FDA Redoubles MDSAP Recruitment Effort as J&J Shares Its Experience

Speaking at AdvaMed 2015, FDA Associate Director for International Affairs Kim Trautman renewed her call for participants in the International Medical Device Regulator Forum’s single audit pilot program, saying devicemakers have proven reluctant to join.

“Trust me, this is a much more optimal program,” than the current system of multiple inspections devicemakers that do business in multiple countries face. While a Medical Device Single Audit Program inspection might last a couple of days longer than an FDA inspection, at least as much time — if not more — is lost preparing for visits from several regulatory bodies under the current system.

Her plea comes a month after the FDA released a mid-pilot report showing tepid interest among devicemakers in joining the MDSAP pilot. As of July 23, 45 sites had expressed interest in participating in the program; the target for the end of 2016 is 330 (IDDM, Sept. 18).

MDSAP is not going to go away, Trautman promised, adding the pilot will help iron out wrinkles in the single audit concept, and companies can benefit by going through the experience.

Case in point: device giant Johnson & Johnson nominated three of its facilities to participate in the program.

Among the company’s goals in joining the pilot were “what do we want to learn through this process and what is the value that we’re going to bring to the business,” said Karen Parker, senior director of regulatory compliance at J&J.

Parker had tips for those interested in having a single audit, including educating internal teams about MDSAP’s requirements.

Prior to the audit, the J&J sites developed open lines of communication with the auditing agency, which allowed them to determine the logistics and gather proper documentation, Parker noted.

It’s also imperative to have experts on hand — even if they must be accessed remotely — to help complete the audit, she said.

Parker added that the inspection was prescriptive and driven by an IMDRF companion document that helps explain the program. She said the company had to pull different records during inspections at different sites to show each met regulations. It was an “aha moment,” she said.

Trautman said devicemakers should expect the single audit process to get easier as people gain familiarity with it.

Earlier this year, James Hamer, global director of quality assurance and regulatory affairs at Arthrex, a North Naples, Fla., orthopedic surgical supply company, detailed some of his organization’s experiences as the first company to go through a MDSAP audit (IDDM, April 17). He told IDDM that manufacturers planning to participate in the program should enhance their knowledge of Australian and Brazilian regulations, which include fine details. He added that his company will stick with MDSAP audits in the future.— Elizabeth Hollis