According to a Government Accountability Office (GAO) report out Thursday, the Food and Drug Administration is quick to approve some high risk medical devises for use in patients. The long anticipated 64 page report provides ammunition for critics who claim the FDA is too close to makers of medical devices, allowing potentially unsafe products to be used on patients.

Dr. Peter Lurie, of the consumer advocacy group Public Citizen said, "The report certainly confirms our suspicions that FDA uses a variety of means to lessen the regulatory burden on industry.'

This follows last weeks letter by a group of FDA doctors and scientists sent to President-elect Barack Obama's transition team to say that managers in the agency division responsible for regulating devices "have ignored the law and ordered physicians and scientists to assess medical devices employing unsound evaluation methods."

Devises are classified by the FDA by the amount of risk they pose to the user with the least risky devises such as tongue depressors and elastic bandages being put in class I. Mercury thermometers, blood pressure cuffs and other such devises fall in class II which is middle risk while the riskiest are pacemakers, replacement heart valves etc which are class III.

As per FDA regulations medical devises are put through one of the two types of review before they can be legally marketed in the country. The 510 (k) review process is the quicker and less expensive review which generally class I and class II devises go through. Class III devises goes through the PMA process which is far stricter and typically requires manufacturers to conduct trials in people to demonstrate safety and effectiveness.

The exceptions are in the case where the devise is exempt from a review or then in the case of a class III devise that was on the market before the date that legislation establishing three device classes was enacted i.e. before May, 28, 1976. Those falling under either of these two categories can be cleared through the 510(k) process.

The GAO report states that under the Safe Medical Devices Act of 1990 the FDA was required to either reclassify those pre-1976 class III devices as class I or class II devices or mandate that they obtain approval through the PMA process neither of which has been done 20 years later.

According to the report "GAO recommends that FDA expeditiously take steps to issue regulations" for these types of devices, and the Department of Health and Human Services, which oversees the agency, agrees.

Susan Alpert, ex director of the evaluation office in the FDA division that regulates devices in the 1990’s and currently chief regulatory officer for Medtronic, a device manufacturer said the agency did not act on the 20 pre-1976 types of devices due to a lack of resources, adding that the FDA doesn't have a "huge safety concern" about these types of devices.

FDA spokeswoman Karen Reilly said "we're considering legal and procedural options" to reclassify the 20 device types or require that they submit to the PMA process.