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  7. Testing Laboratories: How to Participate in ASCA
  1. Division of Standards and Conformity Assessment

Testing Laboratories: How to Participate in ASCA

Update: September 20, 2024

On September 20, 2024, the FDA issued the following draft guidances:

These guidances include updates to the ASCA program based on feedback from public meetings, webinars, stakeholder meetings, and lessons learned internally during the pilot phase.
 
When final, these guidances will replace the three ASCA Pilot guidances published September 25, 2020.

The voluntary Accreditation Scheme for Conformity Assessment (ASCA) Program is intended to enhance confidence in medical device testing, which should streamline conformity assessment elements of device review. Testing laboratories may be accredited in the ASCA Program to perform testing in accordance with ISO/IEC 17025 :2017: General requirements for the competence of testing and calibration laboratories and the ASCA program specifications.

On this page:

Related pages:

Participant Pages
Accreditation bodies

List of ASCA-Recognized Accreditation Bodies
Accreditation Bodies: How to Participate in ASCA
Manufacturers

Manufacturers: How to Participate in ASCA
All participants

Accreditation Scheme for Conformity Assessment (ASCA)
Recognized Consensus Standards Included in ASCA

Overview

ASCA-accredited testing laboratories perform testing in accordance with ISO/IEC 17025 and the ASCA program specifications associated with each eligible standard and test method. A testing laboratory should work with the device manufacturer to develop the test plan.

After testing is complete, the testing laboratory provides the information listed in the relevant ASCA program specifications (including an ASCA Summary Test Report) to the device manufacturer. A testing laboratory may label its testing as having been conducted under the ASCA Program only if the FDA-recognized consensus standards and test methods used were within its scope of ASCA Accreditation at the time of testing.

How to Apply for ASCA Accreditation

Applying for ASCA Accreditation has two steps:

  • Step One: Obtain accreditation from an ASCA-recognized accreditation body, which includes an assessment to both ISO/IEC 17025 and the additional ASCA Program specifications. This is separate from any other accreditation status a testing laboratory may have with that accreditation body.

Note: the ASCA section of the scope of accreditation from the accreditation body should also clearly list any exclusions, such as to specific clauses of a given standard.

  • Step Two: After a testing laboratory has received accreditation from an ASCA-recognized accreditation body to ISO/IEC 17025 and the ASCA specifications, they may apply to the FDA for ASCA Accreditation by submitting documentation by email to ASCA@fda.hhs.gov demonstrating that the applicant organization:
    • Is requesting a scope of ASCA Accreditation consistent with the scope of accreditation provided by an ASCA-recognized accreditation body
    • Has agreed to terms of participation described in Section D of Appendix B of the ASCA program guidance document

Eligibility: Testing laboratories eligible to receive ASCA Accreditation include:

  • Independent testing laboratories, including those based outside the United States
  • Manufacturers' internal (in-house) testing laboratories

Application contents should reflect the following:

  • Administrative information, including the designated points of contact
  • The requested scope of ASCA Accreditation (see the list of ASCA standards); this scope should match a laboratory’s ASCA-specific scope of accreditation from its accreditation body. A testing laboratory may simply reference the ASCA-specific content from the scope of accreditation from a testing laboratory’s accreditation body.
  • Information in support of competence (note that the standards-specific guidance documents contain recommendations for personnel competencies; however, a laboratory is welcome to submit alternate qualifications with justifications for the FDA’s consideration). See Section C of Appendix B in the ASCA Program guidance for details.
  • A signed agreement noting that the applicant agrees to adhere to the terms outlined in Section D of Appendix B in the ASCA program guidance. The applicant should provide this signed agreement as a separate document in their application. This document should reflect the content of Section D of Appendix B in the ASCA Program guidance.

Testing laboratories who are interested in ASCA Accreditation are encouraged to contact the FDA to discuss in greater detail the steps and content needed for a successful application. Send an email to ASCA@fda.hhs.gov to set up a meeting. Biocompatibility labs may also email this address to request a copy of the ASCA Pilot Training Companion Document for Biocompatibility Testing. This document provides greater detail on biocompatibility lab application contents.

For biocompatibility applicants: For testing laboratories including biocompatibility testing methods, compliance with 21 CFR 58 Good Laboratory Practices for Nonclinical Laboratory Studies regulations for biocompatibility testing is needed.

FDA Review of Testing Laboratory Applications

Testing laboratories who apply for ASCA Accreditation should carefully review the appropriate ASCA guidance documents. The FDA intends to review applications for ASCA Accreditation within 60 calendar days and notify the applicant via email of any issues that may preclude ASCA Accreditation so that they may be addressed. When review is complete, the FDA will inform the testing laboratory via email of its decision.

List of Testing Laboratories in the ASCA Program: When the FDA grants ASCA Accreditation to a testing laboratory, the laboratory and its scope of ASCA Accreditation will be posted on the ASCA-Accredited Testing Laboratories list.

Number of Testing Laboratories: There is no limit to the number of testing laboratories who may receive ASCA Accreditation.

How ASCA-Accredited Testing Laboratories and Manufacturers Work Together

The FDA uses a variety of mechanisms to work with ASCA-accredited testing laboratories to ensure they are adequately fulfilling program expectations. ASCA-accredited testing laboratories:

  • Work with client manufacturers to develop test plans. This helps to ensure the appropriate selection and use of recognized consensus standards and test methods.

