Devices

Reg on Medical Device Clinical Trial Data

FDA will publish 2/21 an amendment to its regulations on accepting data from clinical investigations for medical devices. The agency says the change will require that data submitted from clinical investigations held outside the U.S. intended to support an IDE, 510(k), request for de novo classification, PMA, PDP, or HDE be from investigations conducted in accordance with good clinical practice, including obtaining and documenting the review and approval of the clinical investigation by an independent ethics committee and obtaining and documenting freely given informed consent of subjects, including individuals whose specimens are used in investigation of medical devices.

“The final rule updates the criteria for FDA acceptance of data from clinical investigations conducted outside the United States to help ensure the quality and integrity of data obtained from these investigations and the protection of human subjects,” the regulation says. “As part of this final rule, we are also amending the IDE, 510(k). and HDE regulations to address the requirements for FDA acceptance of data from clinical investigations conducted inside the United States. The final rule provides consistency in FDA requirements for acceptance of data from clinical investigations, whatever the application or submission type.”

The rule will be effective 2/21/19

The agency also is publishing 2/21 a question-and-answer guidance on acceptance of medical device clinical investigation data.

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