Our October 2019 webinar highlighted key areas of change related to the FDA.
This webinar will highlight key areas of change related to the FDA and actions medical device manufactures might consider taking in response to these updates.
We’ll cover the following topics:
1. FDA’s Breakthrough Devices Program, an outcome of the Cures Act and the 2017 Reauthorization Act, became final in December 2018. Because the information is considered confidential, the public information on devices that have been granted that status is limited but FDA has said that over 100 devices have been granted breakthrough status. We will share our experience with the program and how it impacts FDA interactions.
2. Medical Device Development Tools (MDDT)— Do you have an awesome evaluation tool that you think negates the need for clinical studies on your device? We will take a look at the little utilized MDDT option to qualify your tool or utilize another person’s tool to demonstrate device performance outside of a clinical trial. There have been four tools identified thus far and we’ll describe how you could potentially use them to reduce trial needs, shorten time frames, and more.
3. FDA’s Efforts to Harmonize and Modernize the Quality System Regulation— FDA has announced their intentions to adopt ISO 13485:2016 as the de facto GMP requirements set in lieu of the Quality System Regulation (21 CFR 820). Our former FDA Investigator Jake O’Donnell will discuss the process by which regulations are changed, and his view of the probable impact of the switch to ISO 13485:2016 on medical device manufacturers.
4. FDA Restructuring Process— The FDA Medical Device and Radiological Health community has also been changing organizationally, starting with Program Alignment several years ago, and continuing with the reorganization of CDRH to a structure perceived as more conducive to full life-cycle management of medical devices. Jake O’Donnell will discuss these changes and his views on how they may affect regulated industry.
5. Safety and Performance Based 510(k)— we will address how submissions have been ‘revamped’ with the expansion of an abbreviated pathway called the Safety and Performance Pathway. For devices that qualify (based on indication, technological characteristics, and safety and performance criteria) this pathway will be an option to allow manufacturers to demonstrate that their device is substantially equivalent to a predicate device in a way that is less burdensome, but as least as robust as a traditional 510(k). The safety and performance pathway holds promise to streamline the FDA 510k device process when the device is well established and standards and guidance are available. This feels like another step towards harmonization with the usage of standards instead of requiring side by side testing with the predicate device.