The FDA Publishes Three-Part Final Guidance on ASCA Pilot Program

In Sept. 2019, the U.S. Food and Drug Administration (FDA) Center for Device and Radiological Health (CDRH) introduced the Accreditation Scheme for Conformity Assessment (ASCA) Pilot.1 The program was set up to foster an accredited conformity assessment arrangement between medical device manufacturers, accreditation bodies and testing laboratories. After receiving comments from the public and industry stakeholders, the FDA released its final guidance for the ASCA Pilot in September 2020._²

The Purpose of the ASCA Pilot

In a nutshell, the FDA intends for the ASCA Pilot to use accredited, third-party testing laboratories to assess the declaration of conformity (DOC) provided by medical device manufacturers in their premarket submissions. These assessments will determine the company’s adherence to the agency’s consensus standards for safety, performance and biocompatibility.

The voluntary pilot program is designed to help make medical device and in vitro diagnostic product (IVD) premarket reviews more consistent and efficient. The agency also intends for the program to reduce the regulatory burden on device manufacturers by increasing product reviewers’ trust in medical device testing.

ASCA Pilot Final Guidance

The final guidance for the ASCA Pilot is considerably more comprehensive than the original draft. One notable variance is it includes an expanded section on the policies and processes involved in testing products. For example, guidelines regarding the organizational structure, environmental conditions and resources of the testing laboratories include:

• Ensuring staff is qualified and continually trained on methods to conduct testing within the scope of the regulations and standards.
• Implementing procedures for governing the development, maintenance and use of tests.
• Maintaining testing equipment to ensure it remains in proper working order according to the accreditation requirements.
• Setting up procedures for identifying testing errors caused by incorrect calibration or operation of equipment that could affect the accuracy and reliability of testing results.
• Documenting and reporting all required information as detailed in ISO/IEC 17025.³

The FDA’s final guidance for the ASCA Pilot is dispersed across three guidance documents:

• Goals and implementation of ASCA Pilot.
• Basic safety and essential performance standards.
• Biocompatibility testing of medical devices.

This article highlights aspects of each guidance that apply to medical device manufacturers and accredited testing laboratories participating in the ASCA Pilot.

#1: ASCA Pilot – Goals and Implementation

When the FDA first set up the ASCA Pilot in Sept. 2019, the agency set goals for how the program will support its ongoing efforts to use its scientific resources effectively and efficiently to protect and promote public health.

• Enhance confidence in medical device testing – Includes application processes and periodic audits of ASCA-recognized accreditation bodies to ensure they meet the criteria specified by the FDA.
• Promote consistency and predictability in the premarket review process – The FDA’s commitment to clearly communicate expectations for how results from ASCA-accredited testing laboratories will be included and reviewed in premarket submissions.
• Encourage effective use of FDA resources – Enlisting third-party organizations to participate in assessing the declaration of conformity (DOC) submissions from manufacturers allows the FDA to devote scientific and regulatory resources to other pertinent priorities.
• Enhance regulatory efficiency – The FDA expects that the application process, periodic audits and clear communication among participants in the ASCA Pilot will decrease the need for additional information regarding testing methodologies, which will help speed up the submission process.
• Support international harmonization – In developing the ASCA Pilot, the FDA used elements from international conformity assessment standards in the ISO/IEC 17000 series. In addition, most of the FDA-recognized consensus standards and test methods selected for the ASCA Pilot are international consensus standards.

Medical device manufacturers can use testing performed by an ASCA-accredited testing laboratory to support their premarket submission as long as the laboratory uses an FDA-recognized consensus standard. ⁴

#2: Basic Safety and Essential Performance Standards

This segment of the guidance addresses the responsibilities of accredited laboratories in developing test plans and procedures. For example, tests should be project-specific and include documentation of test details the FDA has itemized in the guidance, such as:

• Test identification information, including title, document number, revision, and effective date.
• Specific test equipment required.
• Warning/caution statements to alert operators of potential hazards.
• Normal and/or unusual ambient conditions, including tolerances for tests.
• Test data to be obtained and recorded.
• Objective acceptance criteria.

The guidance includes guidelines for inspecting the manufacturer’s risk management file to obtain objective evidence. Laboratories must also provide a list of all documents examined during the inspection.⁵

#3 Biocompatibility Testing of Medical Devices

Finally, regulatory bodies are committed to the protection of patient safety. That said, biocompatibility, which involves screening new medical devices for the possibility of patients experiencing adverse reactions, is a pivotal component of the ASCA Pilot.

To comply with the biocompatibility requirements, participant accredited bodies must conform to guidelines in the ISO/IEC 17025 standard, which explains how laboratories need to demonstrate that they operate competently and generate valid results. ⁶

In addition, this segment of the guidance states that “all testing should be conducted considering the recommendations in the CDRH Biocompatibility policy as described in the FDA’s guidance ‘Use of International Standard ISO 10993-1.’”7 The agency created this guidance to assist medical device manufacturers with preparing premarket applications for devices that have direct or indirect contact with the human body. It advises manufacturers on using risk-based approaches to determine if biocompatibility is needed.

The ASCA Pilot is voluntary. Device manufacturers that choose to use an ASCA-accredited testing laboratory to conduct testing are responsible for including the appropriate information regarding device testing in their premarket submissions. The FDA is still building the ASCA Pilot. As with other pilot programs, the agency will determine at a future date if more regulations, legislation and public input will be needed before transitioning the ASCA Pilot to a permanent program.

References

1. The Accreditation Scheme for Conformity Assessment Pilot Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff; Availability, Food and Drug Administration, Sept. 23, 2019, https://www.federalregister.gov/documents/2019/09/23/2019-20543/the-accreditation-scheme-for-conformity-assessment-pilot-program-draft-guidance-for-industry
2. “The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program,” U.S. Food and Drug Administration (FDA), Sept. 2020, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/accreditation-scheme-conformity-assessment-asca-pilot-program.
3. “ISO/IEC 17025 Testing and Calibration Laboratories,” International Organization for Standardization (ISO), https://www.iso.org/ISO-IEC-17025-testing-and-calibration-laboratories.html.
4. “The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program,” U.S. Food and Drug Administration (FDA), Sept. 25, 2020, https://www.fda.gov/media/130901/download.
5. “Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program,” U.S. Food and Drug Administration (FDA), Sept. 25, 2020, https://www.fda.gov/media/142385/download.
6. “Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program,” U.S. Food and Drug Administration, Sept. 25, 2020, https://www.fda.gov/media/142388/download.
7. “Use of International Standard ISO 10993-1, ‘Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process,’” U.S. Food and Drug Administration, Sept. 2020, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and
   

   ---