Medical Devices

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

The Food and Drug Administration (FDA) announced the following public workshop titled "Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids."  The topic discussed was the appropriate level of Good Manufacturing Practices (GMPs) regulation to ensure the safety and effectiveness of air-conduction hearing aid devices.


Date, Time and Location

This meeting was held April 21, 2016, beginning at 8:30 am - 5:30 pm at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

Agenda

8:30AM – 8:35AM

Welcome:

  • Malvina Eydelman, Office of Device Evaluation, CDRH

8:35AM – 8:50AM

Opening Remarks:

  • Robert Califf, FDA Commissioner

8:50AM – 9:10AM

President’s Council of Advisors on Science and Technology (PCAST) Report:

9:10AM – 9:30AM

Institute of Medicine (IOM) Update:

9:30AM – 9:50AM

Overview of FDA’s Hearing Aid Regulations:

9:50AM – 10:05AM

Coffee Break

10:05AM – 1:10PM

Public Speakers’ Session

1:10PM – 2:10PM

Lunch

2:10PM – 3:10PM

 

Invited Session #1 – Hearing Aid Access:

3:10PM – 4:10PM

Invited Session #2 – PCAST Proposed Stratification of Hearing Aids:

4:10PM – 4:25PM

Coffee Break

4:25PM – 5:25PM

Invited Session #3 – Quality Standards for Manufacturing Hearing Aids:

5:25PM – 5:30PM

Concluding Remarks: CDRH

Webcast Archive

Transcript

Registration

As of April 13, 2016, online registration is now closed. On-site registration will be available the morning of the workshop for persons interested in attending this event.

Contact Us

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, susan.monahan@fda.hhs.gov.

For questions regarding workshop content please contact:

Srinivas Nandkumar, Ph.D., Food and Drug Administration, Center for Devices and Radiological Health, Bldg. 66/Room 2436, 10903 New Hampshire Avenue, Silver Spring, MD  20993, 301-796-6480, FAX:301-847-8126, email: Srinivas.nandkumar@fda.hhs.gov.

Page Last Updated: 05/23/2016
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