Effective September 19, 2023, the FDA is converting the Accreditation Scheme for Conformity 
Assessment program from a pilot to a permanent program. This transition is authorized by the 
Medical Device User Fee Amendments of 2022 (MDUFA V). This guidance was developed and 
issued prior to the enactment of MDUFA V. FDA is assessing how to revise this guidance to 
represent our current thinking on this topic, including the incorporation of best practices gained 
from the pilot phase of the Accreditation Scheme for Conformity Assessment program. For more 
information, please contact the ASCA Program at ASCA@fda.hhs.gov.   The Accreditation Scheme for 
Conformity Assessment (ASCA) 
Pilot Program
Guidance for Industry, Accreditation 
Bodies, Testing Laboratories, and 
Food and Drug Administration Staff
Document issued on September 25, 2020.
The draft of this document was issued on September 23, 2019.
For questions about this document regarding CDRH-regulated devices, contact the ASCA Pilot 
Program atASCA@fda.hhs.gov. For questions about this document regarding CBER-regulated 
devices, contact the Office of Communication, Outreach, and Development (OCOD) at 1-800- 
835-4709 or 240-402-8010, or by email at ocod@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration 
Center for Devices and Radiological Health 
Center for Biologics Evaluation and Research
OMB Control No. 0910-0889
Current expiration date available at https://www.reginfo.gov
See additional PRA statement in Section XIV of this guidance. Contains Nonbinding Recommendations 
Preface 
Public Comment 
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852.  
Identify all comments with the docket number FDA-2019-D-3805. Comments may not be acted 
upon by the Agency until the document is next revised or updated. 
Additional Copies 
CDRH 
Additional copies are available from the Internet.  You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document 
number 17037 and the complete title of the guidance in the request. 
CBER 
Additional copies are available from the Center for Biologics Evaluation and Research (CBER), 
Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., 
WO71, Room 3128, Silver Spring, MD 20993, or by calling 1-800-835-4709 or 240-402-8010, 
by email, ocod@fda.hhs.gov or from the Internet at 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-
biologics/biologics-guidances 
ii Contains Nonbinding Recommendations 
Table of Contents
 
I.  Introduction ............................................................................................................................. 1 
II.  Background ............................................................................................................................. 2 
III.  Overview ................................................................................................................................. 3 
IV.  Scope ....................................................................................................................................... 4 
V.  Terminology in the ASCA Pilot ............................................................................................. 6 
VI.  Purpose of the ASCA Pilot ..................................................................................................... 9 
VII. Specific Goals of the ASCA Pilot ......................................................................................... 10 
VIII. Development of the ASCA Pilot........................................................................................... 12 
A.  Stakeholder Input ........................................................................................................... 12 
B.  Conformity Assessment Resources ................................................................................ 12 
C.  Selection of FDA-Recognized Consensus Standards and Test Methods ....................... 14 
D.  ASCA Program Specifications Development ................................................................ 14 
IX.  Roles and Responsibilities .................................................................................................... 15 
A.  Accreditation Bodies ...................................................................................................... 15 
B.  Testing Laboratories ....................................................................................................... 15 
C.  Device Manufacturers .................................................................................................... 16 
D.  FDA Staff ....................................................................................................................... 16 
X.  Processes and Policies for Accreditation Bodies .................................................................. 17 
A.  Qualifications for ASCA Recognition ............................................................................. 17 
B.  Accreditation Body Application Process ....................................................................... 18 
C.  Extension of ASCA Recognition ..................................................................................... 18 
D.  Requests for Clarification ............................................................................................... 19 
E.  Audits of Accreditation Bodies ...................................................................................... 20 
F.  Withdrawal of ASCA Recognition .................................................................................. 21 
XI.  Processes and Policies for Testing Laboratories ................................................................... 23 
A.  Qualifications for ASCA Accreditation .......................................................................... 23 
B.  Testing Laboratory Application Process ........................................................................ 24 
C.  Extension of  ASCA Accreditation ................................................................................. 25 
D.  Requests for Clarification ............................................................................................... 25 
E.  Audits of Testing Laboratories ....................................................................................... 26 
F.  Suspension of ASCA Accreditation ................................................................................ 27 
G.  Withdrawal of ASCA Accreditation ............................................................................... 30 
XII. Processes and Policies for Device Manufacturers ................................................................ 33 
iii Contains Nonbinding Recommendations 
A.  Selection of an ASCA-accredited Testing Laboratory ................................................... 33 
B.  Development of a Test Plan ........................................................................................... 33 
C.  Contents of a Premarket Submission ............................................................................. 35 
XIII. Processes and Policies for FDA Review Staff ...................................................................... 36 
A.  General Premarket Review Policy ................................................................................. 36 
B.  Impact of Suspension of ASCA Accreditation ................................................................ 37 
C.  Impact of Withdrawal of ASCA Accreditation ............................................................... 38 
XIV.  Paperwork Reduction Act of 1995 ................................................................................. 38 
Appendix A: Application for ASCA Recognition ......................................................................... 40 
A.  Administrative Information ............................................................................................ 40 
B.  Scope of ASCA Recognition ........................................................................................... 40 
C.  Information in Support of Competence .......................................................................... 40 
D.  Signed Agreement .......................................................................................................... 41 
Appendix B: Application for ASCA Accreditation ....................................................................... 43 
A.  Administrative Information ............................................................................................ 43 
B.  Scope of ASCA Accreditation ........................................................................................ 43 
C.  Information in Support of Competence .......................................................................... 43 
D.  Signed Agreement .......................................................................................................... 43 
iv Contains Nonbinding Recommendations 
The Accreditation Scheme for 
Conformity Assessment (ASCA) 
Pilot Program
 
