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Struggling with Quality Compliance? This Pilot Study Is for You

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The Medical Device Innovation Consortium is seeking manufacturers to participate in a new pilot study intended to help manufacturers who have had trouble achieving and sustaining quality compliance.

A new pilot program, a spinoff of the existing Case for Quality Program, is now accepting applications from medical device manufacturers who need help with quality compliance.

Launched in July, the new Accelerate Sustainable Capability (ASC) pilot study is intended to help manufacturers who have difficulty achieving and sustaining regulatory compliance receive insight to help them improve product quality and safety; reach quality compliance more efficiently; structure their systems for continuous quality improvement.

Manufacturers interested in participating in the ASC pilot study can apply here through the Medical Device Innovation Consortium (MDIC), a  public-private partnership that works with government and industry stakeholders to improve patient access to innovative medical technologies. The application period will be open until nine sites have been approved for participation.

MDIC said the goal is to test a methodology for providing systemic improvement to enable FDA 483 and/or advisory actions to be closed faster and more sustainably while, at the same time, ensuring objective metrics and residual risk assessments are in place to provide the agency with oversight of product quality throughout the process.

Benefits of participating in the ASC pilot study

MDIC will cover the costs of the Capability Maturity Model Integration appraisal and other activities conducted under the pilot. This includes the development of an action plan that is agreed upon with FDA, and that is intended to address any FDA inspectional observations, concerns communicated in FDA advisory actions, CMMI appraisal gaps, and residual risk assessment concerns.

During the pilot study, FDA intends to forgo planned routine inspections for participating manufacturers. However, the agency said it will continue to conduct “for cause” inspections of such manufacturers as necessary and appropriate. Participants will have the opportunity to complete the improvements to product quality and safety as specified on their action plan.

Additionally, the participating manufacturer may request a Certificate for Foreign Governments, if needed.

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Who should apply for the quality compliance pilot study?

Any medical device manufacturer that wants help in achieving and sustaining quality compliance is encouraged to apply, MDIC noted.

MDIC said these manufacturers must have an established Quality Management System that is in accordance with 21 CFR Part 820.

Interested manufacturers will be considered on a first-come, first-served basis with a preference for manufacturers that meet these test case scenarios:

  • Two (or more) voluntary self-reporting manufacturers: Manufacturers of any size that self-identify major deficiencies with quality compliance as defined in the Compliance Program 7382.845
  • Two (or more) manufacturers that received an FDA 483 during a recent inspection: Manufacturers of any size that have major deficiencies with quality compliance as defined in the Compliance Program 7382.845 observed in inspection but with no advisory action yet issued by FDA.
  • Two (or more) manufacturers for whom FDA has issued an advisory action: Manufacturers of any size with an open warning letter or untitled letter from FDA, or manufacturers with whom FDA has requested a regulatory meeting as defined in chapter 4 and 10 of the Regulatory Procedures Manual.

The pilot will also consider a mix of domestic and foreign manufacturers when possible. MDIC said it seeks participation from a variety of companies and product types (such as Class III, II, I, diagnostics, disposables, and implants).

There is no fee to apply and manufacturers should expect to be notified of their application's status within one to two weeks. Companies wanting more information about the study may contact Alan Baumel, director of MDIC's Case for Quality Program at abaumel@mdic.org.

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