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According to reports, the U.S. Food and Drug Administration’s (FDA) approval rate for high-risk medical devices submitted through the FDA’s Premarket Approval (PMA) process increased to 98% during the last fiscal year, which represents a 15-year high and almost 30% percent increase over 2012.
The PMA provides for the FDA’s scientific and regulatory review of medical devices, such as hip and knee implants, to evaluate their safety and effectiveness prior to going to market. The FDA also provides for manufacturers to use its 510(k) clearance process to get medical devices approved and to the market quicker. This expedited process only requires that manufacturers provide product and performance information about the medical devices after their sale to the public, with no testing or clinical trials beforehand, so long as a medical device is substantially similar to generally successful medical devices already on the market.
The FDA also reported dramatic drops in the average time for determinations of PMA and 510(k) applications. Average FDA decision times decreased from 432 days (2013) to a 14-year low of 262 days (2014) for PMAs, and from 126 days (2014) to a 10-year low of 95 days (2015). The approval rate for lower-risk devices also increased to 85% for 510(k) applications, the FDA’s highest approval rate since 2010.
These dramatic increases largely result from legislative changes via passage of the 2012 FDA Safety and Innovation Act (FDASIA), which was influenced by the medical device manufacturing lobby. Though the hope is that these increased approval times will not sacrifice the quality and integrity of medical devices making it to market, these regulatory changes may prompt new investment by U.S. medical device manufacturers who favor Europe’s less stringent regulatory approval processes.
If you or a family member have suffered and injury from a medical device, or have had revision surgery to remove and replace a defective medical device implant, you and/or your family member may be entitled to money damages.