U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Device Advice: Comprehensive Regulatory Assistance
  4. Standards and Conformity Assessment Program
  5. Accreditation Scheme for Conformity Assessment (ASCA)
  1. Standards and Conformity Assessment Program

Accreditation Scheme for Conformity Assessment (ASCA)

On September 20, 2019, the FDA issued a draft guidance entitled The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program : Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff. The comment period is open under docket FDA-2019-D-3805 for 90 days.

On October 28, 2019, the FDA hosted a webinar for manufacturers, accreditation bodies, testing labs, standards organizations and others interested in learning more about this draft guidance and the ASCA Pilot.

CDRH's Standards and Conformity Assessment Program is committed to the advancement of regulatory science in support of medical device review. An integral part of a least-burdensome approach to device review is a reliance upon international consensus standards.

In accordance with amendments made to Section 514 of the Federal Food, Drug & Cosmetic Act by the FDA Reauthorization Act of 2017, and as part of the enactment of the Medical Device User Fee Amendments of 2017, the FDA intends to implement a pilot conformity assessment initiative, entitled the Accreditation Scheme for Conformity Assessment, or ASCA. This voluntary, pilot program, is designed to increase consistency and predictability in the FDA's approach to assessing conformance with ASCA-eligible standards in medical device premarket reviews.

The ASCA Pilot is intended to reduce regulatory burden by enhancing product reviewers' confidence in medical device testing, which should decrease the need for internal FDA consultations, complete test report reviews, and additional information requests for standards which are part of the Pilot Program. Ultimately, the ASCA Pilot is intended to help the FDA ensure safe, effective, and high-quality medical devices are available to patients without avoidable delay.

On this page:


How does FDA envision the ASCA Pilot would work?

The FDA is proposing that accreditation bodies may request recognition from the FDA for their qualifications and agreements to the terms of participation in the ASCA Pilot. Once an accreditation body is recognized by the FDA to a particular scope of standards and testing, the accreditation body may in turn accredit testing laboratories (including in-house and third party) to ISO/IEC 17025 and the ASCA program specifications, which are proposed in the ASCA draft guidance.

After a testing laboratory is accredited by an accreditation body, it can apply to the FDA in a two-step process to gain ASCA accreditation. In the first step, the FDA recognizes the testing laboratory for the purposes of the ASCA Pilot, identifying the scope of ASCA-eligible standards and test methods for that laboratory. In the second step, the FDA grants it ASCA Accreditation.

Once a testing laboratory has ASCA Accreditation, it may conduct testing for manufacturers to determine conformance of a device with an ASCA-eligible standard. When a testing laboratory with ASCA Accreditation conducts testing within its recognized scope, a complete test report containing the information specified in the ASCA Pilot would be provided to the device manufacturer, who could then include a Declaration of Conformity (DOC) (along with supplemental documentation such as summary test report(s)) as part of a premarket submission to the FDA. 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.

How is the ASCA Pilot being developed?

The ASCA Pilot emerged from discussions with device manufacturers and other stakeholders prior to the negotiations for the Medical Device User Fee Amendments of 2017 (MDUFA IV), and it was further refined during the negotiations and was included in section 514(d) of the FD&C Act. The FDA established an internal team to develop the tenets of the ASCA Pilot Program. Using a least-burdensome approach, the team incorporated existing international conformity assessment standards and practices where practical.    

The ASCA team relied heavily upon input from external stakeholders as well. The first opportunity for public input was a request for comments published in the Federal Register in May of 2017. A second key element of outreach was the public workshop held May 22-23, 2018. Several hundred individuals from across the medical device manufacturing and standards conformity assessment communities participated, in person or online. This collaboration proved invaluable as the ASCA Pilot program took shape.

The Draft Guidance includes more specifics about the operational aspects of the ASCA Pilot Program and allows for another opportunity for public comments regarding the proposed ASCA Pilot. 

Who may participate in the ASCA Pilot? 

The ASCA Pilot will include participation from accreditation bodies, testing laboratories, device manufacturers, and FDA staff.  Information on how FDA proposes that accreditation bodies and testing laboratories may participate in the ASCA Pilot is discussed in the draft guidance (Section VIII.B.).

Which standards are proposed for inclusion in the ASCA Pilot?

The FDA is proposing that specific identified standards be included in the ASCA Pilot based on comments received in response to the 2017 Federal Register notice (82 FR 22548) and input from stakeholders at the 2018 ASCA public workshop. In accordance with the MDUFA IV commitment letter, the Pilot Program will include 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. The table below is a simplified version from Section VII of the draft guidance.

