The Institute of Medicine has completed its internal review of the FDA's 510(k) clearance process of medical devices and is now turning to the private sector to obtain feedback on its review, according to a Mass Device news report.
The IOM's review comes as the FDA faces pressure to reform its device approval process. An expert panel has been assembled to review the IOM's review, but the medical device industry has been outspoken about the lack of representation from its own sector. On behalf of the medical device industry, Sen. Al Franken (D-Minn.) also urged IOM for greater representation of medical device companies.
Consequently, IOM reached out to Medtronic veteran Dale Wahlstrom for suggestions on which medical device industry representatives to include on the expert panel. No details have been disclosed as to Mr. Wahlstrom's suggestions or whether any of the suggested individuals were contacted by IOM.
Read the news report about the IOM review of 510(k) protocol.
Read other coverage about the medical device approval process:
- FDA May Toughen Medical Device Approval Process
- FDA Orders Study of Premarket Clearance Process for Medical Devices
The IOM's review comes as the FDA faces pressure to reform its device approval process. An expert panel has been assembled to review the IOM's review, but the medical device industry has been outspoken about the lack of representation from its own sector. On behalf of the medical device industry, Sen. Al Franken (D-Minn.) also urged IOM for greater representation of medical device companies.
Consequently, IOM reached out to Medtronic veteran Dale Wahlstrom for suggestions on which medical device industry representatives to include on the expert panel. No details have been disclosed as to Mr. Wahlstrom's suggestions or whether any of the suggested individuals were contacted by IOM.
Read the news report about the IOM review of 510(k) protocol.
Read other coverage about the medical device approval process:
- FDA May Toughen Medical Device Approval Process
- FDA Orders Study of Premarket Clearance Process for Medical Devices