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Medical Devices / Regulatory Affairs

FDA Reaffirms Flexibility on GCP Compliance for Device Trials With Final Rule

April 8, 2019
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In a March 19 webinar, the FDA amplified its commitment to exercising discretion when devicemakers seek waivers for new requirements that aim to support quality and integrity of clinical data and protection of human subjects by incorporating good clinical practice (GCP) standards.

A final rule on human subject protection, which went into effect on effect Feb. 21, requires that data from medical device trials be gathered in accordance with GPCs.

It applies to data that supports investigational drug exemption applications, 510(k) submissions and de novo classification requests, as well as applications for premarket approval, product development protocols and humanitarian device exemptions. It also applies to bench and in vitro diagnostic studies of de-identified specimens.

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