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  1. Standards and Conformity Assessment Program

Accreditation Scheme for Conformity Assessment (ASCA)

ASCA Announcements

Accreditation Body Applications: The FDA intends to publish an initial list of ASCA-recognized accreditation bodies, including their scopes of ASCA Recognition, by November 25, 2020 for accreditation bodies who submitted their applications by November 4, 2020. We will update this list throughout the Pilot as additional accreditation bodies receive ASCA Recognition.

Testing Laboratory Applications: The FDA intends to publish an initial list of ASCA-accredited testing laboratories (including their scopes of ASCA Accreditation) by April 12, 2021. If testing laboratories wish to be added to this initial list, the FDA should receive their applications no later than February 9, 2021. We will update this list throughout the Pilot as additional testing laboratories receive ASCA Accreditation.

Question and Answer Sessions for Testing Laboratories: FDA invites testing laboratories who are interested in participating in the ASCA Pilot to attend Question and Answer sessions:

  • November 16, 2020, 1:30 - 3:30 pm ET: Basic Safety and Essential Performance Question and Answer session
  • November 23, 2020, 1:30 - 3:30 pm ET: Biocompatibility Question and Answer session

To receive the links to the November 16 or November 23 virtual Question and Answer sessions, or if you would like to receive notifications about the ASCA Pilot, please email ASCA@fda.hhs.gov. There is no charge to participate.

Under the ASCA Pilot, the FDA grants ASCA Recognition to qualified accreditation bodies to accredit testing laboratories to perform premarket testing for medical device companies. Relying upon international conformity assessment standards and a set of FDA-identified ASCA program specifications, the Pilot is intended to increase consistency and predictability in the FDA's approach to assessing conformance with FDA-recognized consensus standards and test methods eligible for inclusion in the ASCA Pilot in medical device premarket reviews.

The FDA is implementing the ASCA Pilot in accordance with:

  • Amendments made to Section 514(d) of the Federal Food, Drug & Cosmetic Act by the FDA Reauthorization Act of 2017 (FDARA), and
  • The Medical Device User Fee Amendments of 2017 (MDUFA IV).

On this page:


ASCA Pilot: Key Facts

Start Date: The ASCA Pilot launched on September 25, 2020.

Participants: The ASCA Pilot includes participation from accreditation bodies, testing laboratories, device manufacturers and FDA staff.

Fee for participation for accreditation bodies and testing laboratories: The FDA does not charge a fee for accreditation bodies or testing laboratories to participate in the ASCA Pilot.

Fee for participation for manufacturers: Manufacturers have funded the ASCA Pilot program through the MDUFA IV User Fee program. The FDA does not charge an additional fee for manufacturers to participate in the ASCA Pilot.

Final Guidances (September 25, 2020)

Contact: After reading this page and the guidance, if you have additional questions, email ASCA@fda.hhs.gov. You may also use this email address to submit documents and applications for the ASCA Pilot as well as to report issues.

Why the FDA Is Launching the ASCA Pilot

The ASCA Pilot supports the FDA's public health mission by providing increased confidence in testing results from ASCA-accredited testing laboratories. The ASCA Pilot:

  • Potentially decreases the burden of individual premarket submissions when manufacturers rely on testing completed by ASCA-accredited testing laboratories
  • Incorporates existing international conformity assessment standards and practices where practical
  • Was created using input from experts across the medical device manufacturing and standards conformity assessment communities

The voluntary ASCA Pilot is intended to enhance product reviewers' and device manufacturers' confidence in medical device testing, which should decrease the need for the FDA to request additional information regarding testing methodologies when a premarket submission includes declarations of conformity to an FDA-recognized consensus standard eligible for inclusion in the ASCA Pilot. Ultimately, the ASCA Pilot is intended to help the FDA ensure patients have timely and continued access to safe, effective, and high-quality medical devices.

