The FDA is pushing device manufacturers to go beyond meeting baseline regulatory guidelines through its Case for Quality initiative, the head of the FDA's device arm (CDRH), Dr. Jeffrey Shuren, wrote in a post on the agency's blog.
Since the launch of the initiative in 2011, the "FDA has continued to observe that the percentage of inspections calling for official action by FDA has remained static, with the same issues recurring frequently year after year. Given this observation, in addition to FDA inspecting device firms on a regular basis, we are thinking about other ways to support quality beyond inspections and traditional regulatory approaches," Shuren wrote, along with Dr. Howard Sklamberg, the FDA's deputy commissioner for global regulatory operations and policy, and Melinda Plaisier, associate commissioner for regulatory affairs.
The recently FDA-piloted inspections that featured a particular focus on the quality of batteries within implantable devices, providing a concrete example of the new approach
It demonstrates the FDA's increased focus on quality and stakeholder engagement.
The pilot within the scope of a traditional inspection was more technical in nature and focused on area deemed critical to quality. FDA inspectors "brought out engineering notebooks vs. compliance structured documents," one firm said, according to an FDA review of the program.
Following the inspection, the FDA asked the firms questions about their batteries like, "What are the three most critical factors that you consider when choosing a supplier of batteries?"
Overall, all participating firms said they were satisfied with the pilot, and that it promoted interaction with the agency, but none said it changed internal practices or discussion in management.
And in August, the FDA said it is looking for participants in a pilot program that would involve quarterly reporting of medical device malfunctions.
Data transparency is another crucial part of the Case for Quality initiative, is promoted by the launch of OpenFDA.gov, the blog post said.
Although not a part of the Case for Quality initiative, the device arm is also piloting the Medical Device Single Audit Program to coordinate manufacturing facility inspections across 5 countries by utilizing private inspectors.
The program is not securing much participation from industry, much to the chagrin of the agency, which issued a call for additional facilities to participate in September. At least one member country of the international initiative is considering making the program mandatory in the future.
Few firms participated in two previous attempts at international standardization of inspections because of concerns that the FDA could perform a full audit if the joint inspection revealed problems, according to former Department of Commerce official Jeffrey Gren, the president of Gren International Health & Trade Consulting.
- read the blog post