Comments on Medical Device VIP Program Draft Guidance

Medtronic says it appreciates FDA's continued support for the Case for Quality Voluntary Improvement Program (VIP) with its “innovative approaches to facilitate continuous improvement above and beyond compliance.” Commenting on an agency draft guidance, Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program, Medtronic says it has already seen the positive impact of VIP at its participating sites. The company also provides line-by-line specific comments.

The National Center for Health Research, a nonprofit think tank that says it conducts, analyzes, and scrutinizes research, policies, and programs on a range of health and safety issues, complains that this is the first opportunity it has been given to comment on the proposal. The center says it has many concerns about the proposed program and cites three:

• FDA staff are vetted to reduce conflicts of interest but third-party appraisers have an inherent conflict of interest, to please the companies that use their services;
• the program seems to give qualifying manufacturers the option of revising their manufacturing practices and the information about their practices that they are required to submit to FDA, which the center says is not in the best interest of patients, consumers, or public health; and
• FDA programs are often inadequate to meet the needs of patients and consumers who rely on medical devices and any program worth doing should not be voluntary because it can lead to biased results, lack of enforcement, and a lack of penalties for failing to comply with voluntary requests.

“The proposed program is one of several recent proposals and programs that reduces the burden on industry and FDA staff by lowering the standards for medical devices,” the letter says. “Moreover, it sets a dangerous precedent of outsourcing ‘appraisers’ to make judgments about which companies are eligible for special treatment. Unlike third-party appraisers, FDA staff would be unbiased and knowledgeable, with an understanding of FDA’s mission as a public health agency.”

Cook Group says it supports the continuation of the VIP program for eligible device manufacturers. “Although it is specifically stated in the draft guidance that FDA retains its inspectional authorities covered in the risk-based inspection model,” the letter says, “both FDA and industry could benefit significantly from the strengths and potential benefits of a performance-based maturity model for quality in a manufacturing operation.” The company gives information on its experience as a VIP site and also has specific recommendations for the future.

Boston Scientific commented that the program should avoid specifying that appraisals be required annually and instead leave it open to the possibility that the frequency is tailored as companies remain active in the program over several years.

Line-by-line specific comments were provided by Edwards Lifesciences and Becton Dickinson.