Devices

Device Guidance on Voluntary Improvement Program

FDA has posted a draft guidance entitled “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program.” The document describes FDA policy on the agency’s participation in the Voluntary Improvement Program (VIP), which is run by the Medical Device Innovation Consortium and uses third-party appraisals to evaluate device makers’ quality practices. “The VIP builds on the framework piloted through FDA’s 2018 Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program and incorporates some of the successes and learnings from the pilot,” explains the agency.

The VIP is a quality maturity appraisal and continuous improvement program, which was developed to improve medical device production and quality, the guidance says. Appraisers assess a firm’s practices against a set of best practices under the pilot. “Then, based on the third-party appraiser’s evaluation of a participant’s practices, the VIP identifies the firm’s strengths and potential opportunities for improvement,” it says, adding that the program allows the third-party appraiser to share some of that information with FDA.

The agency notes that the site visit/analysis is not intended to be a regulatory inspection or an audit, and they do not assess the firm’s compliance with applicable regulatory standards. However, participating manufacturing sites who demonstrate sustained capability and performance, or improvements in the appraisal results, may benefit from a more positive rating in FDA’s risk-based inspection planning. Additionally, FDA says it expects to offer participating manufacturing sites the opportunity to submit 30-Day Change Notices for modifications to manufacturing procedures or methods of manufacture using a modified submission format, among other incentives.

To view the guidance, click here.

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