The Voluntary Improvement Program for Medical Devices
The Voluntary Improvement Program (VIP) is an optional program from the Medical Device Innovation Consortium (MDIC). By evaluating the capability and performance of a medical device manufacturer's practices using third-party appraisals, the program can enhance the quality of medical devices.
As the number of successful cases steadily increases, the MDIC program activities and its operations may gradually transition into a permanent program. The US FDA is hence planning to further support the program and intends to give it a new title: "Case for Quality Voluntary Improvement Program (CfQVIP)".
The stated goal and ambition is to "focus on high-quality products which will better protect and promote public health.” In order to achieve this, the US FDA is working closely with the industry, healthcare providers, and patients to get a sufficient amount of feedback to build an effective program, respectively. Ultimately, the CfQVIP is based on the experience of the VIP, and the CfQ Pilot Program, which are being combined for the purpose of establishing the most effective and rewarding method.
Voluntary Improvement Program (VIP) Opportunities for Medical Manufacturers:
Participating VIP manufacturers must agree to share some of the results of their process appraisals with the FDA. While FDA will do the site visits, appraisers will not do the regulatory inspection. Ultimately, the main purpose of the VIP program is to share experiences only.
The Benefits of the VIP Program include:
● The VIP program represents an opportunity to get to know FDA’s considerations at an early stage: Although VIP appraisals are not regulatory requirements, the FDA may consider inspection results of risks. The participants are thus aware of certain aspects and potential issues that FDA is considering, before they apply for the device application.
● It further is an opportunity to modify submission to change notices of manufacture procedure methods/site supplements/modules: As VIP participants may be aware of FDA’s considerations, they can therefore timely modify and resolve these issues.
Currently, the FDA only provides the draft of the "Voluntary Medical Device Manufacturing and Product Quality Pilot Program" The program will be open for public comments for 60 days and subsequently a modified version of the guidance will be published.
- Voluntary Medical Device Manufacturing and Product Quality Pilot Program
- Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program