Guidance for Industry, Accreditation 
Bodies, Testing Laboratories, and 
Food and Drug Administration Staff 
This guidance represents the current thinking of the Food and Drug Administration (FDA 
or Agency) on this topic.  It does not establish any rights for any person and is not binding 
on FDA or the public.  You can use an alternative approach if it satisfies the requirements 
of the applicable statutes and regulations.  To discuss an alternative approach, contact the 
FDA staff or Office responsible for this guidance as listed on the title page. 
I.  Introduction 
The Pilot Accreditation Scheme for Conformity Assessment Program (hereafter referred to as the 
ASCA Pilot) is authorized under section 514(d) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act).1 In accordance with amendments made to section 514 by the FDA Reauthorization 
Act of 2017 (FDARA),2 and as part of the enactment of the Medical Device User Fee 
Amendments of 2017 (MDUFA IV),3 FDA was directed to issue a guidance regarding the goals 
and implementation of the ASCA Pilot.4 The establishment of the goals, scope, procedures, and a 
suitable framework for the voluntary ASCA Pilot supports the Agencys continued efforts to use 
its scientific resources effectively and efficiently to protect and promote public health. FDA 
believes the voluntary ASCA Pilot may further encourage international harmonization of 
medical device regulation because it incorporates elements, where appropriate, from a well-
established set of international conformity assessment practices and standards (e.g., ISO/IEC 
17000 series). The voluntary ASCA Pilot does not supplant or alter any other existing statutory 
or regulatory requirements governing the decision-making process for premarket submissions. 
                                                
1 21 U.S.C. 360d(d) 
2 See Pub. L. 115-52 
3 See also MDUFA IV Commitment Letter: https://www.fda.gov/media/100848/download 
4 See section 514(d)(3)(B) of the FD&C Act. 
1  Contains Nonbinding Recommendations 
This guidance refers to voluntary consensus standards.5 For the current edition of the FDA-
recognized consensus standard(s) referenced in this document, see the FDA Recognized 
Consensus Standards Database.6 For more information regarding use of standards in regulatory 
submissions, please refer to the FDA guidance titled Appropriate Use of Voluntary Consensus 
Standards in Premarket Submissions for Medical Devices7 and Standards Development and the 
Use of Standards in Regulatory Submissions Reviewed in CBER.8
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidance describes the Agencys current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in Agency guidance means that something is suggested or 
recommended, but not required. 
II.  Background 
FDARA amended section 514 of the FD&C Act by adding a new subsection (d) titled Pilot 
Accreditation Scheme for Conformity Assessment.9 Subsection 514(d) requires FDA to 
establish a pilot program under which testing laboratories may be accredited by accreditation 
bodies meeting criteria specified by FDA to assess the conformance of a device within certain 
FDA-recognized consensus standards. Determinations by accredited testing laboratories that a 
device conforms with an eligible standard included as part of the pilot program shall be accepted 
by FDA for the purposes of demonstrating such conformity unless FDA finds that a particular 
such determination shall not be so accepted.10
The statute provides that FDA may review determinations by accredited testing laboratories, 
including by conducting periodic audits of such determinations or processes of accreditation 
bodies or testing laboratories.11 Following such a review, or if FDA becomes aware of 
information materially bearing on safety or effectiveness of a device tested by an accredited 
testing laboratory, FDA may take additional measures as determined appropriate, including 
suspension or withdrawal of accreditation of a testing laboratory12 or a request for additional 
information regarding a specific device.13
                                                
5 For the purposes of this guidance, the term standard or standards will be used to refer to consensus standard or 
consensus standards. 
6 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 
7 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices 
8 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/standards-development-
and-use-standards-regulatory-submissions-reviewed-center-biologics-evaluation 
9 See Pub. L. 115-52, section 205 
10 See section 514(d)(1)(B) of the FD&C Act. 
11 See section 514(d)(2)(A) of the FD&C Act. 
12 Section 514(d)(2)(B) allows FDA to take additional measures such as suspension or withdrawal of accreditation 
of such testing laboratory. As used in this guidance, the term accreditation refers to the ASCA Accreditation 
granted by FDA and not the accreditation granted by an accreditation body. 
13 See section 514(d)(2)(A)-(B) of the FD&C Act. 
2 Contains Nonbinding Recommendations 
III.  Overview 
Under the ASCA Pilots conformity assessment scheme, ASCA-recognized accreditation bodies 
accredit testing laboratories using ISO/IEC 17025:2017: General requirements for the 
competence of testing and calibration laboratories and the ASCA program specifications 
associated with each FDA-recognized consensus standard and test method included in the ASCA 
Pilot. The FDA-recognized consensus standards and test methods eligible for inclusion in the 
ASCA Pilot and the ASCA program specifications are provided in the relevant standards-specific 
ASCA Pilot guidance documents which can be accessed from the ASCA website.14  
ASCA-accredited testing laboratories may conduct testing to provide data used to determine 
conformance of a device with one or more of the FDA-recognized consensus standards and test 
methods eligible for inclusion in the ASCA Pilot. 
When an ASCA-accredited testing laboratory conducts testing under the ASCA Pilot, it should 
provide to the device manufacturer all information listed in the relevant ASCA program 
specifications, including an ASCA summary test report. Example ASCA summary test reports 
for the FDA-recognized consensus standards and test methods eligible for inclusion in the ASCA 
Pilot are provided in the associated standards-specific ASCA Pilot guidance documents. 
Device manufacturers may choose to use an ASCA-accredited testing laboratory to conduct 
testing for premarket submissions to FDA. A device manufacturer that uses an ASCA-accredited 
testing laboratory to perform testing in accordance with the provisions of the ASCA Pilot can 
then include a declaration of conformity (DOC) with any necessary supplemental documentation 
(e.g., an ASCA summary test report) as part of a premarket submission to FDA. Testing 
performed by an ASCA-accredited testing laboratory can be used to support a premarket 
submission for any device if the testing was conducted using an FDA-recognized consensus 
standard and test method eligible for inclusion in the ASCA Pilot and in accordance with the 
ASCA program specifications for that standard. 
During the ASCA Pilot, FDA generally will accept determinations from ASCA-accredited 
testing laboratories (i.e., test results) when accompanied by a DOC and appropriate supplemental 
documentation (e.g., an ASCA summary test report) and when the standard and test methods are 
within the testing laboratorys scope of ASCA Accreditation at the time of testing (Refer to 
Section XIII. of this guidance).  
As part of the enactment of MDUFA IV,15 FDA committed to publish the following information 
on FDAs publicly-accessible ASCA website: 
-  A list of ASCA-recognized accreditation bodies including the FDA-recognized consensus 
standards and test methods within the scope of each accreditation bodys ASCA 
Recognition; 
                                                
