https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appeal-options-available-mammography-facilities-concerning-adverse-accreditation-decisions?utm_campaign=2020-07-20%20Mammography%20Appeal%20Options%20Draft%20Guidance&utm_medium=email&utm_source=Eloqua

FDA Issues Draft Guidance on Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Physician Notification Orders

Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Physician Notification Orders.

Read the Guidance This draft guidance:  Describes and clarifies what options are available to mammography facilities after receiving an adverse decision that affects a facility’s accreditation in a manner that precludes certification or certification, and/or suspension or revocation of certificate, or a patient and physician notification (PPN) order. Seeks comments from mammography facilities and providers on the provided recommendations. Submit Comments on the Draft Guidance This draft guidance will be open for public comments for 60 days at https://www.regulations.gov under Docket Number FDA-2020-D-1317. Questions? If you have any questions about this guidance document, contact the Division of Industry and Consumer Education (DICE).