Voluntary Compliance Pilot Offers Chance to Avoid Inspection

December 27, 2013

The FDA will soon begin identifying candidates for a pilot program whereby manufacturers can opt to self-identify and correct possible regulatory violations and avoid FDA inspection. But it’s not clear how wide a net the agency will cast to attract applicants to the program or how interested manufacturers will be in participating.

The Voluntary Compliance Improvement Program pilot is a joint effort of the Center for Devices and Radiological Health and the FDA’s Office of Regulatory Affairs. Alonza Cruse, director of the Los Angeles ORA district office, was a principal driver of the initiative, said agency spokeswoman Jennifer Rodriguez. Plans for the pilot were included in the FDA’s 2013 Strategic Priorities report.

The initial response to the program has been positive, Rodriguez said. “Manufacturers and the FDA share the goal of identifying strategies to promote device quality.” She said the agency plans to start contacting potential participants soon and hopes to begin reviewing applications early next year. Only three to five manufacturers will be accepted into the program.

According to the FDA, the pilot will proceed in four phases: problem, statement declaration and correction phase; root cause plan; corrective action; and verification/evidence of effectiveness and close-out.

AdvaMed spokesman Mark Brager said the trade group is still reviewing the program and waiting for feedback from its members.

But Beth Bierman, a partner in Morgan, Lewis & Bockius’ FDA law practice, thinks manufacturers may have reservations about disclosing possible regulatory lapses. “I would imagine that companies are not jumping to volunteer before they see some history on it,” she said. Plus, the program will only be open to companies that are preselected by the agency, she said. Companies with violations that “raise imminent public health concerns” won’t be allowed to participate, according to the FDA’s website.

While participating in the pilot could help manufacturers avoid an inspection and Form 483 observations, some devicemakers may prefer to spare the time and expense of retaining an independent expert and following the program’s four phases, Bierman observed. “If you’re a company that has a pretty good quality system in place and you anticipate that when you are inspected you will only get a few 483 observations, or manageable ones, then having to retain an independent consultant and go through this very structured program could subject you to much more rigorous review than you would undergo in the normal inspection,” she said.

According to the FDA’s website, a firm that participates in the program could still face inspection and regulatory action if it fails to meet its commitments or if the agency and company disagree about any of the results during the program.

Everyone wants to succeed. Participating in an FDA compliance program that would exempt you from inspections may get you there. Meanwhile, read up on how to assure your success, with the FDA Complete Response Letter Analysis: How 51 Companies Turned Failure to Success.