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.)

Suggested Articles

The profit margins and management of Community Health Group raise questions about oversight of managed care insurers.

Financial experts are warning practices about the pitfalls of promoting medical credit cards to their patients.

A proposed rule issued by HHS on Tuesday would expand short-term coverage, a move Seema Verma said will have "virtually no impact" on ACA premiums.