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By - SebastianFeye

Navigate Medical Device Approvals with the ASCA Program

Recently, FDA authorized and kicked off a new accreditation program bringing to the medical device industry a new option for medical device testing. The FDA’s Accreditation Scheme for Conformity Assessment (ASCA) Program is designed to streamline the premarket approval process for medical devices and is detailed in a draft guidance released by the FDA on September 23, 2024. The ASCA Program is fee based and offers significant advantages for medical device manufacturers seeking faster and more efficient pathways to market if they are willing to select certain testing labs. Here’s what you need to know:

  • The ASCA Program offers potential time and cost savings for device manufacturers seeking premarket authorization (510(k) and PMAs). This program enhances confidence in test results, promotes consistency in the premarket review process, and encourages the effective use of FDA resources, ultimately contributing to regulatory efficiency. This streamlined approach means your device testing is more likely to meet FDA requirements during the initial review, minimizing the potential for costly and time-consuming revisions.
  • The ASCA Program is built on a foundation of internationally recognized standards and frameworks. It incorporates elements from established conformity assessment practices, specifically utilizing ISO/IEC 17025:2017, which outlines general requirements for the competence of testing and calibration laboratories. Testing laboratories accredited under ASCA employ FDA-recognized consensus standards and test methods to evaluate device safety and effectiveness.
  • Collaborate with an ASCA-accredited testing laboratory for your premarket submissions. These specialized labs, assessed by FDA-recognized accreditation bodies, undergo a rigorous evaluation process to ensure they meet the program’s stringent requirements. You can find a list of ASCA-accredited labs on the FDA website. When selecting a lab, review their scope of ASCA Accreditation, which details the specific standards and test methods they are qualified to perform.
  • Understand the significance of the ASCA Declaration of Conformity (DOC) and its role in your premarket submission. An ASCA DOC is a formal statement asserting that your device adheres to the applicable FDA-recognized standards, signifying a higher level of confidence in testing outcomes. It is crucial to provide a comprehensive ASCA DOC, along with a detailed ASCA Summary Test Report from the accredited lab, to support your application.
  • Maintain transparency throughout the testing and submission process. The ASCA Program emphasizes clarity, completeness, and accuracy in all documentation. When compiling your premarket submission, ensure it explicitly differentiates between testing conducted within the framework of the ASCA Program and testing performed outside its defined scope. Provide supporting documentation, including a detailed ASCA Summary Test Report, to substantiate your ASCA DOC and address any concerns raised during the testing phase.

Figure 1 below provides a process flow summarizing the ASCA program, sourced from the FDA ASCA guidance

Figure 1. ASCA Program Process Flow Chart

By understanding and implementing the ASCA Program, medical device manufacturers can navigate the regulatory process more effectively, reduce the likelihood of delays in regulatory reviews, and bring their innovations to market faster. If you or your firm has any regulatory needs or questions regarding a regulatory submission or other regulatory issues, please send us an email at in**@ac*******************.com for a rapid response and quote for the required services.

Recently, FDA has been rejecting entire 510(k) premarket submissions as not substantially equivalent (NSE) due to testing reports provided from labs in India and China, specifically related to Biocompatibility. Along with recent FDA press release about the increase in Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions. FDA is making a broad statement to manufacturers to qualify and scrutinize all third-party data reports and ensure there is no data integrity violations, this further emphasizes the potential benefits of the ASCA program and the criticality of data integrity in all data provided to the FDA.

Source

The Accreditation Scheme for Conformity Assessment (ASCA) Program. FDA Guidance. Draft Document Issued September 23, 2024

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