How the ASCA Pilot Works

  1. Accreditation bodies may apply to FDA for ASCA Recognition.
  2. After review of an accreditation body's application, FDA grants ASCA Recognition to organizations who meet the ASCA Pilot qualifications specified in the ASCA Pilot program guidance. When ASCA Recognition is granted, the FDA will provide a scope of ASCA Recognition that includes the FDA-recognized consensus standards and test methods for which the accreditation body may in turn accredit testing laboratories (including both in-house and third party) under the ASCA Pilot.
  3. ASCA-recognized accreditation bodies accredit testing laboratories using ISO/IEC 17025:2017: General requirements for the competence of testing and calibration laboratories and the ASCA program specifications outlined in the standards-specific ASCA Pilot guidance documents.
  4. Testing laboratories may apply to the FDA for ASCA Accreditation.
  5. After review of a testing laboratory's application, FDA grants ASCA Accreditation to organizations who meet the ASCA Pilot qualifications specified in the ASCA Pilot program guidance. When ASCA Accreditation is granted, FDA will provide a scope of ASCA Accreditation that includes the FDA-recognized consensus standards and test methods for which the testing laboratory may conduct testing under the ASCA Pilot.
  6. A device manufacturer may choose to use an ASCA-accredited testing laboratory to conduct testing for premarket submissions to FDA. For such testing, ASCA-accredited testing laboratories provide the device manufacturer with all the information listed in the relevant ASCA program specifications. When the device manufacturer includes a declaration of conformity with the appropriate supplemental documentation (e.g., ASCA summary test report) as part of their premarket submission, FDA applies the premarket review considerations of the ASCA Pilot.
This image is a flowchart of steps one through six above.

Figure: Process flow for the ASCA Pilot

The 2018 guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices provides additional helpful information about declarations of conformity and their important role in regulatory review.

Standards Included in the ASCA Pilot

In accordance with the MDUFA IV commitment letter, the ASCA Pilot includes both cross-cutting (horizontal) and device-specific (vertical) standards, which are of public health significance and have or are able to provide the means for establishing acceptance criteria.

Based upon input from the medical device community, the FDA chose standards and tests from the biocompatibility and basic safety and essential performance series.

View ASCA Pilot Standards

Biocompatibility standards included in the ASCA Pilot:

  • ASTM F756: Standard Practice for Assessment of Hemolytic Properties of Materials
  • ASTM F720: Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
  • ISO 10993-4: Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
  • ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
  • ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
  • ISO 10993-11: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
  • USP <151>: Pyrogen Test
  • ISO 10993-12: Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

Basic safety and essential performance standards included in the ASCA pilot

Standard Standard Title
ANSI/AAMI 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (along with the FDA-recognized collateral and particular standards in the IEC/ISO 60601/80601 family)
IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements (along with the FDA-recognized particular standards in the IEC 61010 family)

Manufacturers should continue to rely on other FDA-recognized standards and provide declarations of conformity in premarket submissions (see Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices); however, other standards will not be eligible for the benefits of the ASCA Pilot.

Accreditation Body Participation

Under the ASCA Pilot, ASCA-recognized accreditation bodies accredit testing laboratories using the specifications of ISO/IEC 17025 and the ASCA program specifications associated with each eligible FDA-recognized consensus standard and test method (refer to standards-specific ASCA Pilot guidance documents for more information).

How to Apply and Qualifications: Accreditation bodies may apply to participate in the ASCA Pilot by submitting, via email to ASCA@fda.hhs.gov, documentation demonstrating that the applicant organization:

Appendix A of the ASCA Pilot program guidance offers more information on application contents for accreditation bodies. In addition, ASCA-recognized accreditation bodies may submit a "Request for Clarification" to ASCA@fda.hhs.gov to ask questions about the ASCA Pilot.

Application Review: After an initial list of ASCA-recognized accreditation bodies is published on our web page, the FDA intends to review applications for ASCA Recognition within 60 calendar days and notify the accreditation body via email of any issues that may preclude ASCA Recognition so that they may be addressed. When review is complete, the FDA will inform the accreditation body via email of the decision. If ASCA Recognition is granted, the FDA will provide a scope of ASCA Recognition and an expiration date.

