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Cochlear Implants and MRI Safety
… purpose. There are some magnet-containing implants for hearing impairment that are not cochlear implants. Examples include bone-anchored or bone conduction hearing aids or middle ear implants. Follow the …
Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices
… 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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
Brochure - Home Healthcare Medical Devices: A Checklist
… caregiver use the device. Are there changes in vision, hearing, ability to move? Have you had an illness, new …
Human Factors Considerations
… and coordination, Sensory abilities (i.e., vision, hearing, tactile sensitivity), Cognitive abilities, including …
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 …
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 …
MiniMed 630G System with SmartGuard - P150001/S021
… SmartGuard should not be used in: People whose vision or hearing does not allow recognition of pump signals and alarm …
Medical Device Supply Chain and Shortages
… Act): Submit a 506J Notification The FDA is interested in hearing from health care facilities and providers having …
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 …