Earlier this year the FDA released its Medical Device Safety Action Plan, aimed at enhancing device safety, building on existing initiatives to further ensure consumer medical devices are safe, and effective. After half a year of review, the FDA will be releasing updates to this Plan addressing new safety concerns as products come on the market, and encouraging both innovations and further safety for these new medical devices.
The updates focus on creating a more robust safety net for medical device consumers, using data analytics to empower both manufacturers and consumers in the development and purchase of new medical devices. The latest updates will also include important information for female-specific medical devices, including surgical mesh for transvaginal surgeries.
The updates are just one of many future goals the FDA has created for itself to “ensure that the FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.”
Although the FDA will never be able to know all the benefits and risks of a device before it reaches the market, its important that upon wider distribution the FDA updates consumers as to a device’s safety and proper use. This plan, and updates to the plan, will help serve as a foundational step towards ensuring ongoing post-market medical device oversite, and empower consumers with the information they need to make educated choices with respect to their medical treatment.
Claude A. Wyle is a partner of Choulos Choulos, and Wyle, a San Francisco based law firm dedicated to representing clients who have been injured by the wrongful conduct of individuals, corporations, public entities, and businesses. Mr. Wyle also frequently sits as a Judge Pro Tem for the city and county of San Francisco.