14 ASCA website: https://www.fda.gov/medical-devices/standards-and-conformity-assessment-
program/accreditation-scheme-conformity-assessment-asca  
15 MDUFA IV Commitment Letter: https://www.fda.gov/media/100848/download 
3 Contains Nonbinding Recommendations 
-  A list of ASCA-accredited testing laboratories including the FDA-recognized consensus 
standards and test methods within the scope of each testing laboratorys ASCA 
Accreditation. 
To further promote transparency, FDA intends to also identify an expiration date for each 
accreditation bodys ASCA Recognition, and for each testing laboratorys ASCA Accreditation, 
on the publicly-accessible ASCA website. Figure 1 illustrates the process flow for the ASCA 
Pilot as described above and in Sections IX and X of this guidance. 
Figure 1Process flow for the ASCA Pilot. 
IV.   Scope 
Several complementary guidance documents are being used to implement the ASCA Pilot. This 
guidance describes the goals and implementation of the ASCA Pilot as required by section 
514(d)(3)(B) of the FD&C Act. Specifically: 
4 Contains Nonbinding Recommendations 
  The criteria specified by the Secretary16 used to determine whether and how an 
accreditation body or testing laboratory may participate in the ASCA Pilot. These criteria 
include: 
o  Qualifications FDA intends to consider when reviewing applications from 
accreditation bodies and testing laboratories to participate in the ASCA Pilot 
(Refer to Sections X.A. and XI.A. of this guidance); 
o  Processes FDA intends to follow, including recommended application contents, in 
granting ASCA Recognition to accreditation bodies and granting ASCA 
Accreditation to testing laboratories (Refer to Sections X.B. and XI.B. of this 
guidance); 
o  Terms of participation to which ASCA-recognized accreditation bodies and 
ASCA-accredited testing laboratories agree (Refer to Section D of Appendices A 
and B of this guidance); and 
o  ASCA program specifications associated with each eligible FDA-recognized 
consensus standard and test method developed to communicate expectations for 
how ASCA-recognized accreditation bodies accredit testing laboratories in the 
ASCA Pilot. 
  This guidance document provides a description of how the ASCA program 
specifications were developed (Refer to Section VIII.D. of this guidance). 
ASCA program specifications are located in the relevant standards-
specific ASCA Pilot guidance documents. 
  The certain standards recognized under [section 514]17 eligible for inclusion in the 
ASCA Pilot. 
o  This guidance document provides a description of how FDA-recognized 
consensus standards and test methods were selected for the ASCA Pilot, including 
considerations articulated in the MDUFA IV Commitment Letter18 (Refer to 
Section VIII.C. of this guidance). The FDA-recognized consensus standards and 
test methods eligible for inclusion in the ASCA Pilot are located in the relevant 
standards-specific ASCA Pilot guidance documents. 
  The process by which device manufacturers may incorporate testing from ASCA-
accredited testing laboratories in a submission to FDA for the purpose of demonstrating 
conformance of a device with FDA-recognized consensus standards and test methods 
eligible for inclusion in the ASCA Pilot19 (Refer to Section XII. of this guidance). 
  The policy regarding Agency review of determinations (i.e., test results) by ASCA-
accredited testing laboratories. Such determinations shall be accepted by the Secretary 
for purposes of demonstrating such conformity under this section unless the Secretary 
finds that a particular such determination shall not be so accepted20(Refer to Section 
XIII. of this guidance). 
                                                
