The FDA’s commissioner Scott Gottlieb made several large announcements this week that reflect a continued drive to reduce regulatory burden to industry to foster an environment for innovation and allowing greater speed to market for regulated products.
Earlier in the week the Agency announced its intentions to publish a guidance to “modernize” the 510(k) process: “FDA intends to publish a draft guidance, again in early 2018, setting forth factors that the agency may consider when assessing acceptable uncertainty. The guidance will outline how certain issues could be ultimately resolved in the post-market setting, rather than the pre-market setting, to allow patients to gain faster access to potentially life-saving devices, when appropriate. Under this form of more progressive review, FDA will outline how it makes judgments about when it’s appropriate to place greater reliance on post-market data in order to facilitate access to certain innovation, or when the agency needs to rely more on pre-market data collection because of certain issues related to a particular product or how it may be used.”
Towards the end of the week, the Agency further made clear their intention to drive a least burdensome approach: Least burdensome approach presses forward: “The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “The Least Burdensome Provisions: Concept and Principles” FDA utilizes a least burdensome approach to medical device regulation to eliminate unnecessary burdens that may delay the marketing of beneficial new products, while maintaining the statutory requirements for clearance and approval.”
These announcements, along with publication of the Agency’s policy goals for 2018, and a list of guidance documents the FDA expects to address in 2018, reflect an FDA focused on, as Dr. Gottlieb says, “more flexible regulatory approaches in order to make sure advances in care can reach patients.”
Postscript – 22DEC2017 – additionally the Agency continued to provide demonstration of being more flexible in their regulatory approach by announcing a proposed shift to allow MDRs to be reported quarterly rather than in 30 days in certain cases. https://s3.amazonaws.com/public-inspection.federalregister.gov/2017-27650.pdf
