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Noise Claims in Hearing Aid Labeling - Guidance for Industry
… tory-information/search-fda-guidance-documents/noise-claims-hearing-aid-labeling-guidance-industry … PDF Printer Version … the guidance you are requesting. Noise Claims In Hearing Aid Labeling Manufacturers who make noise claims in their labeling for hearing aids (e.g. improved speech understanding in noisy …
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products
… ation/search-fda-guidance-documents/regulatory-requirements-hearing-aid-devices-and-personal-sound-amplification-products … Federal Food, Drug, and Cosmetic Act (the FD&C Act) for hearing aids and for personal sound amplification products (PSAPs). A lack of clarity between PSAPs and hearing aids has contributed to stakeholder and consumer …
Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Physician Notification Orders
… FDA’s reconsideration decision, it may request a formal hearing before the Departmental Appeals Board, Department of … and Human Services, as well as further review of the hearing officer’s decision. A mammography facility that … Standards Act (MQSA) may request an informal (regulatory) hearing before the FDA as described below. The FDA has …
Center for Devices and Radiological Health (CDRH) Appeals Processes
Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff
… square (rms) sound pressure level greater than 99 dBA with hearing protection in place. These criteria apply only to …