As medical device imports into the U.S. continue to grow at a 20% annual pace, CDRH believes it is making progress in its decades-long battle to get on top of the burgeoning foreign inspections the law requires it to do—it’s “outsourcing them” through its new Single Audit Program.
In collaboration with CDRH’s counterpart regulatory agencies in Canada, Australia, and Brazil, this program was described by CDRH Office of Compliance director Steven Silverman in September as having the potential to cover all the inspection bases for multiple regulatory agencies. Addressing a session at a joint FDA–Parenteral Drug Association conference in Baltimore, Silverman acknowledged that “Realistically, we don't have the resources to be on site abroad in the same way we can domestically.”
Unlike other approaches FDA has experimented with over the years in foreign inspections for drugs, devices, and other products, the Single Audit Program is a joint effort by the four partners to conduct a single inspection that satisfies all of their needs. This would presumably get over legal issues in simply adopting a foreign country’s inspection as if it were an FDA inspection.
“If successful,” Silverman said, “we then have a basis for significantly multiplying our reach because it is not just about FDA investigators conducting foreign inspections, it’s also about expanding the scope of participating regulatory authorities and investigators.”
The Single Audit Program would not be available for a company that has a long history of many deficiencies, Silverman said. “We will always rely on agency staff and there will always be firms that require our expertise for review and analysis, but we need to broaden the pool of intelligence that we have available to us, and we think that the single audit program is a key mechanism in that regard.”
While this is a relatively new initiative, Silverman said that CDRH is making headway. “In the past year, we have conducted a number of accreditation audits of third-party inspectors, including some audits where we were on-site evaluating how they conducted the inspection. This is very promising and there is more work that needs to be done. And because these are ongoing discussions, I am limited in what I can say except to say this is a high priority for us and will continue to be.”
Silverman’s presentation also addressed ongoing improvements to the Warning and untitled letter process. “We look at these as a key mechanism to achieve voluntary compliance,” he said. “When Warning Letters and untitled letters are issued late and months after an inspection their impact is diminished. We realized we had some internal process challenges that were hampering our on-time review and clearance of the letters. So we convened a cross-office working group that identified 60 factors that have an impact on our ability to engage in a timely review and classification.
“This is a relatively recent process but we have already identified a number of steps that we can take in response to clear out some of the confusing factors that limit our performance. And we have seen gains in times of our timely review and clearance. We will never hit the 100% mark because there will always be outliers, but we owe it to industry and patients to be timely in our determinations and this will continue to be an area of significant focus.”