The question was raised whether the current 510(k) process is ensuring that the medical devices released to the market are safe and effective. The Institute of Medicine (IOM) investigated this question and found that the current 510(k) process is flawed based on its legislative foundation. One of their findings was that when the FDA assesses the substantial equivalence of a device, it does not necessarily require evidence of safety or effectiveness, but rather the product’s safety and effectiveness is assumed based on its similarity to the predicate design. The IOM also found deficiencies in the FDA’s post market surveillance of products. They recommended that the FDA should rather develop an integrated premarket and postmarket regulatory framework that provides assurance of safety and effectiveness throughout the device life cycle.

Any change to the 510(k) process would have implications to medical device development, and initiating a new 510(k) framework would be very significant. The IOM is suggesting that the new framework be based on sound science, so while many companies today are relying on their predicates to prove safety and effectiveness, this new framework would require much more solid evidence, meaning that companies would have to change their strategy and do a lot more work to prove that their new device would be safe and effective. I would imagine this would significantly increase development time and cost for the average medical device manufacturer today.

References:
http://nationalacademies.org/hmd/Reports/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years.aspx
http://nationalacademies.org/hmd/~/media/Files/Report%20Files/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years/510k%20Clearance%20Process%202011%20Report%20Brief.pdf