she adds that once it is received by the agency it will not be made public.
MDND: Where do these plans appear on the website once they are submitted?
FDA: Submitted study plans are not available on the website. Study plans are considered proprietary and may change prior to being approved by the FDA. Study plans must be approved by the FDA prior to companies beginning the studies. Requests under the Freedom of Information Act (FOIA) may be made as indicated on the following webpage: http://www.fda.gov/RegulatoryInformation/FOI/HowtoMakeaFOIARequest/default.htm.)
MDND: How many 522 plans have been submitted as part of PMA requests since 2009?
FDA: 522 study plans are not submitted as part of PMAs. Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act (the act) is one means by which the Food and Drug Administration (FDA) can obtain additional safety and/or effectiveness data for a device after it has been cleared through the premarket notification (510(k)) process or approved through the premarket approval application (PMA), humanitarian device exemption (HDE), or product development plan (PDP) process, when it is necessary to protect the public health. Postmarket surveillance is not a substitute for obtaining the necessary premarket information to support 510(k) clearance or PMA, HDE, or PDP approval.
MDND: Have any of the mesh manufacturers who received the January 2012 522 order submitted the plan as was requested in a timely manner?
FDA: Study plans were due by February 2, 2012, have been received by FDA, and are under review by a team of subject matter experts.
Off to preparing the FOIA requests and finding out how many were submitted on deadline and what penalty, if any, there is if they are not timely. Stay tuned! #