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  5. Accelerate Sustainable Capability (ASC) Pilot Study
  1. Quality and Compliance (Medical Devices)

Accelerate Sustainable Capability (ASC) Pilot Study

The Medical Device Innovation Consortium (MDIC) is seeking medical device manufacturers to participate in the Accelerate Sustainable Capability (ASC) pilot study, which was developed in collaboration with the medical device industry, Information Systems Audit and Control Association (ISACA), and U.S. Food and Drug Administration (FDA).

The ASC pilot study is designed to serve as a way to help manufacturers improve performance and compliance. The FDA’s participation in the ASC pilot is an example of continued efforts to ensure patients and providers have access to safe and effective high-quality medical devices.

The pilot will begin accepting applications in July 2020.


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Introduction

CDRH awarded a BAA (Broad Agency Announcement) to MDIC (Medical Device Innovation Consortium) to bring together subject matter experts to collaborate and develop a pilot study that assesses whether struggling manufacturers can benefit from participation in the maturity assessment program to achieve or sustain regulatory compliance; in addition to promoting higher quality products by focusing on activities that will help them continuously improve quality and mature as an organization.

Purpose of the Accelerate Sustainable Capability Pilot Study

The Accelerate Sustainable Capability (ASC) pilot study provides manufacturers with insight that may help them improve product quality and safety, reach compliance quickly, structure their systems for continuous improvement, and identify metrics that will allow FDA to monitor product safety throughout the pilot process.

Benefits of Participating in the ASC Pilot Study

MDIC will cover the costs of the Capability Maturity Model Integration (CMMI) 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, the FDA intends to forgo planned routine inspections for participating manufacturers; however, the agency intends to 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 (CFG), if needed. Participants are encouraged to engage with the CDRH’s  Case for Quality team caseforquality@fda.hhs.gov and the Exports Team within CDRH’s Office of Regulatory Programs (ORP), Division of Establishment Support exportcert@cdrh.fda.gov consistent with the Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices.

Who Can Participate in the ASC Pilot Study

MDIC encourages manufacturers seeking assistance in achieving and sustaining compliance to apply.

MDIC will consider manufacturers that have difficulty sustaining a state of compliance. These manufacturers must have an established Quality Management System (QMS) 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.

  • 2 (or more) voluntary self-reporting manufacturers: Manufacturers of any size that self-identify major deficiencies with the Quality System regulation as defined in the Compliance Program 7382.845
  • 2 (or more) manufacturers that received an FDA 483 during a recent inspection: Manufacturers of any size that have major deficiencies with the Quality System regulation as defined in the Compliance Program 7382.845 observed in inspection but with no advisory action yet issued by the FDA.
  • 2 (or more)  manufacturers for whom the FDA has issued an advisory action: Manufacturers of any size  with an open Warning Letter or Untitled Letter, or manufacturers with whom the 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 seeks participation from a variety of companies and product types (such as Class III, II, I, diagnostics, disposables, and implants).

How to Apply to Participate in the ASC Pilot Study

To learn more about the study or to apply, refer to the ASC pilot study announcement on the MDIC website. There is no fee to apply.

MDIC will notify you of your application’s status within 1-2 weeks.

For more information on applying for the pilot, contact MDIC Case for Quality Program Director, Alan Baumel (abaumel@mdic.org).

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