FDA ASCA Pilot Program

1February 16, 2023

TO:IAS- TESTING LABORATORIES AND OTHER INTERESTED PARTIES.

SUBJECT: FDA ASCA Program – IAS Transition.
Dear Madam or Sir:
The U.S. Food and Drug Administration (FDA) has recognized IAS underthe Accreditation Scheme for Conformity Assessment (ASCA) program toaccredit testing laboratories that perform premarket testing for medical devicecompanies. In this program, IAS will accredit testing laboratories using the standard
ISO/IEC 17025 and the ASCA program specifications.
Relying upon international conformity assessment standards and a set of FDAidentified ASCA program specifications, the program is intended to increase
consistency and predictability in the FDA’s approach to assessing conformancewith FDA-recognized consensus standards and test methods eligible for inclusion in
the ASCA Program in medical device premarket reviews.
Ultimately, the ASCA Program is intended to help the FDA ensure patients havetimely and continued access to safe, effective, and high-quality medical devices.
In order to participate in the program, the following steps are to be taken:
1. Obtain accreditation from an ASCA-recognized accreditation body (i.e. IAS), which
includes an assessment to ISO/IEC 17025 and the ASCA program
specifications.
2. For laboratories already accredited by IAS to ISO/IEC 17025, the process involvesa scope expansion by IAS to include the ASCA program specifications.
3. The laboratory submittal of an application for ASCA Accreditation to the FDA.
This letter describes the methodology that will be used in order for IAS Accredited
Testing Laboratories, to join the ASCA Program and achieve accreditation by IAS. Thisletter is also extended for Testing Laboratories that are not currently IAS Accredited forISO/IEC 17025 but would like to become IAS Accredited for the FDA ASCA Program.

FDA ASCA Program2

In order to understand the different scenarios, there are four case studies in the Appendix.
They are as follows:
Appendix 1: A testing laboratory already accredited for ISO/IEC 17025:2017 by IAS
for the FDA-recognized consensus standards for ASCA Program (no scope expansionrequest)
Appendix 2: A testing laboratory already accredited by IAS for ISO/IEC 17025:2017
but not for the FDA-recognized consensus standards for ASCA Program
Appendix 3: A testing laboratory that is not IAS Accredited for ISO/IEC 17025:2017
but has the FDA-recognized consensus standards for ASCA Program in theiraccreditation scope (Accredited by another AB)
Appendix 4: A testing laboratory that is not currently accredited for ISO/IEC 17025:2017.
After successful completion of the accreditation process as described in the Appendix of
this document and IAS AC89, IAS will be issuing an accreditation certificate thatwill include a statement of compliance to ISO/IEC 17025:2017 and FDA ASCA Program
Specifications. The ASCA Scope will be listed separately in the same certificate inorder to be more visible to regulators and third parties.
If you have any questions, or wish to convey your laboratories’ interest in the program toIAS, please email:• Dimitrios Katsieris, IAS Manager,dimitriosk@iasonline.org• Harry Makam, IAS Accreditation Support,
hmakam@iasonline.org

Yours very truly,

Raj NathanPresident

FDA ASCA Program

3Appendix 1
A testing laboratory already accredited for ISO/IEC 17025:2017 by IAS for theFDA-recognized consensus standards for ASCA Program (no scope expansion
request)If an IAS Accredited Testing Laboratory, already has in its scope of accreditation,
FDA-recognized consensus standards for ASCA Program, IAS will be following thefollowing policy:
If the lab has requested test methods from the list of Basic Safety and Essential
Performance test methods, a representative sample will need to be witnessed /demonstrated to verify the competency of the lab. IAS will be accepting any witnesses
already performed during the last 4 years by IAS Assessors, and will not be requiring thatthese methods are witnessed again.
IAS in any case will also allocate a minimum of 1 man-day in order to verify complianceof Testing Laboratories to the additional requirements of FDA for the ISO/IEC 17025 test
methods and management system. This activity can be done remotely or onsite.

FDA ASCA Program

4Appendix 2
A testing laboratory already accredited by IAS for ISO/IEC 17025:2017 but not for
the FDA-recognized consensus standards for ASCA Program
Any test methods that are requested but are not in the current accreditation list, will beadded after a successful scope expansion assessment process.
If test methods that are requested are from Basic Safety and Essential
Performance test methods, a representative sample will need to be witnessed /demonstrated to verify the competency of the lab.
IAS in any case will also allocate a minimum of 1 man-day in order to verify complianceof Testing Laboratories to the additional requirements of FDA for the ISO/IEC 17025 test
methods and management system. This activity can be done remotely or onsite.

FDA ASCA Program

5Appendix 3
A testing laboratory that is not IAS Accredited for ISO/IEC 17025:2017 but has theFDA-recognized consensus standards for ASCA Program in their accreditation
scope (Accredited by another AB)
In this case, IAS will need to review the last 2 assessment reports from the other AB (if 2are performed), to recognize the number of test methods that will need to bedemonstrated. This number will vary upon:
The test methods already witnessed within the last 2 assessments.
The level of details of the report regarding the technical demonstrations.
If AB is signatory member of ILAC
IAS will not recognize directly any witness performed by an AB that is not FDA recognized
for the ASCA Program and will need to perform an assessment based on thefollowing requirements:
If test methods that are requested are from Basic Safety and Essential
Performance test methods, a representative sample will need to be witnessed /demonstrated to verify the competency of the lab.
IAS in any case will also allocate a minimum of 1 man-day in order to verify
compliance of Testing Laboratories to the additional requirements of FDA for the ISO/IEC
17025 test methods and management system. This activity can be done remotely oronsite. If the AB is not ILAC MLA signatory, IAS will conduct a full assessment of themanagement system.

FDA ASCA Program

6Appendix 4
A testing laboratory that is not currently accredited for ISO/IEC 17025:2017.
IAS will follow the normal procedure for accreditation of testing labs taking into
consideration the following witness requirements:a) If test methods that are requested are from Basic Safety and Essential Performance
test methods, a representative sample will need to be witnessed / demonstrated to verify
the competency of the lab.