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GUIDANCE DOCUMENT

Center for Devices and Radiological Health Appeals Processes Guidance for Industry and Food and Drug Administration Staff May 2013

Final

Center for Devices and Radiological Health Appeals Processes

Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document describes the processes available to outside stakeholders to request additional review of decisions or actions by Center for Devices and Radiological Health (CDRH or the Center) employees. This guidance supersedes “Medical Device Appeals and Complaints: Guidance for Dispute Resolution,” dated February 1998 and “Resolving Scientific Disputes Concerning The Regulation of Medical Devices, A Guide to Use of the Medical Devices Dispute Resolution Panel; Final Guidance for Industry and FDA,” dated July 2001.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.