The U.S. Food and drug administration director Scott Gottlieb said on Thursday that the agency has received and inspected nearly 600 single audit plans for medical devices from foreign regulatory partners as the number of participating production bases has soared since last year.
William Maisel, director of the FDA’s office of equipment evaluation, told lawyers, consultants and others at the Washington conference that a single audit program will be a constant focus next year. FDA and its global counterparts will deploy information sharing systems to expand the use of shared audit reports and gradually require compliance with common international standards.
As of the third quarter of 2018, a total of 2629 websites had been added, up from 777 at the end of 2017. Canada, Germany, Japan, China and the UK are among the participating countries. Since the first meeting of the international forum of medical device regulators in 2012, global regulators have been moving towards unified inspection. Maisel pointed out that the FDA’s goal is to issue the proposed rules in 2019, detailing how it intends to align institutional quality system regulations for medical devices with international standards.
The idea was first put forward in the unified agenda for spring 2018, initially targeting April 2019, but the latest autumn update has delayed the expected publication date to September 2019. The proposed rules will replace the current consensus standard for medical device manufacturing, ISO 13485:2016. “These amendments are designed to reduce the compliance and record keeping burden of equipment manufacturers by harmonizing domestic and international requirements,” the unified agenda noted.
Maisel believes that mdsap should continue to grow, calling it a “real opportunity.”. He pointed out that up to now, half of mdsap inspections have been conducted in the United States, but Canada recently required mdsap inspections for all companies. “We see this as a real opportunity for the agency to make better use of its resources and for the company to be able to conduct a single inspection to meet multiple jurisdictions,” Maisel said.
Gottlieb also praised the FDA’s new authority under the FDA safety and innovation act of 2012 and the FDA reauthorization act of 2017 to choose when to inspect certain devices rather than at regular intervals. The Commissioner argued that previous requirements “made it difficult for the FDA to prioritize inspections based on the risks they raised.”
“Congress removed the requirements for drugs and category 2 and Category 3 equipment, respectively,” Gottlieb said. “This allows FDA to use risk-based standards to set inspection plans, such as compliance history and inherent risks of products.” According to Gottlieb and Maisel, if problems are found, the FDA is trying to share inspection results with device manufacturers more quickly.
“Sometimes, when we have early and decisive conversations, we can achieve compliance faster. In many cases, it allows us to get rid of controversial, often lengthy letter exchanges and law enforcement operations, “Gottlieb said.