This joint pilot of the FDA’s Center for Devices and Radiological Health (CDRH) and Office of Regulatory Affairs (ORA) is part of FDA’s ongoing effort to apply innovative strategies that promote medical device quality. VCIP differs from the FDA’s traditional oversight model by allowing firms to voluntarily self identify and correct possible regulatory violations instead of undergoing FDA inspection. 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 FDA supports using new approaches to help companies come into compliance. These approaches benefit industry and may decrease the number of inspections that the FDA performs or permit the agency to focus on manufacturers with serious and ongoing problems.
The FDA will identify manufacturers eligible to participate in VCIP through our 2014 inspection work plan and offer them an opportunity to apply to VCIP rather than undergo inspection. For the pilot, the FDA will choose three to five applicants to participate.
CDRH and ORA will review all applications and notify all applicants whether they have been accepted into the program. An acceptance letter will include proposed dates for a meeting to outline FDA’s expectations of program participants, a review of the program phases, and an opportunity for open discussion.
VCIP 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. Firms that participate in the VCIP must demonstrate the 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. If a manufacturer ends its participation in the VCIP, it would be subject to FDA inspection and any resulting regulatory action.
Manufacturers that might otherwise undergo inspection and resulting regulatory action have the opportunity to self-identify and correct deficiencies. Facilities participating in the VCIP will not be subject to routine surveillance inspection while program participation is underway. This exemption will extend for two years after manufacturers successfully complete the program. The FDA will also expedite review of export certificate requests and prioritize device and pre-amendment determination requests from program participants.
The FDA will meet with participants selected for the program at the start of the pilot, which will then proceed in four phases:
Phase 1: Problem Statement, Declaration, Certification and Correction
Phase 2: Root Cause Plan
Phase 3: Corrective Action
Phase 4: Verification/Evidence of Effectiveness and Close-out