Dive Brief:
- FDA Commissioner Scott Gottlieb Thursday said that the agency has received and classified almost 600 Medical Device Single Audit Program inspections by foreign regulatory partners, as the number of participating manufacturing sites spiked since last year.
- The single audit program will be an ongoing focus next year, William Maisel, director of FDA's Office of Device Evaluation, told lawyers, consultants and others at a Washington conference. FDA and its global peers will be deploying an information sharing system to expand use of shared audit reports and move towards requiring compliance to a shared international standard.
- Some 2629 sites were cumulatively added as of the third quarter of 2018, up from 777 at the end of 2017. Canada, Germany, Japan, China and the United Kingdom are among participating countries.
Dive Insight:
Global regulators have been moving toward harmonized inspection since the International Medical Device Regulators Forum first met in 2012.
Maisel noted that FDA is aiming to release a proposed rule in 2019 detailing how it intends to align agency quality system regulations for medical devices with international standards.
The idea, first put forward in the Spring 2018 Unified Agenda, originally identified April 2019 as a goal, but the latest fall update pushed the anticipated publication date to September 2019.
The proposed rule will supplant current requirements with the new consensus standard for medical device manufacturing, ISO 13485:2016.
"The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements," the Unified Agenda states.
Maisel argued that MDSAP should continue to grow, calling it a "a real opportunity." He noted that while half of all MDSAP inspections so far have occurred within the U.S., Canada recently required MDSAP inspections for all firms.
"We think this is a real opportunity for the agency to make better use of resources, but also for companies to be able to have a single inspection that can satisfy multiple regulatory jurisdictions," Maisel said.
Gottlieb also praised the new authority FDA gained under the FDA Safety and Innovation Act of 2012 and the FDA Reauthorization Act of 2017 to choose when to inspect certain device establishments instead of being required to inspect at set intervals. The commissioner argued that the previous requirements "made it difficult for FDA to prioritize inspections based on the risk they posed."
"Congress removed that requirement for drugs and Class 2 and 3 devices, respectively," Gottlieb said. "This allows FDA to set its inspection schedule using risk-based criteria such as compliance history and the inherent risk of the product."
FDA is working to share inspection findings more quickly with device manufacturers if problems are detected, according to Gottlieb and Maisel.
"Sometimes we can get to compliance faster when we engage in early and decisive dialogue. In many cases this allows us to shift away from contentious, and often lengthy, letter exchanges and enforcement action," Gottlieb said.