FDA Reveals Voluntary Medical Device Compliance Pilot Program

Earlier this week, the Food & Drug Administration (FDA) revealed the pilot of the Voluntary Compliance Improvement Program (VCIP) of FDA’s Center for Devices and Radiological Health (CDRH) and Office of Regulatory Affairs’ (ORA). The VCIP will allow some medical device manufacturers to voluntarily determine and correct potential regulatory violations rather than undergo FDA inspection. The pilot program will allow medical device manufacturers to apply to participate, and the pilot program will select three to five manufacturers to participate.

Via a 2014 inspection work plan, the CDRH and ORA will review all applications and will not accept applicants that have violations that raise imminent public health concerns. To participate, device manufacturers must demonstrate the ability to identify problems, analyze causes, and create appropriate corrective actions. If selected, participants will need to retain an outside expert who will be responsible for assessing the participants’ manufacturing and quality assurance systems and verifying that the participants meet program requirements. If a participant does not meet VCIP requirements, or if the FDA and the firm disagree about any of the results during the program, then the firm may be forced to undergo FDA inspection – which could lead to regulatory action. Similarly, if a participant chooses to end its participation in the VCIP, it will be subject to FDA inspection and any resulting regulatory action.

Perhaps the greatest benefit to medical device manufacturers that participate in the VCIP is that their facilities will not be subject to routine surveillance inspection while they are participating in the program. As an added incentive, this exemption from routine inspection by the FDA will extend for two years after participants complete the program. The FDA will expedite the review of export certificate requests and prioritize device and pre-amendment determination requests for program participants. While participants will face the cost of retaining an outside expert for monitoring their self-policing program, those costs may be worth these incentives.