U.S. FDA Clarifies Rules on De Novos for Medical Device Accessories
Sponsors hoping to gain de novo status for new medical device accessories should prepare submissions closely mirroring those for stand-alone devices, the FDA says.
Requests for de novo status should include descriptions of the accessory and its parent device and detailed reasons for any recommended classification for the accessory, recent guidance says. The request should identify all devices with which the accessory can be used, including model numbers or connector types, if appropriate. The request should also identify any potential risks associated with the accessory, proposed mitigation measures and a summary of supporting performance data.
The draft guidance is intended to clarify how the current risk-based regulatory framework applies to accessory devices.
Proposed labeling submitted as part of the de novo process should include instructions on how to use the accessory with the parent device and address potential compatibility concerns. Sponsors should also include an executive summary incorporating key information, such as a performance data summary and risk and mitigation information.
The FDA defines an accessory as any device “intended to support, supplement and/or augment the performance of one or more parent devices.” An example would be a rechargeable battery used with an automated external defibrillator, because it allows the AED to function. A balloon catheter used to insert an approved transcatheter heart valve into a smaller diseased artery would also be an accessory since it acts as a supplement to the valve’s intended use.
Classification of accessories is subject to the same control scheme as that for stand-alone devices, the FDA notes. De novos will be granted if the accessory falls into Class I or Class II. Class III accessories require PMA approval.
Comments are due March 23 to docket no. FDA-2015-D-0025.
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