List of Accreditation Bodies in the ASCA Pilot: When FDA grants ASCA Recognition to an accreditation body, it will update the ASCA-recognized Accreditation Bodies list to reflect the organization's name, its scope of ASCA Recognition and expiration date.

Number of Accreditation Bodies: There is no limit to the number of accreditation bodies who may receive ASCA Recognition.

Expiration: At the time ASCA Recognition is granted to an accreditation body, the FDA provides an expiration date for ASCA Recognition. Up to six months prior to its expiration, an accreditation body may apply to renew its ASCA Recognition following the same process outlined above.

FDA Engagement with Accreditation Bodies: The FDA uses a variety of mechanisms to work with ASCA-recognized accreditation bodies to ensure they are adequately fulfilling program expectations. ASCA-recognized accreditation bodies:

  • Attend FDA training and regular teleconferences with the FDA
  • Submit annual reports
  • Are periodically audited by the FDA

Testing Laboratory Participation

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 may work with the device manufacturer to develop a 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 Pilot 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 and Qualifications: Once testing laboratories have received accreditation from an ASCA-recognized accreditation body, they may apply to participate in the ASCA Pilot by submitting, via email to ASCA@fda.hhs.gov, documentation 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 Pilot program guidance document

Testing laboratories eligible to receive ASCA Accreditation include:

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

Appendix B of the ASCA Pilot program guidance offers more information on application contents for testing laboratories.

Good Laboratory Practices (GLP) compliance: ASCA-accredited testing laboratories are accredited for the ASCA Pilot using ISO/IEC 17025 and the ASCA program specifications. Several ASCA program specifications for biological evaluation standards and test methods address the need for GLP compliance.  

Application Review: After an initial list of ASCA-accredited testing laboratories is published on the ASCA web page, 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. If ASCA Accreditation is granted, the FDA will provide a scope of ASCA Accreditation and an expiration date.

List of Testing Laboratories in the ASCA Pilot: When FDA grants ASCA Accreditation to a testing laboratory, it will update the ASCA-accredited Testing Laboratories list to reflect the organization's name, scope of ASCA Accreditation and expiration date.

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

Expiration: At the time ASCA Accreditation is granted to a testing laboratory, the FDA provides an expiration date for ASCA Accreditation. Up to six months prior to its expiration, a testing laboratory may apply to renew its ASCA Accreditation following the same process outlined above.

FDA Engagement with Testing Laboratories: 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:

  • Attend FDA training and regular teleconferences with the FDA
  • Submit annual reports
  • Are periodically audited by the FDA

In addition, ASCA-accredited testing laboratories may submit a "Request for Clarification" to ASCA@fda.hhs.gov to ask questions about the ASCA Pilot.

Manufacturer Participation

Device manufacturers may voluntarily use an ASCA-accredited testing laboratory to conduct testing to be included in premarket submissions to the FDA. A device manufacturer using an ASCA-accredited testing laboratory to perform testing under the ASCA Pilot includes a declaration of conformity with any necessary supplemental documentation (for example, an ASCA summary test report) as part of a premarket submission.

The ASCA Pilot does not alter the device manufacturer's responsibility to address relevant information in a premarket submission. This includes documenting how testing supports marketing authorization, even when the testing is performed by an ASCA-accredited testing laboratory. For further information, refer to the ASCA Pilot program guidance which outlines the processes and policies for device manufacturers, including the selection of an ASCA-accredited testing laboratory, development of a test plan, and contents of a premarket submission.

In addition, the two standards-specific ASCA guidances offer example declarations of conformity and example ASCA summary test reports recommended for use in premarket submissions. Refer to the 2018 guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices for further recommendations on the use of standards in device submissions.

