FDA Doubles Down on the Least  Burdensome Approach to Approval 

In his response to a GAO report that FDA needs to evaluate appropriate implementation of the least burdensome requirements of the 21st Century Cures Act, the FDA Commissioner announced that FDA has already trained more than 90 percent of its reviewers in CDRH in least burdensome requirements for new medical device approval decisions, and that similar practices are being aggressively implemented for drugs and biologics as well. FDA encourages manufactures to increase the use of “real world data” gathered as part of clinical care, such as electronic health records and patient registries in support of market approval applications. The current policy is to take a total life cycle approach to device regulation that includes pre-market as well as post-market data collection, and the use of real world data to inform on the benefits and risks of devices. FDA plans to internally audit its staff in the center for devices in June of this year to evaluate the application of the least burdensome approach. These audits will be conducted periodically to assure that the policies are being followed. In addition to the least burdensome approach to new device approval, FDA has also used enforcement discretion for low-risk products such as general wellness devices, diagnostic products, and medical software. The application of this approach to drugs and biologics is not as clearly defined. While FDA has implemented programs that leverage the least burdensome highly collaborative regulatory approaches to special products such as gene therapy, regenerative medicine, and 3D products, the policy seemingly is not yet widely used in the centers for drug and biologics. The enforcement discretion policies however have been actively used in drugs a biologics as well for example with FDA’s policy towards stem cell clinics, and alternative medicines. Overall, FDA seems to take the least burdensome approach to regulation as an agency-wide holistic principle rather than few selected areas which should welcomed by industry and consumers alike.