Last Thursday, Senators Chuck Grassley (R-Iowa), Richard Blumenthal (D-Conn), and Herb Kohl (D-Wis.) introduced the Medical Device Patient Safety Act, which aims “to enhance Food and Drug Administration oversight of medical device recalls [and] to provide conditional clearance of certain medical devices.” The proposed legislation sets forth a program by which FDA is to gather information regarding device recalls ordered under 21 U.S.C. § 360h(e) and information submitted when a device is corrected or removed under 21 U.S.C. § 360i(g). According to the Bill, FDA is to use this information “to proactively identify strategies for mitigating health risks presented by defective or unsafe devices.” The program should gather any information FDA deems appropriate, which would at least include: trends in the recalls, the most frequently recalled devices, the causes of the recalls, the time needed to complete the recall, the time FDA needs to terminate the recall, whether there have been recall audit checks, and persons who have been subjected to the most recalls.
The Bill dictates that FDA is to develop “explicit criteria” to evaluate if an individual has sufficiently complied with a recall, and FDA is to document the bases for any recall terminations, which it shall publish within 180 days of the termination. According to The Gray Sheet, members of the device industry have voiced support for an improved device recall process claiming that FDA has been “slow to classify recalls or announce when a recall has been successfully completed.” (Senate Bill Would Allow 510(k) Condition of Clearance Studies – The Gray Sheet, Dec. 19, 2011.) AdvaMed’s Executive Vice President of Technology and Regulatory Affairs, Janet Trunzo, stated, “FDA could do more to enhance the clarity and consistency of its recall process, and we are pleased that the agency has a number of initiatives underway in this area.”
Support for the Bill’s proposals is not unanimous; however, as some industry representatives claim the Conditional Clearance section is unnecessary. This part of the Medical Device Patient Safety Act would add Section 510A to the Federal, Food, Drug, and Cosmetic Act to allow for the conditional clearance of medical devices approved pursuant to Section 510(k). Currently, FDA lacks significant resources and authority to perform such monitoring. The Agency can only require post-approval studies for Class III PMA devices and certain 510(k)-cleared and PMA-approved devices. Under the proposed Bill, FDA would have the authority to rescind an approval if an applicant failed to meet the conditions for approval.