FDA reform

Lately, the FDA reform has been in medical device news; things from the departure of the 2nd-in-command at the FDA to the controversial 510(k) approval of the ReGen Meneflex Meniscus implant scaffold.

Partly due to the latter event, the FDA has decided to reform many of it's practices, including a revamp of the 510(k) process. There did not seem to be a very transparent process for 510(k) approval, according to this entry at MDG. Many factors of the process were often dependent on something else.

Another factor was the slow process of approval, which is hindering American innovation. PwC announced a study of healthcare innovation and the United States' score against international players, showing that other countries are catching up. Often times, manufacturers would seek approval in foreign countries because the process would be quicker than through the FDA. FDA will try to speed up the process, but it must be reasonable: “Unnecessary and unreasonable delays for safe and effective products not only hurt innovation, they unfairly punish patients who are relying on America's med-tech entrepreneurs for help.”

The FDA released 25 changes that they plan to implement. The FDA will also collaborate with external experts more. Also, according to the "Innovation Pathway," the FDA plans on trying to speed up the approval process of innovative devices that significantly improve treatments, treat a terminal disease with no treatment, address a public need or address national security (ODTmag). 

Now, we watch for the FDA to implement the changes and see if it can improve American healthcare innovation, while still maintaining patient safety.