Manufacturers: How to Participate in the ASCA Pilot
The Accreditation Scheme for Conformity Assessment (ASCA) Pilot is a voluntary program through which device manufacturers may use an ASCA-accredited testing laboratory to conduct testing to be included in premarket submissions to the FDA. The ASCA Pilot is designed to significantly reduce the amount of supplemental documentation needed to support a declaration of conformity through the use of the ASCA Summary Test Reports.
On this page:
- Overview
- Eligible Devices and Submissions
- Working with an ASCA-Accredited Testing Laboratory
- Preparing and Submitting a Premarket Submission for the ASCA Pilot
- How the FDA Reviews Testing from ASCA-Accredited Testing Laboratories
- Contact the FDA
Related pages:
| Pilot Participant | Pages |
|---|---|
| Accreditation bodies |
List of ASCA-Accredited Recognized Accreditation Bodies |
| Testing laboratories |
List of ASCA-Accredited Testing Laboratories |
| All participants |
Accreditation Scheme for Conformity Assessment (ASCA) |
Overview
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.
Eligible Submissions and Devices
To be eligible for inclusion in the ASCA Pilot, a premarket submission should meet the following expectations:
- The submission is a 510(k), De Novo, Premarket Approval, or Investigational Device Exemption
- It is not submitted under the 510(k) Third Party Review Program
- Testing is performed by a testing laboratory that is ASCA-accredited at the time testing is conducted
Certain devices are excluded from eligibility in the ASCA Pilot in the biocompatibility scope. See the ASCA biocompatibility standards-specific guidance (Section II, Scope) for these exceptions.
No Requirement to Apply: There is no application process for manufacturers to participate in the ASCA Pilot. Manufacturers may follow the processes outlined below to compile device submissions containing ASCA testing. 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.
Working with an ASCA-Accredited Testing Laboratory
After identifying the ASCA Pilot standard(s) a manufacturer wishes to cite to support their device submission, they should check the Recognized Consensus Standards database for the FDA-recognized version and the extent of recognition, which can be found in each standard’s Supplementary Information Sheet (SIS). The SIS also provides information about relevant FDA guidances that should be considered when planning a device submission (with or without ASCA Pilot testing).
A manufacturer may then choose an ASCA-accredited testing laboratory based on the scope of ASCA Accreditation from the list of ASCA-accredited testing laboratories.
Though the manufacturer is responsible for the testing plan, they should work with their ASCA-accredited testing laboratory(ies) to develop and finalize the plan for their device, giving consideration to relevant FDA guidance documents (for example, Use of ISO 10993-1 Biological evaluation of medical devices, Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices) and 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 Appendices in the ASCA standards-specific guidances provide additional detail and examples regarding deviations and modifications.
For biocompatibility testing, the FDA’s Biocompatibility Assessment Resource Center offers additional information and resources for when testing needs to be conducted as well as appropriate endpoints for biological evaluation.
Under the ASCA Pilot, the testing laboratory conducts testing and submits the complete test results and Summary Test Report(s) to the manufacturer. The manufacturer includes the Summary Test Report, as received from the testing laboratory, as part of their supplemental documentation to support a declaration of conformity.
Preparing and Submitting a Premarket Submission for the ASCA Pilot
The ASCA Pilot does not alter the device manufacturer’s responsibility to address relevant information in the premarket submission. This includes the responsibility to document how testing supports premarket authorization, even when such testing is performed by an ASCA-accredited testing laboratory.
After the manufacturer receives the complete test results and Summary Test Reports from the testing laboratory, they compile the device submission. The following elements are expected in a premarket submission that is part of the ASCA Pilot:
- A submission cover letter reflecting the following:
- Clear identification of the term “ASCA”
- Name and location of the testing laboratory(ies) where testing was conducted
- ASCA-accredited Testing Laboratory Identification Number(s)
- FDA-recognized consensus standards and test methods used during testing
- A declaration of conformity for each ASCA-identified standard/test method
- Indicate whether the FDA-recognized consensus standards and test methods used were included in the testing laboratory’s scope of ASCA Accreditation at the time of testing
- Include any limitations of validity on the declaration of conformity (if applicable)
- See example declarations of conformity in the standards-specific ASCA Pilot guidance documents
- Consult the FDA guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices for additional information about declarations of conformity
- Supplemental documentation to support a declaration of conformity
- ASCA Summary Test Report(s), unaltered from what the ASCA-accredited test laboratory provided to the manufacturer
Submissions with testing conducted by ASCA-accredited testing laboratories generally do not need to include complete test reports associated with ASCA Pilot standards and test methods, unless recommended in the ASCA standards-specific guidance, or if deviations from the standard are noted (in which case complete test reports may be needed). See the ASCA standards-specific guidance documents for other recommended supplemental documentation.
Send premarket submissions that include testing from ASCA-accredited testing laboratories to the Document Control Center with a valid eCopy and a hard copy of the cover letter. For the current mailing address for CDRH's Document Control Center, see the eCopy Program for Medical Device Submissions page.
How the FDA Reviews Testing from ASCA-Accredited Testing Laboratories
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 complete declaration of conformity, which includes 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 or results within a testing laboratory's scope of ASCA Accreditation except in the circumstances outlined in the ASCA program guidance.
The voluntary ASCA Pilot does not supplant or alter existing statutory or regulatory requirements governing the decision-making process for premarket submissions.
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 [email protected].