SILVER SPRINGS, MARYLAND — In a January 6th press release the US Food and Drug Administration (FDA) announced it will host a public workshop, “Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids,” on April 21, 2016, at the FDA’s headquarters in Silver Spring, Maryland.
The workshop will outline the agency’s perspective on the current GMPs that are required under the agency’s Quality Systems Regulation (QSR) and gather stakeholder and public input about alternative models for regulation that would accelerate innovation while still enabling quality design and manufacturing for hearing aids.
Engaging Stakeholders to Improve Hearing Aid Usage
The objective of the workshop, according to the press release, is to better understand how the agency can appropriately balance patient safety while encouraging advancements in hearing aid technology and access to these devices in the United States. This workshop re-opens a public comment period on a draft guidance related to the agency’s premarket requirements for hearing aids and personal sound amplification products (PSAPs).
A report from the President’s Council of Advisors in Science and Technology (PCAST) recently recommended possible modifications to the FDA’s regulation of hearing aids that the council believes could “enhance the pace of innovation” and lead to a “decrease in cost and improvement in capability, convenience and use of assistive hearing devices.”
As a result of the PCAST report, the FDA is further engaging stakeholders to consider how best to ensure that its regulations and policies are clear, up-to-date, well-understood, and that they both protect the public and foster innovation in this important area.
“The FDA recognizes that hearing aids are an important and often underutilized medical device for those with hearing impairment,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.
“Additional insight from all stakeholders will help us to better understand how we can overcome the barriers to access and spur the development of devices that compensate for impaired hearing.”
The FDA, an agency within the U.S. Department of Health and Human Services, is tasked with protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.