Table: Proposed List of Standards and Test Methods to Be Used During the ASCA Pilot

Biological evaluation of medical devices

Standard Standard Title Test method(s)
ISO 10993-4 ISO 10993-4: Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood Complement Activation
ISO 10993-4 and ASTM F756 ISO 10993-4: Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood
ASTM F756: Standard Practice for Assessment of Hemolytic Properties of Materials
Direct and Indirect Hemolysis
ISO 10993-5 ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity MEM Elution Cytotoxicity
ISO 10993-10 ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization Dermal Irritation, Intracutaneous Reactivity Irritation, Guinea Pig Maximization Sensitization, and Closed Patch Sensitization
ISO 10993-11 ISO 10993-11: Biological evaluation of medical devices – Part 11: Tests for systemic toxicity Acute Systemic Toxicity
ISO 10993-11 and USP 151 ISO 10993-11: Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
USP <151>: Pyrogen Test
Material-Mediated Pyrogenicity
ISO 10993-12 ISO 10993-12: Biological evaluation of medical devices – Part 12: Sample preparation and reference materials Sample preparation for all test types

Basic safety and essential performance

Standard Standard Title Test method(s)
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)  

When FDA finalizes the guidance, the standards included in the ASCA Pilot may be different.

Manufacturers may continue to rely on other standards and provide declarations of conformity in premarket submissions; however, other standards will not be eligible for the benefits of the ASCA Pilot.  Refer to Section VII. of the draft guidance for further information.

Will participation in the ASCA Pilot be voluntary?

Yes.

How would an accreditation body participate?

As proposed, an accreditation body or testing laboratory would apply to participate in the ASCA Pilot by submitting, via email to ASCA@fda.hhs.gov, documentation demonstrating how the applicant organization addresses the ASCA Pilot qualifications. Please refer to the draft guidance for details on what information is proposed to be included in applications (Appendix C).

The FDA is proposing to review applications from accreditation bodies and testing laboratories within 60 calendar days. After reviewing application contents, the FDA intends to notify the applicant organization via email of the issues, if any, that may preclude ASCA Pilot participation so that any issues may be addressed (if possible). When review is complete, the FDA intends to inform the applicant organization via email of our decision, including, for recognition, a scope and expiration date. Note that the scope would include only standards in the ASCA Pilot for which competence has been demonstrated. To renew a recognition, an accreditation body or testing laboratory would apply to continue ASCA Pilot participation 6 months prior to the expiration of its recognition following the same process. For further information, refer to the draft guidance (Section VIII.B.).

How would a testing laboratory participate?

The FDA is proposing that once an accreditation body is recognized by FDA to a particular scope, it may in turn accredit testing laboratories to ISO/IEC 17025 and the ASCA program specifications.

As proposed, after a testing laboratory is accredited by an accreditation body, it would apply to FDA in a two-step process to gain ASCA Accreditation. In the first step, FDA recognizes it for the purposes of the ASCA Pilot, identifying the scope of ASCA-eligible standards and test methods, and then grants ASCA Accreditation. Note that ASCA Accreditation is provided by FDA whereas an accreditation body may accredit a testing laboratory independent of participation in the ASCA Pilot. Once a testing laboratory has ASCA Accreditation, it could conduct testing for manufacturers to determine conformance of a device with a standard included in the ASCA Pilot. When a testing laboratory with ASCA Accreditation conducts such testing, a complete test report containing the information specified by the ASCA Pilot would be provided to the device manufacturer, which could then include a Declaration of Conformity (DOC) (along with supplemental documentation such as summary test reports, examples of which appear in the draft guidance), as part of a premarket submission to FDA. We encourage readers to become familiar with the 2018 guidance, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices for more information about DOCs and their important role in regulatory review.

How would a manufacturer participate in the ASCA Pilot?

The FDA is proposing that device manufacturers could voluntarily engage with testing laboratories with ASCA Accreditation to conduct testing to ASCA-eligible standards and include the results in a premarket submission. When an ASCA-accredited testing laboratory conducts such testing, a complete test report containing the information specified by the ASCA Pilot would be provided to the device manufacturer, which could then include a Declaration of Conformity (DOC) (along with supplemental documentation such as summary test report(s), examples of which appear in the draft guidance), as part of a premarket submission to FDA.

The ASCA Pilot will not alter the device manufacturer's responsibility to address relevant information in a premarket submission. This includes the responsibility to document how testing supports marketing authorization, even when such testing is performed by a testing laboratory with ASCA Accreditation. For further information, refer to the draft guidance, which proposes information on participation (Section VIII.) and example ASCA summary test reports (Appendices E and F) recommended for premarket submissions. Please see 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.

Will there be a fee for participation in the ASCA Pilot?

FDA will not charge a fee for accreditation bodies or testing laboratories to participate in the ASCA Pilot. Manufacturers have funded the program through the MDUFA IV User Fee program; however, there is no additional fee for manufacturers to participate in the ASCA Pilot. 

When does the ASCA Pilot launch?

As indicated in Section 514(d) of the FD&C Act, ASCA Pilot program initiation should occur no later than September 30, 2020.

Resources

Contact Us

If you have additional questions, you may email ASCA@fda.hhs.gov.