Minnesota's entire Congressional delegation has sent a letter to the FDA criticizing its review process for new medical devices, according to a report by MedCity.
The letter cited industry research showing only 56 percent of device applications for an Investigational Device Exemption were given the exemption in the first review cycle in 2009, down from 76 percent in fiscal year 2000. The letter asked the FDA for an explanation of the substantial drop.
A week earlier, Sen. Al Franken (D-Minn.) sent the FDA a letter asking the agency to include industry perspective when the Institute of Medicine issues its recommendations on the agency's 510(k) approval process and before any final changes are made to it.
Read the MedCity report on FDA device approval.
Related Articles on Criticisms of the FDA Medical Device Approval Process:
FDA Pressed to Speed Up Device OKs Before Fee Reauthorization
GAO Report: FDA Should Tighten Oversight of Device Recalls
Study: No Safety Benefit Recognized From Slower, Burdensome FDA Approval Process for Devices