Proposed Legislation Would Allow for Conditional Clearance of Medical Devices

Posted 01 June 2012 | By

A new piece of legislation introduced in the House of Representatives on 30 May by Rep. Bruce Braley (D-IA) would give the US Food and Drug Administration (FDA) additional oversight of medical device recalls and allow certain medical devices to receive conditional clearance from the agency.

Braley's bill, the Medical Device Patient Safety Act, is similar to a piece of legislation of the same name introduced in December 2011 in the Senate by Sens. Charles Grassley (R-IA), Richard Blumenthal (D-CT) and Herb Kohl (D-WI).

The bill's first main provision calls upon FDA to establish a program to "routinely and systematically assess" medical device recalls, corrections or removals from the market. The program would then be charged with using the collected information to "proactively identify strategies for mitigating health risks presented by defective or unsafe devices."

The program would specifically be looking at recall trends, including the underlying causes of recalls, types of devices recalled, the risk class of each recalled device, the length of time needed to recall the product from the market, whether FDA has performed a device recall audit check, other recalls by the same organization and "any other information" deemed by FDA to be appropriate.

The analysis of each company's recall information would then be made public after 180 days of the termination of the recall notice.

The bill's other primary provision would allow FDA to "conditionally clear for introduction into interstate commerce" certain medical devices subject to a 510(k) approval pathway. The 510(k) clearance program allows devices to bypass clinical trial testing if it can prove it is "substantially equivalent" to a predicate device already approved by FDA.

Under the proposed conditional approval program, FDA could limit the device's sale and distribution while the device is undergoing further evaluation, including potential testing of its safety, effectiveness and reliability. The agency would be required to provide the information required of the company at the time of the conditional approval.

The device manufacturer could also be required to submit to FDA periodic reports containing information such as any new indication for use of the device, labeling changes, manufacturing facility changes, new processing procedures, changes to the device's design or specifications or other changes unlikely to affect safety or effectiveness.

Manufacturers found to not be in compliance with the terms FDA establishes for the conditional clearance may find their products ordered removed from the market.

The bill has been referred to the House Committee on Energy and Commerce for review.

Read more:

H.R. 5866 - To enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes.


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