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The FDA hosted this webinar to share information about implementation of the final rule on “Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices.” The rule updates the standards for accepting clinical data from clinical investigations
- conducted inside the United States
- conducted outside the United States.
The purpose of the rule is
- to protect human participants
- to ensure the quality and integrity of data obtained through such investigations.
The final rule applies to all clinical investigations that enroll the first subject on or after February 21, 2019, and support any of the following:
- investigational device exemptions (IDE),
- premarket notifications (510(k)),
- requests for De Novo classification,
- premarket approvals (PMA),
- product development protocols (PDP),
- humanitarian device exemptions (HDE).