FDA issues new draft guidance on Class III de novos, UDI for small entities

The FDA proposes guidance for its de novo medical device review pathways and finalized its advice for small companies who must comply by the new Unique Device Identifier rules.

The FDA issued a pair of new documents this week outlining the agency's thinking on review of breakthrough medical devices and providing guidance for small companies trying to keep up with the new Unique Device Identifier program.

In a draft guidance proposed today the FDA offered some advice for companies developing novel devices that they believe are low-risk and thus eligible for more lenient review.

Food & Drug Administration (FDA)

News Well, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance, Universal Device Identifier (UDI)

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