CDRH, ORA Pilot Program Aims to Reduce Inspections

By Jim Dickinson

CDRH and FDA’s field enforcement organization, the Office of Regulatory Affairs, have begun a two-year pilot voluntary compliance improvement program (VCIP) intended to allow medical device companies to voluntarily self-identify and correct possible regulatory violations instead of undergoing an FDA inspection.

“This is for companies that have problems and are at high risk for enforcement action,” CDRH director Jeff Shuren recently explained. “The pilot will allow these companies to identify the problems, do a risk analysis, come up with a remediation plan, and follow that up with a third-party audit. In return, we will not come in to inspect them and therefore not issue a warning letter or take an enforcement action.”

An agency notice elaborates:

“Types of problems identified by these manufacturers may include quality system violations and other problems, such as failure to satisfy device clearance or approval requirements or adverse event reporting requirements. Firms with violations that raise imminent public health concerns—such as a reasonable probability that use of or exposure to a product will cause serious adverse health consequences or death—may not participate in the program.”

The agency says it will identify up to five manufacturers eligible to participate in the pilot through its 2014 inspection work plan and offer them an opportunity to apply rather than undergo inspection. “CDRH and ORA will review all applications and notify all applicants whether they have been accepted into the program,” the agency says.

Pilot participants will be required to retain an outside expert consultant to assess their manufacturing and quality assurance systems and to monitor and certify that they are following program requirements. Also, participating firms must demonstrate their ability to define problems, analyze root causes, create appropriate corrective actions, and verify that the actions taken were effective.

“If a firm does not meet its commitments under the VCIP, or if the FDA and the firm disagree about any of the results during the program, then the firm may be removed from the program and undergo FDA inspection, which could lead to regulatory action,” the agency says. “If a manufacturer ends its participation in the VCIP, it would be subject to FDA inspection and any resulting regulatory action.”

—Jim Dickinson is MD+DI's contributing editor 

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