GUIDANCE DOCUMENT
Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders Guidance for Mammography Facilities and Food and Drug Administration Staff September 2024
- Docket Number:
- FDA-2020-D-1317
- Issued by:
-
Guidance Issuing OfficeCenter for Devices and Radiological Health
The FDA issued this guidance to describe the processes available to mammography facilities to request additional review of an adverse appeals decision on a facility’s accreditation, and/or a suspension or revocation of certificate, and/or a patient and referring provider notification (PPN) order.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-1317.