POLICY ALERT: FDA releases guidance for devices and biomarkers
The Food & Drug Administration (FDA) has released draft guidance pertaining to medical device premarket review and biomarkers related to drug or biotechnology product development.
You can submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.