This guidance document is being distributed for comment purposes only. Document issued on: March 5, 2013
You should 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draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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.
For questions regarding this document, contact the Premarket Notification (510(k)) Section or the Premarket Approval (PMA) Section of CDRH at 301-796-5640 or CBER’s Office of Communication, Outreach and Development at 1-800-835-4709 or 301-827-1800.
When final, this document will supersede “Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements” dated February 28, 2008.