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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 …
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 …
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 …
CDRH 2021 Annual Report
… in Action Digital Transformation Digital Health OTC Hearing Aid Rule Regulatory Science Tools Customer Service … …
510(k) Third Party Performance Metrics and Accreditation Status
… after providing notice and an opportunity for an informal hearing, when the accredited third party is substantially not …
Medical Device & Radiological Health Regulations Come of Age