FDA Extends Comment Period on GMPs for Hearing Aids

The FDA is extending the comment period to June 30 on draft guidance covering good manufacturing practices for hearing aids.

The agency released draft guidance in January, Streamlining Regulations for Good Manufacturing Practices for Hearing Aids, which clarifies the difference in regulatory requirements between hearing aids and personal sound amplification products (IDDM, Jan. 8).

The agency also held a public workshop in April to outline its perspective on GMPs and to seek stakeholder input on alternative models for regulating hearing aids.

Read the draft guidance here: www.fdanews.com/05-10-16-HearingAidsNotice.pdf. — Joya Patel