FDA recently announced a potential massive overhaul to its Medical Device regulations. Specifically, the agency intends to “harmonize and modernize” its medical device Quality System Regulation (21 C.F.R. Part 820) with an international consensus standard for medical device manufacturing (ISO 13485).
The rulemaking entitled “Harmonizing and Modernizing Regulation of Medical Device Quality Systems” appears on FDA’s regulatory agenda. The proposed rulemaking is not anticipated to be issued until April 2019, which is subject to change after review and approval by the Office of Budget and Management. The regulatory agenda provides that:
FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation.
Commissioner Gottlieb also mentioned the proposal in a recent blog:
As part of our efforts to continue to ensure efficiency of existing regulations, we will be taking another step to modernize medical device regulation, by proposing a new regulation to replace certain aspects of existing Quality System regulations with specifications of an international consensus standard for medical device manufactures (ISO). This rule, if finalized, will harmonize domestic and international requirements and modernize the regulation to make it more efficient for manufacturers of medical devices seeking to sell their products globally, while also continuing to ensure they adhere to high, internationally-accepted quality systems.
Although the differences between Part 820 and ISO 13485 are not substantial in most respects, it is not yet clear on how FDA plans to “harmonize and modernize” the regulation. Commissioner’s statement indicates that only “certain aspects” of Part 820 will be replaced with ISO 13485. We should know more in the coming months as FDA intends to provide more on its proposal as it engages with stakeholders. FDA is anticipated to speak on this topic at an Association for the Advancement of Medical Instrumentation conference next month. We are monitoring this initiative and will post more as we learn more from the FDA.