FDA Proposes More Stringent Medical Device Approval Rules

Federal regulators are planning to strengthen a fast-track medical device approval process, which critics say has let dangerous products slip through the cracks. 

Earlier this week, a working group within the FDA released a preliminary evaluation of a program that allows medical device approval to be expedited if the device has “substantial equivalence” to something already on the market. The evaluation included a list of recommendations for changes to the program to make it more effective.

According to the report and critics outside the agency, the term “substantial equivalence” has not been consistently interpreted by FDA medical device reviewers. Over time, the report found, the 510(k) standard began to be applied to a wider and wider array of medical devices which had less and less in common with devices that had already been approved. The report also finds that devices have been approved under the program that were patterned after products that had been pulled from the market due to safety reasons.

The working group recommends a stricter and consistent interpretation of “substantial equivalence.” It also recommended that the Center for Devices and Radiological Health (CDRH), which oversees the 510(k) program, set forth a list of factors that would disqualify a medical device from counting as a predicate; a design upon which other devices can be based for fast approval.

The working group also determined that CDRH needs to work harder to obtain sufficient information about the devices that it approves, preferably by getting device manufacturers to provide a wealth of information up front at the beginning of the process. However, the group notes that the FDA needs the resources and technology, as well as the training to make all of the proposed recommendations work well, something that appears to currently be lacking.

Some lawmakers and agency officials have suggested that the FDA needs more resources to handle medical device approval. In 2006, the FDA noted that it was overwhelmed by the volume of submitted reports on medical device-related risks and does not review those reports in a timely or routine manner. FDA indicated that it has so far been unsuccessful in alleviating the backlog.

A study by the Government Accountability Office (GAO) released in June 2009 found significant shortcomings in FDA medical device approval procedures, and a heavy reliance on the 510(k) process. The GAO report identifies gaps in the FDA reviewing process, deficiencies in the agency’s postmarket surveillance, and also found that FDA has not kept up with regular inspections of medical device manufacturing facilities. Many devices which should be put through the more stringent premarket approval process are put through the premarket notification process instead, the GAO found.

Last year, lawmakers introduced the Medical Device Safety Act of 2009, which seeks to overturn a 2008 Supreme Court decision in Riegel vs. Medtronic. In that case, the Supreme Court held that medical device lawsuits against manufacturers for injuries caused by defective products may be barred if the device was approved by the FDA. However, the bill has not moved forward.

Recent lawsuits over the Medtronic Sprint Fidelis defibrillator lead, which was recalled in October 2007, have been used as an example of the need for legislation to restore individuals ability to pursue lawsuits against medical device manufacturers. The Medtronic defibrillator lead recall was issued after they were implanted in more than 250,000 patients, when they were found to be defective and prone to fracture or break.

Although evidence suggests that Medtronic was aware of the reported lead problems for months before the recall was issued, an order was issued in January by a federal judge dismissing all of the Medtronic lead lawsuits based on the Supreme Court ruling in Riegel.