CDRH Industry: Public Workshop - Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids, April 21, 2016

The Food and Drug Administration (FDA) is holding a public workshop to discuss the appropriate level of Good Manufacturing Practices (GMPs) regulation to ensure the safety and effectiveness of air-conduction hearing aid devices.  In addition, FDA has re-opened a public comment period on a draft guidance related to the agency’s premarket requirements for hearing aids and personal sound amplification products (PSAPs).

• Workshop
• Draft Guidance
• Federal Register explaining reopening of comment period for draft guidance