16 See section 514(d)(1)(A) of the FD&C Act. 
17 See section 514(d)(1)(A) of the FD&C Act. 
18 See MDUFA IV Commitment Letter pg. 14: https://www.fda.gov/media/100848/download 
19 See section 514(d)(1)(B) of the FD&C Act. 
20 See section 514(d)(1)(B) of the FD&C Act. 
5 Contains Nonbinding Recommendations 
  The processes and policies FDA intends to follow when conducting periodic audits of 
such determinations or processes of accredited bodies or testing laboratories21 (Refer to 
Sections X.E. and XI.E.  of this guidance). 
  The processes and policies FDA intends to follow regarding suspension or withdrawal 
of accreditation or requesting additional information22 (Refer to Sections X.F., XI.F., 
XI.G., and XIII.B. of this guidance). 
The FDA-recognized consensus standards and test methods eligible for inclusion in the ASCA 
Pilot are identified in the relevant standards-specific ASCA Pilot guidance documents. These 
guidance(s) were developed for the purpose of being able to implement the framework described 
in this guidance and provide more detailed information for the FDA-recognized consensus 
standards and test methods eligible for inclusion in the ASCA Pilot. Each standards-specific 
ASCA Pilot guidance document includes the following information: 
  Detailed list of FDA-recognized consensus standards and test methods eligible for 
inclusion in the ASCA Pilot for assessment of the particular subject matter (e.g., 
biocompatibility testing); 
  ASCA program specifications associated with such standards and test methods; 
  Recommended premarket submission contents specific to such standards and test 
methods when testing is conducted by an ASCA-accredited testing laboratory; 
  Example ASCA summary test report(s) for such standards and test methods; and 
  Example DOC for such standards and test methods. 
The ASCA Pilot guidance documents do not address specific content for a particular premarket 
submission. For more information about the use of standards for device review, visit the 
Standards and Conformity Assessment Program website.23 See also FDAs guidance, CDRH 
Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus 
Standards for Recognition24 FDAs guidance, Appropriate Use of Voluntary Consensus 
Standards in Premarket Submissions for Medical Devices, and FDAs guidance Standards 
Development and the Use of Standards in Regulatory Submissions Reviewed in CBER. 
This guidance document is not intended to be a complete resource for understanding conformity 
assessment. Key conformity assessment resources used to develop the ASCA Pilot are described 
in Section V. of this guidance. 
V.  Terminology in the ASCA Pilot 
This section provides definitions for key terms used in the ASCA Pilot. Where possible, FDA 
has used terms already defined in the international standard ISO/IEC 17000:2004 Conformity 
assessment  Vocabulary and general principles (hereafter referred to as ISO/IEC 17000) and 
                                                
21 See section 514(d)(2)(A) of the FD&C Act. 
22 See section 514(d)(2)(A) and 514(d)(2)(B) of the FD&C Act. 
23 Available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-
and-conformity-assessment-program    
24 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cdrh-standard-
operating-procedures-identification-and-evaluation-candidate-consensus-standards-0 
6 Contains Nonbinding Recommendations 
ISO/IEC 17011 ISO/IEC 17011:2017: Conformity assessment  Requirements for accreditation 
bodies accrediting conformity assessment bodies (hereafter referred to as ISO/IEC 17011). 
Footnotes in this section indicate when a term is identical to one used in ISO/IEC 17000 or 
ISO/IEC 17011. Some definitions within ISO/IEC 17000 and ISO/IEC 17011 refer to 
requirements; FDAs references to them for the ASCA Pilot do not make them legal or 
regulatory requirements. In certain circumstances, FDA has created new terminology to describe 
specific aspects of the ASCA Pilot. 
  Accreditation: third-party attestation related to a conformity assessment body conveying 
formal demonstration of its competence to carry out specific conformity assessment 
tasks.25 An accreditation body may or may not accredit a testing laboratory independent 
of a laboratorys participation (or desire to participate) in the ASCA Pilot. 
  Accreditation body: authoritative body that performs accreditation.26
  ASCA-accredited testing laboratory: testing laboratory that has been granted ASCA 
Accreditation by FDA. ASCA-accredited testing laboratories may label their testing as 
having been conducted under the ASCA Pilot if the FDA-recognized consensus standards 
and test methods were within their scope of ASCA Accreditation at the time of testing. 
ASCA-accredited testing laboratories attend training, communicate with FDA, receive 
periodic audits, and agree to follow the other processes and policies outlined in this 
guidance (Refer to Section XI. of this guidance).  
  ASCA-recognized accreditation body: accreditation body that has been granted ASCA 
Recognition by FDA. ASCA-recognized accreditation bodies may label their 
accreditation activities as having been conducted under the ASCA Pilot if the FDA-
recognized consensus standards and test methods were within their scope of ASCA 
Recognition at the time of accreditation; ASCA-recognized accreditation bodies attend 
training, communicate with FDA, receive periodic audits, and agree to follow the other 
processes and policies outlined in this guidance (Refer to Section X. of this guidance).  
  ASCA Accreditation: status granted by FDA to testing laboratories that demonstrate 
competence in testing via the application process (Refer to Section XI.B. of this 
guidance). ASCA-accredited testing laboratories are granted a scope of ASCA 
Accreditation indicating the standards and test methods for which testing may be labeled 
as having been conducted under the ASCA Pilot. ASCA Accreditation exists only within 
the ASCA Pilot and is separate from any accreditation that an accreditation body may 
provide to a testing laboratory for purposes other than the ASCA Pilot. 
  ASCA Recognition: status granted by FDA to accreditation bodies that demonstrate 
competence in accreditation activities via the application process (Refer to Section X.B. of 
this guidance). ASCA-recognized accreditation bodies are granted a scope of ASCA 
Recognition indicating the standards and test methods for which accreditation activities 
may be labeled as having been conducted under the ASCA Pilot. 
  ASCA summary test report: documentation that summarizes the testing conducted by an 
ASCA-accredited testing laboratory within the scope of its ASCA Accreditation; an 
                                                
