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Labeling Requirements for Radiation Emitting Devices and Products
… of telephones, FDA set and enforced guidelines to prevent hearing injuries. This section will cover labeling of …
Remarks by FDA Commissioner Robert M. Califf to the Coalition for Health AI (CHAI) - 03/05/2024
… data as a “one-off” activity. Not surprisingly, I’m hearing that the “effectiveness” metric being used by health …
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 …
CDRHNew - News and Updates
Summary of the Medical Device User Fee and Modernization Act of 2002
… accreditation (following an opportunity for an informal hearing) if we find an accredited person is "substantially … our accreditation pending an opportunity for an informal hearing. Id. Not all establishments are eligible for …
Process for Handling Referrals to FDA Under 21 CFR 50.54 - Additional Safeguards for Children in Clinical Investigations
… led to the referral Summary of public comments Open public hearing Presentation of questions Expert panel discussion …
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 …
CDRH Learn
… Program Presentation Printable Slides Transcript Hearing Aids and Personal Sound Amplification Products …
Withdrawn or Expired Guidance
… Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids - Guidance for Industry and Food and Drug …
Remarks by Anna Abram to the Biocom Celebration of Life Dinner - 11/21/2019
… and interchangeable insulin products. We held a public hearing to seek public input on the topic and we have been …