FDA seeks comment on device detention rules

February 8, 2013 by MassDevice staff

The FDA proposes to renew the inspection protocols for banned medical devices and is seeking more - make that any - comment from the public.


Having pursued less than 1 device detention annually over the past several years, the FDA is proposing once again to extend and renew the program that collects information about medical devices, submitting the proposed changes to the Office of Management & Budget for approval.

Last year, the FDA asked the public for more information about risky or harmful devices but didn't receive a single comment. The watchdog agency is now extending the information-gathering procedures for banning a device.

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The FDA is also asking the public to provide more feedback on products and methods of banning medical devices in general. This action is spurred by the Paperwork Reduction Act, which aims to maximize public benefit of government protocols and regulatory documents.

According to Daniel Gittleson, an analyst at the Paperwork Reduction Act staff, this information collection program needs to be re-approved by the Office of Management and Budget every 3 years.

The Obama administration recently called for a 5% boost to the budget for the FDA's medical device arm, the CEnter for Devices & Radiological Health. With the proposed extension of device detention policies, the CDRH hopes that the public will provide more feedback about the program.