    Note: For Basic Safety and Essential Performance standards, testing laboratories should communicate with the manufacturer during the development of the test plan regarding any concerns or questions about the “essential performance” of a device as identified by the manufacturer (see the definition of ESSENTIAL PERFORMANCE in the 60601/80601 series of standards). Though the manufacturer has the knowledge to define the essential performance(s) of their device, testing laboratories have expertise in the appropriate testing of these standards and can therefore assist a manufacturer in the definition and verification of their essential performance(s).

  • Consider other relevant FDA guidance in the development of test plans. See the standards’ Supplementary Information Sheets available in the 
    Recognized Consensus Standards database for more information. 

    Note: Supplementary Information Sheets also include information about a “transition period,” where applicable, for when a recognized consensus standard will be replaced by a newly recognized standard. As stated in the FDA guidance document Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, once a transition period has expired, FDA recognition of the replaced standard will be withdrawn and declarations of conformity and test reports using the replaced standard will generally not be accepted to support a premarket submission.

  • Consider the appropriateness of any modifications to methods and/or acceptance criteria from FDA-recognized standards and whether those modifications are permitted in the respective standards. Section XII.B of the ASCA Program guidance and the example Summary Test Reports included in the Appendices in the ASCA standards-specific guidances provide additional detail and examples regarding deviations and modifications.
  • Submit complete test reports to the manufacturer
  • Develop and submit Summary Test Reports to themanufacturers

Summary Test Reports

The appendices of the ASCA standards-specific guidances contain example Summary Test Reports which feature the information the FDA expects to review as part of the ASCA premarket device submission. If testing laboratories prefer to use their own templates, they should include all the information outlined in the example ASCA Summary Test Reports. 

Considerations for Basic Safety and Essential Performance Summary Test Reports: In addition to expectations described in the FDA’s Basic Safety and Essential Performance standards--specific guidance document, the following should be considered with respect to certain documentation in the Summary Test Reports:

  • If a testing laboratory has concerns or questions about the essential performance(s) identified by the manufacturer, the testing laboratory would ideally discuss such concerns/questions with the manufacturer when developing the test plan. If those concerns or questions remain unresolved, the testing laboratory may consider identifying such in the ASCA Summary Test Report. 
  • For clauses deemed “Not Applicable,” the testing laboratory should provide a justification with sufficient detail to explain the non-applicability of a given clause, even if that explanation is straightforward. 

Deviations and Modifications: Modifications to the methods and/or acceptance criteria included within an FDA-recognized consensus standard may be appropriate for a specific device based on its intended use. When a standard permits such modifications, those modifications do not affect compliance with the standard and a declaration of conformity may be used. However, if the standard does not permit the modifications used during testing, the modifications would be considered deviations and a declaration of conformity would not be appropriate. Therefore, since a declaration of conformity is not permitted for testing that includes deviations, such testing does not meet the criteria for inclusion in ASCA.

Note that deviations may be permitted in some circumstances within the Biocompatibility scope of the ASCA Program. Section XII.B of the ASCA Program guidance and the example Summary Test Reports in the ASCA standards-specific guidances provide additional detail and examples regarding the use of deviations and modifications.

Subcontracting: ASCA-accredited testing laboratories may subcontract testing to non-ASCA-accredited testing laboratories in the Basic Safety and Essential Performance scope only. ASCA-accredited test labs for the Biocompatibility scope may only subcontract to ASCA-accredited testing laboratories.

FDA Engagement With ASCA-Accredited Testing Laboratories

ASCA-accredited testing laboratories should be familiar with the ASCA guidance documents, which outline the FDA’s recommendations for successful participation in the program. This includes routine meetings and communication with the FDA, the provision of related documents upon request, permission to conduct audits, prompt notification to the FDA of changes that may affect the laboratory’s participation, the protection of manufacturers’ proprietary information, and acknowledgement that the FDA maintains discretion over ASCA Accreditation status.

The FDA uses a variety of mechanisms to work with ASCA-accredited testing laboratories to ensure they are adequately fulfilling program expectations. ASCA-accredited testing laboratories:

  • Should provide notification to the FDA within five calendar days via email of any changes that may impact the testing laboratory’s participation
  • Attend FDA training and regular teleconferences with the FDA
  • Submit annual reports of complaint handling that capture complaints related to the ASCA Program and the specifications defined in the ASCA guidance documents
  • Are periodically audited by the FDA

Audits: The FDA uses a tiered, risk-based approach to auditing the performance of ASCA-accredited testing laboratories.

  • For Level 1 audits, the FDA leverages the existing arrangement of assessments between accreditation bodies and testing laboratories by requesting a copy of the most recent assessment report of the testing laboratory.
  • For Level 2 audits, the FDA intends to participate as an observer during the next scheduled assessment of the testing laboratory by the accreditation body and request a copy of the report for review. 
  • For Level 3 audits, the FDA intends to initiate an on-site or remote audit of the testing laboratory.

For additional information regarding audits, please refer to the ASCA Program guidance. ASCA-accredited testing laboratories may submit a "Request for Clarification" to ASCA@fda.hhs.gov to ask questions about ASCA.

FDA does not communicate with individual testing laboratories about test reports in specific premarket submissions without consulting with the sponsor.

Maintaining ASCA Accreditation Status

Expiration: At the time ASCA Accreditation is granted to a testing laboratory, the FDA provides an expiration date for ASCA Accreditation.

Contact the FDA

After reading this page, the Accreditation Scheme for Conformity Assessment (ASCA) page, and the relevant guidances, if you have additional questions, email ASCA@fda.hhs.gov. You may also use this email address to submit documents associated with ASCA Accreditation applications and maintenance, as well as to report issues.

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