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FDA Promotes Voluntarily Correcting Violations with New Program

FDA recently announced details of a new pilot program that will allow medical device companies to voluntarily identify and correct regulatory violations rather than undergo FDA inspection. The Voluntary Compliance Improvement Program (VCIP) was launched in an effort to apply innovative strategies that promote medical device quality.

FDA will identify eligible participants through its 2014 inspection work plan and ultimately choose three to five applicants. Manufacturers with violations that raise imminent public health concerns are barred from participating.

The program’s proposed benefits include the manufacturers’ ability to self-identify and correct deficiencies instead of undergoing an inspection that could result in regulatory action. Facilities will not be subject to routine surveillance inspection while the program is underway, as well as two years after successful completion of the program. Another proposed benefit is that FDA will expedite review of export certificate requests and prioritize device and pre-amendment determination requests.

FDA has outlined the VCIP’s phases along with other participation requirements. An obvious risk is that if a manufacturer does not meet the guidelines, it can be removed from the pilot and undergo inspection, possibly leading to regulatory action.

What potential risks could arise? How else can manufacturers potentially benefit?
If selected, will you participate in the pilot?


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