Key Considerations for the FDA ASCA Program

The Accreditation Scheme for Conformity Assessment (ASCA) Program is a voluntary program that was launched in 2020 by the Food and Drug Administration (FDA) to improve the reliability, consistency, and regulatory confidence in medical device testing performed to FDA-recognized consensus standards. Achieving ASCA accreditation is one of the most effective ways an organization can demonstrate competency and credibility when supporting medical device submissions to the U.S. Food and Drug Administration (FDA). Becoming ASCA-accredited demonstrates an organization’s commitment to quality and technical integrity, while also providing a competitive advantage and expanding opportunities to support regulated medical device testing.

1. Understanding ASCA Accreditation

Accreditation refers to the recognition earned by an organization or, more specifically, a conformity assessment body (CAB), from an authoritative body, such as A2LA, and conveys formal demonstration of its competency to carry out specific conformity assessment tasks such as testing or inspection.

Accreditation bodies (ABs) are recognized by the U.S. Food and Drug Administration (FDA) to conduct assessments of CABs to confirm compliance with the ASCA Program requirements. To become ASCA accredited, laboratories must obtain accreditation from an FDA-recognized ASCA accreditation body. This process includes an assessment against both ISO/IEC 17025:2017 and the additional ASCA Program specifications. Laboratories may hold ISO/IEC 17025 accreditation through an accreditation body but are not considered ASCA-accredited unless the FDA has formally approved their participation in the ASCA Program. A separate application must be submitted to the FDA, and ASCA accreditation is granted only after FDA review and acceptance. It is important to note that ASCA accreditation exists only within the ASCA Program and is separate from any other accreditation an accreditation body may grant for purposes outside the ASCA Program.

NOTE: As directed by the FDA, Accreditation Bodies are not permitted to list FDA ASCA Program verbiage on the Scopes of Accreditation at this time to avoid market confusion.

2. How to Participate in ASCA

Once an organization has made the decision to become ASCA accredited, it is important to become familiar with the applicable standards and program requirements. ASCA assessments evaluate compliance with both ISO/IEC 17025 and the additional ASCA Program specifications established by the FDA.

The ISO/IEC 17025:2017 standard is made up of eight components: Scope, Normative References, Terms and Definitions, General Requirements, Structural Requirements, Resource Requirements, Process Requirements, and Management System Requirements.

The Management Systems Requirements are associated with your laboratory’s management system, whereas the Resource and Process requirements outline the elements that determine the adequacy, correctness, and reliability of the tests or calibrations your laboratory performs. A copy of the ISO/IEC 17025:2017 standard may be purchased from the International Organization for Standardization (ISO).

In addition to ISO/IEC 17025:2017 requirements, laboratories must also comply with ASCA Program specifications. The FDA has released guidance documents that outline the additional requirements laboratories must meet to participate in the ASCA Program. These include:

NOTE: For testing laboratories including biocompatibility testing methods, compliance with 21 CFR 58 Good Laboratory Practices for Nonclinical Laboratory Studies (GLP) regulations for biocompatibility testing is needed. Please obtain this certificate prior to application. An A2LA assessment that includes the GLP requirements does not equate to the FDA GLP Compliance certificate.

3. Determining Resources Needs

Providing all laboratory staff with a general ISO/IEC 17025:2017 and ASCA Program training course can assist in illustrating how every individual in the organization has a role in the accreditation process. This can be done in-house or through a public venue, and a variety of training options can be found through a simple internet search. Training can be done early in the process to help laboratory personnel gain an understanding of the standard and the overall importance of accreditation. A2LA’s preferred training vendor is A2LA WorkPlace Training.

Regarding the ASCA Program, the FDA hosted educational events and developed CDRH Learn modules, that are publicly available. The materials include the recorded presentation, printable slides, and transcript. For other resources and access to annual reports, please visit the ASCA website.

Testing laboratories interested in ASCA accreditation are encouraged to contact the FDA to discuss the application process, including the required steps and submission content. To arrange a meeting, please email ASCA@fda.hhs.gov.

NOTE: Biocompatibility laboratories may also use this email address to request a copy of the ASCA Pilot Training Companion Document for Biocompatibility Testing. This document provides additional detail on the application process for biocompatibility laboratories.

