Legislation Would Authorize Conditional Clearance for 510(k)s
BY LAUREN UZDIENSKI, DECEMBER 19, 2011
New legislation introduced by Senators Chuck Grassley (R-Iowa), Richard Blumenthal (D-Conn.), and Herb Kohl (D-Wis) would add a new layer of authority to the FDA's 510(k) pathway. If the bill is passed by Congress, the FDA would be granted the option of "conditional" 510(k) clearance, whereby the agency can require further post-market evaluation. Conditional approval is commonly associated with PMAs.
Commentary from FDA Law Blog voiced concern that the language of the bill did not specify when conditional clearance would be exercised or for what types of devices. The industry has generally been opposed to further regulating the 510(k) pathway, but this bill could have a positive impact: the article suggests that more post-market authority could reduce the pre-market data burden, which in turn could lessen some of the delays and unpredictability of bringing a product to market.
The legislation also includes provisions for recalls, namely that the FDA would be required to track and trend recalls, regardless of whether they were initiated by the agency or the manufacturer. However, the collected data could not be uses as a basis for removing a device from the market.