No Requirement to Apply: There is no application process for manufacturers to participate in the ASCA Pilot. However, if a manufacturer's internal or in-house testing laboratory wishes to receive ASCA Accreditation, it must follow the application procedures outlined in the ASCA program guidance.

Eligible Devices and Submissions: Testing performed by an ASCA-accredited testing laboratory can be used to support a premarket submission for any device, including device submissions for combination products.

FDA's Review of ASCA-Accredited Testing: ASCA-accredited testing laboratories agree to use methodologies consistent with the FDA-recognized consensus standards and test methods in their scope of ASCA Accreditation and the relevant ASCA program specifications. The FDA generally intends to rely on the results from ASCA-accredited testing laboratories for the purpose of premarket review without the need for additional information related to conformance with a standard when:

  • The testing is accompanied by a declaration of conformity as well as appropriate supplemental documentation (e.g., an ASCA summary test report) and
  • The standard and test methods are within the testing laboratory's scope of ASCA Accreditation at the time of testing

In addition, the FDA does not intend to question the validity of test methods within a testing laboratory's scope of ASCA Accreditation except in the circumstances outlined in the ASCA program guidance.

Manufacturer's Responsibilities for Premarket Submissions: The device manufacturer is responsible for providing all relevant information in a premarket submission. This includes documenting how testing supports marketing authorization, even when the testing is performed by an ASCA-accredited testing laboratory.

Note that the ASCA-accredited testing laboratory provides to the device manufacturer all information listed in the relevant ASCA program specifications (including the ASCA summary test report). The device manufacturer then includes the appropriate supplemental documentation (for example, the ASCA summary test report) with its own declaration of conformity in a premarket submission to the FDA.

Resources

Guidances

Webinar

The FDA hosted a webinar on the guidances on October 22, 2020. Webinar materials are available at this web page.

Annual Reports

Training Modules

The FDA has developed CDRH Learn modules on standards, each of which includes the recorded presentation, printable slides, and transcript.

To access the modules:

  • Go to CDRH Learn.
  • Click How to Study and Market Your Device.
  • Scroll down to Standards.

Other Resources

Historical information on the ASCA program is available in the FDA Archive.

Terminology

  • Standards recognition: The process whereby the FDA identifies standards to which manufacturers of medical devices may submit a declaration of conformity to demonstrate they have met relevant requirements in the FD&C Act.
  • ASCA Recognition: A status granted by the FDA to accreditation bodies that demonstrate competence in accreditation activities via the application process described in the ASCA Pilot program guidance. ASCA-recognized accreditation bodies may accredit qualified testing laboratories if the FDA-recognized consensus standards and test methods were within their scope of ASCA Recognition at the time of accreditation.
  • Accreditation: Third-party attestation in which a conformity assessment body (e.g., a testing laboratory) has formally demonstrated its competence to carry out specific conformity assessment tasks (see ISO/IEC 17000:2004 Conformity assessment - Vocabulary and general principles).
  • ASCA Accreditation: A status granted by the FDA to testing laboratories that demonstrate competence in testing via the application process described in the ASCA Pilot program guidance. One of the qualifications for ASCA Accreditation is that a testing laboratory have a scope of accreditation from an ASCA-recognized accreditation body. Note that ASCA Accreditation exists only within the ASCA Pilot and is separate from any accreditation that an accreditation body may provide to a testing laboratory for purposes other than the ASCA Pilot.
  • Suspension of ASCA Accreditation: Putting temporary constraints in place for one or more FDA-recognized consensus standards or test methods within a testing laboratory's scope of ASCA Accreditation.
  • Withdrawing ASCA Accreditation: Cancelling a testing laboratory's full scope of ASCA Accreditation; withdrawal of ASCA Accreditation removes the organization from the ASCA Pilot entirely.
  • Withdrawing ASCA Recognition: Cancelling an accreditation body's full scope of ASCA Recognition; withdrawal of ASCA Recognition removes the organization from the ASCA Pilot entirely
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