POLICY ALERT: FDA releases guidance for devices and biomarkers

August 18, 2011

The Food & Drug Administration (FDA) has released draft guidance pertaining to medical device premarket review and biomarkers related to drug or biotechnology product development.

 

Guidance for Industry: E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions

 

 

Draft Guidance for Industry and Food and Drug Administration Staff - Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review

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draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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.

 

Email Newsletter icon, E-mail Newsletter icon, Email List icon, E-mail List icon Sign up for our Upcoming Events email!
For Email Marketing you can trust

MassBio