25 Per ISO/IEC 17000:2004 Conformity assessment  Vocabulary and general principles 
26 Ibid 
7 Contains Nonbinding Recommendations 
ASCA summary test report is specific to the ASCA Pilot and should include the 
information recommended in the standards-specific ASCA Pilot guidance documents. 
  Audit: systematic, independent, documented process for obtaining records, statements of 
fact or other relevant information and assessing them objectively to determine the extent 
to which specified requirements are fulfilled.27
o  In the ASCA Pilot, FDA uses the term audit to refer also to evaluations and 
assessments. 
  Conformity assessment: demonstration that specified requirements relating to a product, 
process, system, person, or body are fulfilled; note that the subject field of conformity 
assessment may include testing, inspection, and certification, as well as accreditation of 
conformity assessment bodies.28
  Conformity assessment body: body that performs conformity assessment services; note 
that an accreditation body is not a conformity assessment body.29
  Conformity assessment scheme: conformity assessment system related to specified 
objects of conformity assessment to which the same specified requirements, specific rules 
and procedures apply.30
  Conformity assessment system: rules, procedures, and management for carrying out 
conformity assessment.31
  Declaration of conformity (DOC): attestation made by a medical device manufacturer, in 
accordance with section 514(c)(1)(B) of the FD&C Act, regarding whether a device 
conforms with an FDA-recognized consensus standard.32
  Determinations by testing laboratories:33 test results. 
  Extending accreditation: adding conformity assessment activities to the scope of 
accreditation.34
  Extending ASCA Accreditation: adding FDA-recognized consensus standards and test 
methods to a testing laboratorys scope of ASCA Accreditation (Refer to Section XI.C. of 
this guidance). 
  Extending ASCA Recognition: adding FDA-recognized consensus standards and test 
methods to an accreditation bodys scope of ASCA Recognition (Refer to Section X.C. of 
this guidance).
 
                                                
27 Ibid 
28 Ibid 
29 Ibid 
30 Per ISO/IEC 17000, conformity assessment scheme setup varies based on the object of conformity assessment 
(e.g., medical device), the users of the scheme (e.g., regulators, medical device manufacturers), and the nature of the 
specific requirements being assessed (e.g., specific medical device standards).   
31 Per ISO/IEC 17000 
32 See FDAs guidance, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 
Devices, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices. 
33 The term determinations by testing laboratories is used in sections 514(d)(1)(b), 514(d)(2), and 514(d)(4) of the 
FD&C Act. 
34 Per ISO/IEC 17011 
8 Contains Nonbinding Recommendations 
  FDA-recognized consensus standard: standards identified by FDA (per section 514(c) of 
the FD&C Act) as appropriate for manufacturers of products to declare conformance to 
meet relevant requirements under the FD&C Act, including premarket submission 
requirements. For more information on the standards recognition process, please visit the 
Standards and Conformity Assessment Program website35 and review FDAs guidance 
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for 
Medical Devices. 
  Request for Clarification: request submitted to FDA for clarification of one or more 
specific ASCA program specifications from an ASCA-recognized accreditation body 
(Refer to Section X.D. of this guidance) or an ASCA-accredited testing laboratory (refer 
to Section XI.D. of this guidance). A Request for Clarification presents a question relative 
to implementation of ASCA program specifications. It does not include suggestions or 
requests for modifications to the ASCA Pilot or hypothetical issues. 
  Scope of accreditation: specific conformity assessment activities for which accreditation 
is sought or has been granted.36
  Scope of ASCA Accreditation: list of FDA-recognized consensus standards and test 
methods for which a testing laboratory has demonstrated competence to FDA, through 
the application process, for conducting testing for the ASCA Pilot. 
  Scope of ASCA Recognition: list of FDA-recognized consensus standards and test 
methods for which an accreditation body has demonstrated competence to FDA, through 
the application process, for accrediting testing laboratories for the ASCA Pilot. 
  Suspending ASCA Accreditation: putting temporary constraints in place for one or more 
FDA-recognized consensus standards or test methods within a testing laboratorys scope 
of ASCA Accreditation (Refer to Section XI.F. of this guidance). 
  Third-party attestation: issue of statement, based on a decision following review, that 
fulfilment of specific requirements has been demonstrated.37
  Withdrawing accreditation: cancelling accreditation for the full scope.38
  Withdrawing ASCA Accreditation: cancelling a testing laboratorys full scope of ASCA 
Accreditation; withdrawal of ASCA Accreditation removes the organization from the 
ASCA Pilot entirely (Refer to Section XI.G. of this guidance). 
  Withdrawing ASCA Recognition: cancelling an accreditation bodys full scope of ASCA 
Recognition; withdrawal of ASCA Recognition removes the organization from the ASCA 
Pilot entirely (Refer to Section X.F. of this guidance). 
VI.  Purpose of the ASCA Pilot 
Evidence of conformity to one or more FDA-recognized consensus standards is often a thorough 
and efficient way for a manufacturer to address certain questions of safety and/or effectiveness. 
                                                
35 Available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-
and-conformity-assessment-program 
36 Per ISO/IEC 17011 
37 Per ISO/IEC 17000 
38 Per ISO/IEC 17011 
9 Contains Nonbinding Recommendations 
For manufacturers and FDA to benefit from the efficiency, however, FDA must have confidence 
in the DOC.39 DOCs are discussed in section 514(c)(1)(B) of the FD&C Act and FDAs 
guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for 
Medical Devices. These resources indicate that a device manufacturer may provide a DOC to 
one or more FDA-recognized consensus standards in a premarket submission to be reviewed by 
FDA. 
A device manufacturer may declare conformity to an FDA-recognized consensus standard based 
on test results; however, there may be variability in how this testing is conducted. Given this 
variability, and because medical devices are increasingly complex and can involve high risks to 
patients, DOCs are not always sufficient to fully address FDAs questions regarding safety and 
effectiveness for premarket submissions. As a result, FDA reviewers may need to request 
additional information and review supplemental documentation as described in FDAs guidance, 
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 
Devices. In some instances, a device manufacturer may decide to repeat or revise testing based 
on FDA input. These interactions and requests for modifications in test methodology can result 
in delays and additional costs, but are needed to provide FDA with the necessary confidence in a 
DOC for its intended purpose. 
As required by FDARA40 and as part of the enactment of MDUFA IV,41 FDA committed to the 
establishment of the ASCA Pilot with stakeholder input.42 FDA held a public workshop to obtain 
input and recommendations from stakeholders regarding the goals, scope, procedures, and 
requirements for the ASCA Pilot. The feedback sought from stakeholders (Refer to Section 
VIII.A. of this guidance) was directed to the ultimate purpose of improving the efficiency of the 
premarket review process by building confidence in DOCs through the use of accredited testing 
laboratories.  
VII. Specific Goals of the ASCA Pilot 
The ASCA Pilot is intended to support FDAs public health mission by providing increased 
confidence in testing results from ASCA-accredited testing laboratories, as well as potentially 
decreasing the burden of individual premarket submissions when manufacturers rely on testing 
completed by ASCA-accredited testing laboratories.  
The overarching goals of the ASCA Pilot are intended to: 
                                                
