Test Kits Included in Class 1 Devices Exempt from 510k Filing

The FDA has determined that 71 device types, including some diagnostic test kits, should be exempt from 510k filings. These devices are deemed “sufficiently well understood and do not present risks that require premarket notification to provide a reasonable assurance of safety and effectiveness,” the FDA said in a statement regarding the determinations. Generally, devices introduced to market after 1976 require either FDA notice under 510k or premarket approval, depending on their risk classification. Class 1 devices are the lowest risk devices, for which the agency has determined general controls will be “sufficient to assure safety and effectiveness.” A 510k filing gives the FDA notice of the intent to market the device and allows the FDA to decide if the new device is “substantially equivalent” with a device already on the market that doesn’t require full premarket approval. The FDA announced the 71 class I device types in a notice published in the April 13, 2017 Federal Register. It is the result of efforts to streamline agency review under the 21 Century Cures Act, which was signed into law in December 2016.

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INDUSTRY NEWS TAGS: Molecular Diagnostics

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