FDA offers guidelines on device ID rule, de novo review process

08/15/2014 | MassDevice.com (Boston)

The FDA has released its final guidelines on how small firms may satisfy the unique device identifier rules, including information related to the appearance of UDIs, rule exceptions and record-keeping standards. The agency also issued a draft document meant to guide companies when submitting Class III medical devices under the agency's de novo review program.

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MassDevice.com (Boston)

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