FDA Wants Your Patient Preference Input for Medical Device Regulatory Processes
After a surprisingly busy summer, the FDA is leaping into September with a two-day meeting where you can be the star — or on the defensive.
Mark your calendar for Sept. 18-19 at FDA headquarters in Rockville, MD for “The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Processes.”
FDA’s goal is to open a dialogue on the best ways to incorporate patient preferences on the benefit-risk tradeoffs of medical devices into the full spectrum of the Center for Devices and Radiological Health (CDRH) regulatory decision making.
It also aims to advance the science of measuring treatment preferences of patients, caregivers, and health care providers. The agency intends to use information gleaned from the workshop and subsequent public comments to help regulators, industry, providers, patients, and device innovators to get on the same page.
Meantime, FDA’s busy summer included a slew of new warning letters. In Taiwan, Soleetech Corporation, a manufacturer airway (extension) connectors, flat out told the FDA it didn’t have, and didn’t plan to develop, any kind of Corrective and Preventative Action (CAPA).
I understand that different nations have different cultural quirks, but telling the FDA you aren’t much interested in CAPA is a universally bad idea.
August was indeed a busy warning letter month. As of August 22, more than dozen had already been issued. And with the month not over, and a lag time in posting some letters, August is shaping up to be a big enforcement month.
Nearly half of August’s warning letters zeroed in on Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) alleged shortcomings. Typical of this trend was an August 8 letter to Healing Dives Inc.
So, as we all drive back from the beach, it’s time to examine FDA’s next moves. Look for an upcoming post from fellow blogger and former FDA inspector Patrick Stone with his wish list for what he views as the FDA’s most burning issues in September and beyond.