Advertisement
News
Advertisement

FDA releases 180-day PMA memos

Thu, 07/12/2012 - 11:12am
Mass Device

The FDA's Center for Devices & Radiological Health releases a smattering of summary review memos of 180-day design changes to medical devices that have already won a green light from the federal watchdog agency.

FDA logo

The FDA's Center for Devices & Radiological Health released a selection of summary review memos detailing applications to make substantial changes to already-approved medical devices.

The federal watchdog agency's med-tech oversight arm said it began releasing the documents as part of the CDRH's transparency initiative.

The 180-day supplements seek to make "a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report," according to the agency.

Advertisement

Share this Story

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading