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November 6-7, 2019: General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 11/06/2019 - 11/07/2019
… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …
Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication
… Certain contact lenses with metal Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants) Magnetic …
October 26-27, 2022: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Mtg. Announcement - 10/26/2022
… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …
February 2, 2024: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 02/02/2024
… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …
November 29, 2023: Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting Announcement - 11/29/2023
… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …
Certain ResMed Ltd Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication
… Certain contact lenses with metal Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants) Dental …
Letters to Industry
… - July 24, 2018 (PDF - 57KB) IHCTOA 07/24/18 Letter to Hearing Aid Manufacturers about Over-the-Counter (OTC) Hearing Aids - July 24, 2018 (PDF - 67KB) Communication …
2018 Meeting Materials of the Neurological Devices Panel
… 1, 2018 FDA Executive Summary: March 1, 2018 Open Public Hearing Speaker List: March 1, 2018 Panel Questions: March 1, …
November 13-14, 2019: Immunology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 11/13/2019 - 11/14/2019
… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …
AMENDED INFORMATION: October 20, 2022 Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 10/20/2022
… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …
July 28-29, 2022: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 07/28/2022
… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …
Evaluation of Automatic Class III Designation (De Novo) Summaries
… DEN180041 Classification Order Decision Summary Bose Hearing Aid DEN180026 Classification Order Decision Summary … Classification Order Decision Summary EarLens™ Contact Hearing Device DEN150002 Classification Order Decision … Order Decision Summary Widex C4-PA Wireless Air-Conduction Hearing Aid DEN100025 Classification Order Decision Summary …
September 7-8, 2023: Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 09/07/2023
… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …
CDRH 2021 Annual Report
… in Action Digital Transformation Digital Health OTC Hearing Aid Rule Regulatory Science Tools Customer Service … …
Specific Devices for Home Use
… - Getting the Most Out of Your Pump ( PDF version ) Hearing Aids Contact Lenses Home Use Tests Home use tests …
Neurological Devices
… injury. Neurological devices can be used to help restore hearing and sight and provide increased function for those …
Roster of the Ear, Nose, and Throat Devices Panel
… Term: 04/09/20219 – 10/31/2026 Medical Director, Hearing and Balance Center Professor University of Missouri …
Mammography Quality Standards Act Regulations
… the facility with notice and opportunity for an informal hearing in accordance with part 16 of this chapter, that the … may suspend the certificate of a facility before holding a hearing if FDA makes a finding described in paragraph (a) of … provide the facility with an opportunity for an informal hearing under part 16 of this chapter not later than 60 days …
108th Congress Report - House Of Representatives
… after providing notice and an opportunity for an informal hearing, when such person is substantially not in compliance …
Contact Guidelines and Confidentiality
… Comments and Suggestions: The Ombudsman is interested in hearing from you about the effectiveness of our programs and …
Information for Clinicians about Magnetic Field Interference
… CSF shunt valves and magnetic field interference from hearing devices that use magnets, the FDA issued a Letter to …
Labeling Requirements for Specific Devices
… on devices using this propellant as listed under 801.425. Hearing aids 21 CFR 801.420 - Labeling requirements related …
Additive Manufacturing Program: Research on Additive Manufacturing for Medical Devices
… technology to the preferred manufacturing method for hearing aids and metal spine cages. To date, the FDA has …
Information for Professionals
… device motion due to the static magnetic field Tinnitus or hearing loss (temporary or permanent) from loud noises the …
CDRH Ombudsman
… Comments and Suggestions: The Ombudsman is interested in hearing from you about the effectiveness of our programs and …