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Hearing Aids and Cell Phones
… /radiation-emitting-products/cell-phones/hearing-aids-and-cell-phones … Before you buy a cell phone, … to see which phone works best for you. People who wear hearing aids or have implanted hearing devices may experience some difficulties when trying …
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 …
Mammography Facility Adverse Event and Action Report - June 30, 2022: Capitol Radiology, LLC doing business as Laurel Radiology Services
… Revoke Certificate, along with notice of opportunity for hearing, explaining the supporting facts and attaching the … Capitol Radiology ten business days to request an informal hearing regarding the proposed revocation. On January 27, … notice by email that it was requesting an informal hearing regarding CDRH's proposed revocation of Capitol …
CDRH 2022 Annual Report
… (MDUFA) V, Device Innovation, Over-the-Counter (OTC) Hearing Aid Final Rule, and Device Safety. Read the Report … Authorizations for Novel Devices Digital Health OTC Hearing Aid Final Rule Device Safety Recalls Cybersecurity …
IDE Enforcement of Good Clinical Practices (GCP) Regulations
… investigator will be given an opportunity for a regulatory hearing under 21 CFR 16 on the question of whether the … the sponsor who will have an opportunity for a regulatory hearing. If a danger to the public health exists, however, … the sponsor will have an opportunity for a regulatory hearing before FDA on the question of whether the IDE should …
IDE Approval Process
… respond to the deficiencies and/or to request a regulatory hearing under 21 CFR Part 16. Once an IDE application is … request as a disapproval of the application and request a hearing in accordance with 21 CFR 16. The clinical … advise the sponsor of the right to request a regulatory hearing under 21 CFR 16. FDA will provide an opportunity for …
General Controls for Medical Devices
… all interested persons an opportunity for an informal hearing on the proposal, the Agency will affirm, modify, or … the FDA, after offering an opportunity for an informal hearing, to order manufacturers, importers, or distributors … or refund (3-R) if, after opportunity for an informal hearing , it determines that: The device represents an …
List of Patient Preference-Sensitive Priority Areas
… Ear, Nose, and Throat Treatments for moderate to severe hearing loss (implanted hearing devices vs. other treatment options) Ear, Nose, and … Tradeoffs Related to: Treatments for moderate to severe hearing loss (implanted hearing devices vs. other treatment …
PMA Review Process
… application a notice of opportunity for an informal hearing under 21 CFR 16. If the applicant does not request a hearing or, if after the 21 CFR 16 hearing is held, FDA decides to proceed with the withdrawal, …
Labeling Requirements for Specific Devices
… on devices using this propellant as listed under 801.425. Hearing aids 21 CFR 801.420 - Labeling requirements related …
Human Factors Considerations
… and coordination, Sensory abilities (i.e., vision, hearing, tactile sensitivity), Cognitive abilities, including …
MQSA: Other Resources
… to calls in English and Spanish . Deaf and hard of hearing callers with TTY equipment may call 1-800-332-8615. …
Importing Medical Devices and Radiation-Emitting Electronic Products into the U.S.
… of sampling Sec. 1.91 - Payment for samples Sec. 1.94 - Hearing on refusal of admission Sec. 1.95 - Application for …
Recent Final Medical Device Guidance Documents
… and FDA Staff 08/17/22 Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products …
Mammography Facility Adverse Event and Action Report – February 7, 2023: Advanced Women Imaging
… Revoke Certificate, along with notice of opportunity for hearing, explaining the supporting facts and attaching the …
Labeling Requirements for Radiation Emitting Devices and Products
… of telephones, FDA set and enforced guidelines to prevent hearing injuries. This section will cover labeling of …
Class II Special Controls Documents
… Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS) - Guidance for Industry and FDA …
CDRHNew - News and Updates
Summary of the Medical Device User Fee and Modernization Act of 2002
… accreditation (following an opportunity for an informal hearing) if we find an accredited person is "substantially … our accreditation pending an opportunity for an informal hearing. Id. Not all establishments are eligible for …
Recalls, Corrections and Removals (Devices)
… in the order will have an opportunity for a regulatory hearing or to provide a written request to FDA asking that …
Exemptions From Electronic Product Regulations
… and will also be given an opportunity for a regulatory hearing on the matter. Upon receiving the notice, the …
Withdrawn or Expired Guidance
… Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids - Guidance for Industry and Food and Drug …
CDRH Learn
… Program Presentation Printable Slides Transcript Hearing Aids and Personal Sound Amplification Products …