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September 8-9, 2020: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 09/08/2020 - 09/09/2020
… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing sessions. The contact person will notify interested …
POSTPONED: April 16, 2020 Circulatory System Devices Panel of the Medical Devices Advisory Committee Announcement - 04/16/2020 - 04/16/2020
… 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 2-3, 2021: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 11/02/2021
… reasonably accommodated during the scheduled open public hearing session, FFDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …
April 6, 2021: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 04/06/2021 - 04/06/2021
… 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 …
August 22-23, 2023: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 08/22/2023
… 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 …
May 23, 2024: Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting Announcement - 05/23/2024
… 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 …
Mammography Quality Standards Act (MQSA)
… paragraph (2), reasonable notice and an opportunity for a hearing to the owner or operator of the facility, that the … under subsection (h) of this section. (2) Action before a hearing (A) In general The Secretary may suspend the certificate of the facility before holding a hearing required by paragraph (1) if the Secretary has reason …
POSTPONED: April 23-24, 2020 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 04/23/2020 - 04/24/2020
… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing sessions. The contact person will notify interested …
FDA Letter Regarding NCVHS Recommendation on the Updated Version of the X12 Standard for Claims and Electronic Remittance Advice Transactions
… version. Concerns raised via public comments and public hearing regarding inclusion of UDI are similar to those that …
Endolymphatic Shunt Tube with Valve - Class II Special Controls Guidance for Industry and FDA
… in the inner ear to relieve the symptoms of vertigo and hearing loss due to endolymphatic hydrops of Meniere's … in the inner ear to relieve the symptoms of vertigo and hearing loss due to endolymphatic hydrops (increase in … in the inner ear to relieve the symptoms of vertigo and hearing loss due to endolymphatic hydrops (increase in …
March 21-22, 2018: Joint Meeting of the Blood Products Advisory Committee and the Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 03/21/2018
… 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 …
March 29-30, 2018: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 03/29/2018
… 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 …
September 6, 2023: Patient Engagement Advisory Committee Meeting Announcement - 09/06/2023
… 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 …
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, …
PMA Approvals
… PMA application. A petitioner may request either a formal hearing under 21 CFR part 12 of FDA's administrative … A petitioner shall identify the form of review requested (hearing or independent advisory committee) and shall submit …
POSTPONED: October 5, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 10/05/2016
… 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: Letter to Health Care Providers
… 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 …
February 12, 2019: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 02/12/2019 - 02/12/2019
… 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 …
August 16, 2016: Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 08/16/2016
… 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 …
June 2-3, 2016: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments - 06/02/2016
… 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 …
September 20-21, 2016: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, Establishment of a Public Docket, Request for Comments - 09/20/2016
… 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 1, 2022: Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 11/01/2022
… 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 6, 2024: General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 02/06/2024
… 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 …
Repetitive Transcranial Magnetic Stimulation (rTMS) Systems - Class II Special Controls Guidance for Industry and FDA Staff
… 8. Electromagnetic Compatibility Section 11. Labeling Hearing loss Section 11. Labeling 4. Device Description We … significant heart disease, cerebrovascular disease, or hearing loss, history of epilepsy, cerebrovascular disease, … bone growth stimulators, earrings and other jewelry, hearing aids, eyeglasses, cell phones, and MP3 players. The …
February 25-26, 2016: Gastroenterology and UrologyDevices Panel of the Medical Devices Advisory Committee Meeting Announcement - 02/25/2016
… 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 …