FDA investigated for improper review of medical devices

Recently we've reported several times about the FDA's rather limited review process for medical devices. Now, it seems Congress is getting worried about this issue. In fact, several Congressional representatives are launching an investigation into whether some medical devices were improperly approved without being sufficiently vetted.

Apparently some of the scientists at the Center for Devices and Radiological Health (CDRH) blew the whistle on some of their managers in a letter, saying that the managers had interfered with the approval process and threatened reprisals against employees who tried to follow the regulatory rules.

The committee, which is being headed up by Michigan Democratic representatives John Dingell and Bart Stupak, has said that it has been provided with compelling evidence to support the charges in the letter.

To learn more about the accusations:
- read this Modern Healthcare piece (reg. req.)

Related Articles:
FDA should regulate medical devicemakers' DTC advertising
FDA to tighten medical device safety regs
FDA's medical approval process faces GAO scrutiny

Post a comment