39 See section 514(c)(1)(B) of the FD&C Act. 
40 See sections 514(d)(1) and 514(d)(3)(A) of the FD&C Act 
41 See also MDUFA IV Commitment Letter: https://www.fda.gov/media/100848/download 
42 83 FR 2165, available at https://www.federalregister.gov/documents/2018/01/16/2018-00551/accreditation-
scheme-for-conformity-assessment-of-medical-devices-to-food-and-drug 
10 Contains Nonbinding Recommendations 
  Enhance confidence in medical device testing 
The ASCA Pilot includes application processes and periodic audits of accreditation 
bodies and testing laboratories as well as the processes that will be followed for 
suspension or withdrawal. These processes and audits are intended to increase confidence 
in the testing performed by ASCA-accredited testing laboratories by ensuring that 
ASCA-recognized accreditation bodies meet the criteria specified by FDA in this 
guidance and any relevant standards-specific ASCA Pilot guidance documents 
throughout their participation in the program.43 The increased confidence in testing may 
be particularly helpful for premarket submissions that rely on DOC to FDA-recognized 
consensus standards using test results from ASCA-accredited testing laboratories. 
  Promote consistency and predictability in the premarket review process 
The ASCA Pilot does not introduce new requirements for medical device manufacturers. 
Rather, by clearly communicating expectations for how results from ASCA-accredited 
testing laboratories are included and reviewed in premarket submissions, the ASCA Pilot 
intends to promote consistency and predictability in all of FDAs premarket submission 
programs.  
  Encourage effective use of FDA resources 
The increased acceptance of DOCs under the ASCA Pilot (Refer to Section XIII. of this 
guidance) allows FDA to direct scientific and regulatory resources to other priorities. 
  Enhance regulatory efficiency 
By virtue of a testing laboratorys ASCA Accreditation, device manufacturers can be 
more confident early in the product development lifecycle that testing to the FDA-
recognized consensus standards and test methods within the laboratorys scope of ASCA 
Accreditation is likely to meet FDAs regulatory requirements. FDA expects that the 
application process, periodic audits, and clear communication among participants in the 
ASCA Pilot will decrease the need for the FDA to request additional information 
regarding testing methodologies when a premarket submission includes DOCs to a FDA-
recognized consensus standard eligible for inclusion in the ASCA Pilot. 
  Support international harmonization 
FDA used elements from international conformity assessment standards in the ISO/IEC 
17000 series to establish the ASCA Pilot. The standards within the ISO/IEC 17000 series 
are used worldwide by stakeholders including accreditation bodies, testing laboratories, 
and device manufacturers.44 In addition, most of the FDA-recognized consensus 
standards and test methods selected for the ASCA Pilot are international consensus 
                                                
43 See section 514(d)(1)(A) of the FD&C Act. 
44 See NIST SP 2000-01 ABCs of Conformity Assessment (2018) available at 
https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.2000-01.pdf 
11 Contains Nonbinding Recommendations 
standards. FDA believes the experience gained in the ASCA Pilot could broadly inform 
international harmonization efforts such as standards use across jurisdictions. 
VIII.  Development of the ASCA Pilot 
A.  Stakeholder Input 
FDA has developed the framework of the ASCA Pilot with the support and participation of 
stakeholders from industry, the conformity assessment community, and technical experts from 
the National Institute of Standards and Technology (NIST). 
In addition, FDA published a Federal Register notice45 requesting comments on a set of 
questions designed to gain insight regarding the development and overall design/approach of the 
ASCA Pilot including goals, pilot FDA-recognized consensus standards and test methods, design 
concepts, and overall program approach. Comments received in response to this notice were 
reviewed and considered in the development of this guidance. These comments were also 
informative to the public meeting required by section 514(d)(3)(A).46
As required by FDARA,47 FDA held a public workshop titled Accreditation Scheme for 
Conformity Assessment of Medical Devices to Food and Drug Administration Recognized 
Standards on May 22-23, 2018,48 to discuss and obtain input and recommendations from 
stakeholders about the ASCA Pilot, including its goals and scope as well as a suitable framework 
and procedures to facilitate implementation. The workshop is discussed on FDAs Workshop 
and Conferences website.49
Input from each of these resources has been informative in the design of the conformity 
assessment scheme and selection of the initial FDA-recognized consensus standards and test 
methods eligible for inclusion in the ASCA Pilot as discussed in this guidance as well as the 
standards-specific ASCA Pilot guidance documents. 
B.  Conformity Assessment Resources 
FDA sought to maximize the use of existing frameworks and arrangements in developing the 
ASCA conformity assessment scheme. This way, accreditation bodies and testing laboratories 
can participate in the ASCA Pilot by leveraging existing processes and knowledge, increasing 
the net benefit of participation. We also anticipate that, by using and extending existing 
                                                
