FDA seeks comment on device reclassification process

November 14, 2011 By MassDevice staff

The FDA is looking for public comment on the medical device reclassification process, through which interested parties can request that a device be subject to more or less regulatory oversight.

The classification system determines a device’s regulatory pathway, with Class III devices subject to the most control and Class I devices subject to "general controls" on branding, registration and other mostly administrative concerns.

Bumping a device into a lower class means manufacturers can bring similar products to the U.S. market more quickly and with fewer regulatory hurdles.

The FDA opened up a public comment period today, extending to mid-January, to get perspective on whether the information gathered during reclassification submissions is necessary and useful, whether it’s gauge on timing and burden is appropriate, and how to improve on the process and minimize burden.

The agency is also looking for ideas on how to use automated collection techniques and other forms of information technology to make the submission process easier.

The watchdog agency estimated that it reviews about six reclassification submissions each year. Each submission takes about 500 hours to process, amounting to about 3,000 hours every year spent on making reclassification decisions.

Suggestions and comments must be sent to the FDA by January 13, 2012, according to an agency notice.

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