The Food and Drug Administration of the US has published the final guidance on the Pilot Accreditation Scheme for Conformity Assessment Program. The document constitutes a final version of the guidance initially issued earlier in September 2019. Due to its legal nature, the guidance does not establish any mandatory rules and requirements the industry representatives are obliged to follow–it is permitted to apply any alternative approach, providing that such an approach complies with the applicable regulations.
ASCA Pilot: Regulatory Background
According to the document, the Pilot Accreditation Scheme for Conformity Assessment Program (ASCA Pilot) is intended to accelerate international harmonization of medical device regulations since it is actually based on the international conformity assessment practices and standards. At the same time, it is also important to mention that participation in ASCA Pilot should take place on a voluntary basis – thus, the new ASCA framework does not replace or supersede any of the existing regulatory pathways to be applied in the course of filing the premarket submission. The document also contains references to voluntary consensus standards recognized by the FDA.
The ASCA Pilot has been initially introduced by the FDA Reauthorization Act 2017 (FDARA) amending section 514(d) of the Federal Food, Drug, and Cosmetic (FD&C) Act. Under the aforementioned amendment, the FDA was entitled to develop a special regulatory framework under which accreditation bodies are allowed to accredit testing laboratories to perform the conformity assessment of medical devices in the context of the voluntary consensus standards recognized by the FDA. Under such a framework the medical device manufacturers will be allowed to demonstrate conformity with the applicable voluntary consensus standards by providing the appropriate determination issued by the FDA. However, the Agency is allowed to review the determinations issued by accredited testing laboratories in the course of special reviews covering the determinations themselves or the processes and procedures established by the accredited testing laboratory. In case of significant non-compliances identified during such a review, the FDA is entitled to suspend or withdraw the accreditation.
The accreditation of testing laboratories should be performed in accordance with the ISO/IEC 17025:2017: General requirements for the competence of testing and calibration laboratories. The accreditation bodies recognized to perform accreditation under the ASCA Pilot should also apply the appropriate standards and test methods. The FDA states that the information on the particular voluntary consensus standards and test methods allowed to be used in the context of the ASCA Pilot is being published on the official website of the Program. These consensus standards and testing methods should be used by the accredited testing laboratories when conducting the conformity assessment of the medical device in questions. Upon conclusion of the assessment, the test laboratory should provide the manufacturer with the appropriate information and the ASCA summary test report based on the special template developed by the FDA.
Recognition and Accreditation Under the ASCA Pilot Program
As mentioned abve, the medical device manufacturers may apply for participation in the ASCA Pilot Program on a voluntary basis. In such a case, the manufacturer will be allowed to provide an ASCA summary test report together with the other documents included in a premarket submission as supplemental documentation to a declaration of conformity (DOC). In order for the test report to be admissible, the testing should be performed using the voluntary consensus standards recognized by the FDA, and also the methods applicable under the ASCA Pilot Program.
The determination of the accredited testing laboratory should be provided together with a declaration of conformity and an ASCA summary test report, providing that the testing itself was performed within the scope of ASCA Accreditation of the laboratory.
The FDA guidance on ASCA Pilot Program outlines two important concepts:
- ASCA Recognition – the scope of voluntary consensus standards and methods within which the particular accreditation body is entitled to accredit testing laboratories,
- ASCA Accreditation – the scope of voluntary consensus standards and methods within which the particular accredited testing laboratory is entitled to conduct conformity assessment.
In order to assist the medical device manufacturer, the Agency makes public information about:
- the ASCA-recognized accreditation bodies, the scope of ASCA Recognition of each body, and also the expiration date of an ASCA Recognition, and
- the ASCA-accredited testing laboratories and the scope of ASCA Accreditation of each laboratory, and also the expiration date of an ASCA Accreditation accordingly.
ASCA Pilot Program: Submission Process
The present FDA guidance on ASCA Pilot Program also describes the whole process associate with the alternative framework. According to the document, the ASCA Pilot project includes the following steps:
- The accreditation body applies for an ASCA Recognition,
- The FDA grants an ASCA Recognition to the qualified accreditation body,
- The accreditation body grants accreditation to the testing laboratory,
- The testing laboratory applies to the FDA for ASCA Accreditation,
- The FDA grants an ASCA Accreditation to the testing laboratory,
- Medical device manufacture selects the appropriate testing laboratory based on the scope of its accreditation,
- The ASCA testing laboratory conducts conformity assessment and provides the medical device manufacturer with the information on the device including an ASCA summary test report,
- The medical device manufacturer includes an ASCA summary test report to its premarket submission,
- The FDA reviews the submission.
It is also important to mention that the FDA intends to publish several guidance documents describing various aspects of the ASCA Pilot, while the present guidance is dedicated to the general goals of the Program and its implementation process. In particular, the voluntary consensus standards recognized by the FDA to be applied in the context of the ASCA Pilot would be described in separate «standard-specific» guidance documents. These guidance documents on applicable standards would cover the following aspects:
- The list of applicable voluntary consensus standards,
- The ASCA program specifications,
- Recommendations regarding the content of the submission,
- An example of an ASCA summary test report, and
- An example of a declaration of conformity.
Purpose and Specific Goals of the ASCA Pilot
The FDA guidance also outlines the particular purpose and goals of the ASCA Pilot Program. According to the document, the medical device manufacturers quite often refer to the applicable voluntary consensus standards to demonstrate compliance of the device in question with the applicable safety and performance requirements. In particular, the appropriate information should be indicated in the declaration of conformity to be included in the premarket submission. By providing a declaration of conformity, the medical device manufacturer actually declares compliance with the respective FDA-recognized consensus standard. In most cases, the DOC is based on the results of testing performed by the manufacturer itself. At the same time, the accuracy of testing results depends dramatically on the particular way the testing has been conducted. Thus, in certain cases, the FDA finds the information provided in a DOC as insufficient to evaluate the risks associated with the device. The engagement of an accredited testing laboratory set forth by the ASCA Pilot would allow improving the accuracy and reliability of the testing reports provided by the manufacturer in the context of premarket submission.
According to FDA guidance, the main goals of the ASCA Pilot are:
- to enhance confidence in medical device testing,
- to make the premarket review process more consistent and predictable,
- to make the use of FDA resources more effective,
- to improve the regulatory efficiency in general,
- to accelerate international harmonization.
Summarizing the information provided here above, the FDA guidance on the ASCA Pilot covers the most important aspects related to the new regulatory framework including its purposes, goals, as well as procedures associated thereto. In particular, the document outlines the roles and responsibilities of all the parties involved, applicable policies, and the way the ASCA Pilot can improve the premarket submission process in general.
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