45 82 FR 22548 (May 16, 2017). 
46 ASCA Public Workshop website: https://www.fda.gov/medical-devices/workshops-conferences-medical-
devices/public-workshop-accreditation-scheme-conformity-assessment-asca-medical-devices-fda-recognized 
47 See section 514(d)(3)(A) of the FD&C Act. 
48 83 FR 2165, available at https://www.federalregister.gov/documents/2018/01/16/2018-00551/accreditation-
scheme-for-conformity-assessment-of-medical-devices-to-food-and-drug 
49 Available at https://www.fda.gov/medical-devices/news-events-medical-devices/workshops-conferences-medical-
devices 
12 Contains Nonbinding Recommendations 
paradigms, the lessons learned from the ASCA Pilot will be equally applicable, and therefore 
beneficial, to other stakeholders (e.g., other regulatory authorities). 
The conformity assessment scheme used in the ASCA Pilot leverages the following well-
established set of international conformity assessment standards and arrangements that are used 
worldwide by stakeholders including accreditation bodies, testing laboratories, and device 
manufacturers: 
  International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition 
Arrangement (MRA)50
ILAC is an international organization for accreditation bodies that accredit conformity 
assessment bodies including testing laboratories. The accreditation bodies that are 
signatories to the ILAC MRA are peer evaluated in accordance with the specifications of 
ISO/IEC 17011 to demonstrate their competence.  The ILAC MRA provides an 
internationally recognized process used to accept accredited test reports. One 
qualification for ASCA Recognition is whether the accreditation body is a signatory to the 
ILAC MRA (Refer to Section X.A. of this guidance).  FDA intends to leverage ILAC 
MRA policies and procedures regarding accreditation body peer evaluations by reviewing 
peer evaluation reports and/or participating as an observer during these activities (Refer 
to Section X.E. of this guidance). 
  ISO/IEC 17011 
This international consensus standard describes the specifications for accreditation bodies 
accrediting, among others, testing laboratories. Accreditation bodies conform to ISO/IEC 
17011 in order to be a signatory to the ILAC MRA, a qualification for ASCA Recognition 
of an accreditation body (Refer to Section X.A. of this guidance). FDA intends to leverage 
the assessments conducted by accreditation bodies per ISO/IEC 17011 by reviewing 
assessment reports and/or participating as an observer during these activities (Refer to 
Section X.E. of this guidance). 
  ISO/IEC 17025:2017: General requirements for the competence of testing and 
calibration laboratories (hereafter referred to as ISO/IEC 17025) 
This international consensus standard contains specifications for laboratories to operate 
competently and generate valid results. Accreditation bodies use ISO/IEC 17025 along 
with the ASCA program specifications associated with each eligible FDA-recognized 
consensus standard or test method to accredit testing laboratories for the ASCA Pilot 
(Refer to Section IX.A. of this guidance). 
In addition to the above resources, FDA also leveraged the following NIST documents, which 
provide an overview of conformity assessment, in the design, development, and implementation 
                                                
50 For more information about ILAC, visit https://ilac.org/about-ilac/ 
13 Contains Nonbinding Recommendations 
scheme of the ASCA Pilot as outlined in this guidance document: NIST SP 2000-01 ABCs of 
Conformity Assessment (2018)51 and NIST SP 2000-02 Conformity Assessment Considerations 
for Federal Agencies (2018).52
C.  Selection of FDARecognized Consensus Standards and 
Test Methods
When deciding which FDA-recognized standards and test methods to include in the ASCA Pilot, 
FDA sought to maximize the benefit of the ASCA Pilot to the public health by selecting FDA-
recognized consensus standards and test methods that manufacturers often rely upon to address 
significant issues of safety and/or effectiveness. FDA identified FDA-recognized consensus 
standards and test methods as eligible for the ASCA Pilot based on input from stakeholders at the 
public workshop and provided in response to the Federal Register notice requesting comments. 
In accordance with the MDUFA IV commitment letter,53 these standards and test methods 
include both cross-cutting (horizontal) and device-specific (vertical) standards, are of public 
health significance, and have or are able to provide the means for establishing acceptance. 
FDA regularly considers recognition of updated editions of standards. FDA is aware that, 
depending on the nature of the changes to the new edition, revisions to the associated ASCA 
program specifications may be needed. For the edition of the FDA-recognized consensus 
standard(s) included in the ASCA Pilot, see the FDA Recognized Consensus Standards 
Database.54  
As allowed under section 514(c) of the FD&C Act and further explained in FDAs guidance 
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 
Devices, manufacturers may continue to rely on other standards and provide DOC in premarket 
submissions; however, other standards will not be eligible for the premarket review benefits of 
the ASCA Pilot (Refer to Section XIII. of this guidance). 
D.  ASCA Program Specifications Development 
ISO/IEC 17025 includes general requirements for the competence of testing and calibration 
laboratories. Sections of the standard discuss impartiality, confidentiality, organizational 
structure, resources (e.g., personnel, facilities, equipment), processes (e.g., selection and 
verification of methods, validation of methods, sampling, reporting of results), and management 
systems (e.g., corrective actions, control of records, management reviews). The ASCA program 
specifications are used in addition to ISO/IEC 17025 by ASCA-recognized accreditation bodies 
for accreditation of testing laboratories for the ASCA Pilot. In developing the ASCA program 
specifications for each set of FDA-recognized consensus standards and test methods, FDA 
                                                
