FDA releases medical device draft guidance for clinical studies and premarket review

On Aug. 15, the U.S. Food and Drug Administration announced that it is seeking comment for two sets of proposed guidelines.  One is the draft guidance for Design Considerations for Pivotal Clinical Investigations for Medical Devices.  The intent is to help researchers and manufacturers design better quality clinical studies in support of premarket approval (PMA) applications for medical devices. Submit electronic comments on the draft guidance to https://www.regulations.gov by Nov. 14, 2011. Identify comments with docket number FDA–2011–D–0567.

The other draft guidance is for Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review. It clarifies how benefit-risk determinations are made during premarket review of certain medical devices.  Submit electronic comments on the draft guidance to https://www.regulations.gov by Nov. 14, 2011. Identify comments with docket number FDA–2011–D–0577.