The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law on July 9, 2012. It includes the Medical Device User Fee Amendments of 2012 (MDUFA III), which increase user fees in exchange for speeding up the approval process. For some, this hastening of the approval process raises concerns, particularly for those already concerned with preexistent shortcuts, such as the 510(k) approval process.

The Center for Devices and Radiological Health, the department of the FDA responsible for the regulation and review of medical devices, divides medical devices into three classes. Class III devices, including implantable devices, some of which are considered high risk to the patient’s health such as hip replacements, go through one of two approval processes. The premarket approval process is an extensive review including rigorous clinical trials that show the device is safe for use in humans. It is a lengthy, detailed, and expensive process that can take as long as two years and cost as much as $250,000. The other option is the 510(k) approval process.

The 510(k) approval process essentially pre-approves any product deemed “substantially equivalent” to another product already approved for sale. It requires no clinical testing, costs less than $5,000, and takes an average of three to six months to complete. Separate components of a device can be deemed “substantially equivalent” to different approved products, without consideration of the novel combination. What is more, the products the applicants compare theirs to can be ones approved by the 501(k) approval process themselves. This process, considered by some to be a loophole, has led to products being brought to the market that have been found to be dangerous and ultimately recalled, such as the DePuy ASR XL Acetabular system, a hip replacement.

The MDUFA III does include certain performance goals outlined in the Secretary of Health and Human Service’s letter to Congress, some of which pertain to the 510(k) approval process. The Consumers Union, however, warns that the bill does not do enough to strengthen protection for patients.

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