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FDA Issues Final Guidance on Appeal Processes and Options Available to Mammography Facilities Today, the U.S. Food and Drug Administration (FDA) issued the final guidance: Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Physician Notification (PPN) Orders. The Mammography Quality Standards Act (MQSA) requires mammography facilities to meet certain requirements and be certified before providing mammograms. For a facility to be certified, it must meet certain requirements including be accredited by an FDA-approved accreditation body. A mammography facility can request additional review of an adverse appeals decision by their accreditation body on a facility's accreditation, FDA's suspension or revocation of their MQSA certificate, and/or a patient and provider notification (PPN) order issued by the FDA. For consistency with the final guidance, the FDA also updated the mammography section of the guidance, Center for Devices and Radiological Health (CDRH) Appeals Processes. Both of the guidance documents: - Describes and clarifies what options are available to mammography facilities after receiving an adverse decision that affects their accreditation. For example, the process to appeal an accreditation body's decision to revoke accreditation.
- Describes how mammography facilities can challenge a suspension or revocation of a MQSA certificate.
- Describes how facilities may request a review of a PPN ordered by the FDA.
Questions? If you have questions about either guidance document, contact the Division of Industry and Consumer Education. | 
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