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Center for Devices and Radiological Health (CDRH) Appeals Processes
Notify the FDA About a Medical Device Supply Issue
… Medical Device Supply Issues The FDA is interested in hearing from health care facilities and providers having …
Human Factors Considerations
… and coordination, Sensory abilities (i.e., vision, hearing, tactile sensitivity), Cognitive abilities, including …
CDRH Patient Engagement
… from the medical devices that it regulates. Benefits of hearing from patients could be experienced at all stages of …
Sharps Disposal Containers in Health Care Facilities
… associated with medical devices. The FDA is interested in hearing from health care facilities and providers …
Oxygenator Devices Used for Extracorporeal Circulation - Letter to Health Care Providers
… Reporting Problems to the FDA The FDA is interested in hearing from health care providers and facilities who have …
MQSA: Other Resources
… to calls in English and Spanish . Deaf and hard of hearing callers with TTY equipment may call 1-800-332-8615. …
Are There "FDA Registered" or "FDA Certified" Medical Devices? How Do I Know What Is FDA Approved?
… the company name and click Search. Example: Search for Hearing Aids Check for Emergency Use Authorizations: In …
Medical Device Supply Chain and Shortages
… Act): Submit a 506J Notification The FDA is interested in hearing from health care facilities and providers having …
Information for Patients About Dental Amalgam Fillings
… Difficulties with coordination Visual changes Changes in hearing Should Dental Amalgam Fillings Be Removed? If your …
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 …
Medical Device Bans
… comment period. Interested persons may request an informal hearing to discuss the ban. Final Ban A final ban is the …
Explore Life at CDRH
… safe, and effective medical devices. As a hard-of-hearing engineer, I also volunteer time on disability …
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 …
MDSAP AU P0026: Certificate Document Requirements
… generators, endoscopes, examination gloves, guide wires, hearing aids, haemodialysis water purification systems, …
Over-the-Counter (OTC) Medical Devices: Considerations for Device Manufacturers
… A: Consumers may have different physical, sensory (vision, hearing, tactile), cognitive, and emotional abilities than …
Class II Special Controls Documents
… Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS) - Guidance for Industry and FDA …
Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19
… Device Shortages List web page. The FDA is interested in hearing from health care facilities and other stakeholders …
Non-Invasive Body Contouring Technologies
… frequencies higher than the upper audible limit of human hearing. Ultrasound may be used therapeutically to treat …
January 2022 510(K) Clearances
… AVAILABLE FROM FDA DEVICE: BHA100 Series Braun Clear Hearing Aid Kaz USA, Inc., a Helen of Troy Com510(k) NO: … SUMMARY AVAILABLE FROM FDA DEVICE: Jabra Enhance Plus GN Hearing A/S 510(k) NO: K213424 (Traditional) ATTN: Lars …
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 …