4. Perform an Internal Audit and Gap Analysis

Per section 8.8 of ISO/IEC 17025:2017, an internal audit must be conducted at planned intervals, and a record of the internal audit must be maintained. This is something that can be conducted prior to your accreditation body assessment by a qualified internal auditor whether it’s a member of the laboratory’s staff or a contracted consultant. The purpose of an internal audit is to determine if your lab is in compliance with the requirements of ISO/IEC 17025:2017, your own management system documentation and regulatory requirements (as applicable). There are no specific internal auditor training requirements specified in the ISO/IEC 17025:2017 standard and external third-party audits do not meet this requirement.

The results of the internal audit should identify any gaps or weaknesses in the laboratory’s system and determine if additional resources are needed to ensure compliance. It is essential to keep sufficient records of the internal audit results and any follow-up actions taken. The outcome of the internal audit may help determine if the laboratory is, in fact, ready for an external assessment, or if additional work is needed before applying for accreditation.

A gap analysis is a valuable tool for organizations seeking compliance with specific program requirements such as the FDA ASCA Program. By comparing current practices with program expectations, including ISO/IEC 17025:2017 compliance, documentation, and testing scope, it identifies potential nonconformances, supports corrective action planning, and improves readiness for ASCA Accreditation, reducing the risk of nonconformities during formal assessments.

5. Conduct a Management Review

Per section 8.9 of ISO/IEC 17025:2017, the lab must complete a management review at planned intervals to ensure continued suitability and identify areas for improvement. The management review is typically conducted by the testing laboratory’s top management, which has the authority and resources necessary to make changes based on the inputs (e.g. suitability of polices, corrective actions, complaints, feedback, etc.) that are identified in section 8.9.2 of the standard. The lab will determine who these individuals are, but they are typically those in leadership positions such as President, Quality Manager, Technical Manager, etc. The outputs of the management review laid out in 8.9.3, ensures that actions for improvements and need for change amongst other requirements are noted, as applicable.

Although this is not a specific requirement for the ASCA Program, it may present an opportunity to incorporate areas of ASCA related activities into the management review process to ensure the continued suitability of policies, procedures, and resources, as well as to identify areas for improvement.

6. Evaluate Accreditation Bodies

Next steps are to research, evaluate, and select an accreditation body (AB). An ASCA assessment can only be conducted through an ASCA‑recognized accreditation body. There is a current list of recognized accreditation bodies available on the FDA’s website. The list includes the accreditation bodies, along with their recognized scopes and the dates on which recognition was granted. Requirements for recognition include being a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA), as well as having the ability to assess to ISO/IEC 17025:2017 and the applicable ASCA‑specific requirements.

A2LA is among the largest accreditation bodies in the world and the only independent, 501(c)3, non-profit, internationally recognized-accreditation body in the United States. With more than 4,000 actively accredited certificates, A2LA has accredited certificates in all 50 US states and more than 50 countries.

7. Apply for accreditation

After selecting an accreditation body, it is encouraged to ask specific questions related to their accreditation process. Each accrediting body’s processes may vary, and it is important to become familiar with the organization, its staff, and any additional requirements beyond ISO/IEC 17025 and ASCA. Accreditation bodies can also provide valuable support throughout the accreditation process.

Upon receipt of the final scope and certificate of accreditation from the selected accrediting body, the testing laboratory may proceed with applying to the FDA ASCA Program. Refer to the two-step application process for additional information.

8. Maintain your ASCA Accreditation

At the time ASCA accreditation is granted, the FDA assigns an expiration date. ASCA accredited testing laboratories are responsible for ensuring their required onsite assessments are completed by the accrediting body in a timely manner. The accrediting body maintains the ISO/IEC 17025:2017 scope and certificate of accreditation.

After reading through the FDA ASCA page and relevant guides, if you have additional questions, please email ASCA@fda.hwhs.gov. This email address is also used to submit documents associated with ASCA accreditation applications and maintenance, as well as to report issues.

NOTE: The FDA does not charge a fee for testing laboratories to participate in the ASCA Program.

Ready to start earning your ISO/IEC 17025 accreditation? Contact A2LA for a free estimate request: A2LA.org/estimate-request.