51 Available at https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.2000-01.pdf 
52 Available at https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.2000-02.pdf 
53 See MDUFA IV Commitment Letter, pg. 14 at https://www.fda.gov/media/100848/download 
54 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 
14 Contains Nonbinding Recommendations 
sought to ensure that the ASCA program specifications include only those aspects of testing 
laboratory competence that are necessary above and beyond those already provided in ISO/IEC 
17025 in order to ensure confidence in device testing submitted to FDA. FDA carefully 
considered previous and current concerns with testing submitted to the FDA as well as potential 
implementation challenges for accreditation bodies and testing laboratories.  Stakeholder input 
on the ASCA program specifications was received at a public workshop55 (Refer to Section 
VIII.A. of this guidance) as well as during the guidance process.  
The ASCA program specifications are located in the standards-specific ASCA Pilot guidance 
documents. 
IX.  Roles and Responsibilities 
A.  Accreditation Bodies 
Under the ASCA Pilot, ASCA-recognized accreditation bodies accredit testing laboratories using 
the specifications of ISO/IEC 17025 and the ASCA program specifications associated with each 
eligible FDA-recognized consensus standard and test method eligible for inclusion in the ASCA 
Pilot (Refer to standards-specific ASCA Pilot guidance documents). Upon granting ASCA 
Recognition to an accreditation body, FDA intends to provide to the accreditation body a scope 
of ASCA Recognition describing the extent to which the accreditation body has demonstrated 
competence in accreditation for purposes of the ASCA Pilot. ASCA Pilot processes and policies 
for accreditation bodies are described in Section X. of this guidance. 
The responsibilities of an accreditation body (also referred to as terms of participation) are 
identified in the signed agreement section of the accreditation body application (Refer to Section 
D of Appendix A of this guidance). 
B.  Testing Laboratories 
ASCA-accredited testing laboratories perform testing in accordance with the specifications of 
ISO/IEC 17025 and ASCA program specifications associated with each eligible FDA-recognized 
consensus standard and test method included in the testing laboratorys scope of ASCA 
Accreditation. A testing laboratory may work with the device manufacturer to develop a test plan 
(Refer to Section XII.B. of this guidance).  After testing is complete, the testing laboratory 
provides the information listed in the relevant ASCA program specifications (including an 
ASCA summary test report) to the device manufacturer. A testing laboratory may label its testing 
as having been conducted under the ASCA Pilot only if the FDA-recognized consensus 
standards and test methods used were within its scope of ASCA Accreditation at the time of 
testing. 
                                                
55 Public workshop titled Accreditation Scheme for Conformity Assessment of Medical Devices to Food and Drug 
Administration-Recognized Standards on May 22-23, 2018 
15 Contains Nonbinding Recommendations 
Upon granting ASCA Accreditation, FDA intends to provide the testing laboratory with a scope 
of ASCA Accreditation describing the extent to which the testing laboratory has demonstrated 
competence in testing for purposes of the ASCA Pilot. ASCA Pilot processes and policies for 
testing laboratories are described in Section XI. of this guidance. 
The responsibilities of a testing laboratory (also referred to as terms of participation) are 
identified in the signed agreement section of the testing laboratory application (Refer to Section 
D of Appendix B of this guidance). 
C.  Device Manufacturers 
Device manufacturers may voluntarily choose to use an ASCA-accredited testing laboratory to 
conduct testing to be included in premarket submissions to FDA. The device manufacturer is 
responsible for including the appropriate information regarding device testing in its premarket 
submission (Refer to Section XII.C. of this guidance). It is the manufacturers responsibility to 
ensure FDA-recognized consensus standards and test methods are selected and used 
appropriately and that the DOC provided in a premarket submission is consistent with the 
guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for 
Medical Devices and the standards-specific ASCA Pilot guidance documents.ASCA Pilot 
 
processes and policies for device manufacturers are described in Section XII. of this guidance. 
As noted in the MDUFA IV Commitment Letter,56a device manufacturers internal testing 
laboratory is eligible for ASCA Accreditation.  In determining whether to grant ASCA 
Accreditation to a device manufacturers internal testing laboratory, FDA intends to consider the 
same factors used in determining whether to grant ASCA Accreditation to any other testing 
laboratory (Refer to Section XI.A. of this guidance). Any ASCA-accredited testing laboratory 
(including a device manufacturers internal testing laboratory) is expected to follow the 
processes and policies of this guidance and fulfill the roles and responsibilities described in 
Section XI. of this guidance. 
D.  FDA Staff 
FDA ASCA program staff manage the ASCA Pilot, including granting ASCA Recognition to 
accreditation bodies, granting ASCA Accreditation to testing laboratories, conducting audits57 of 
ASCA-recognized accreditation bodies and ASCA-accredited testing laboratories, and reviewing 
information submitted by ASCA-recognized accreditation bodies and ASCA-accredited testing 
laboratories per their terms of participation. FDA ASCA program staff are also responsible for 
the ASCA website, which provides an up-to-date listing of ASCA-recognized accreditation 
bodies (including the scopes of and expiration dates for ASCA Recognition) and ASCA-
accredited testing laboratories (including the scopes of and expiration dates for ASCA 
                                                
56 See MDUFA IV Commitment Letter pg. 14: https://www.fda.gov/media/100848/download    
57 Per NIST SP 2000-01 ABCs of Conformity Assessment (2018): Audit activities use an organized, predictable 
process for assessing records and other information to determine whether requirements have been fulfilled. FDA 
staffs audits will determine whether the processes and policies of this guidance document have been fulfilled.   
16 Contains Nonbinding Recommendations 
Accreditation). FDA ASCA program staff are responsible for ensuring consistent 
implementation of the processes and policies in this guidance document and providing any 
training to ASCA Pilot participants necessary to (a) maintain FDAs confidence in the testing 
submitted by ASCA-accredited testing laboratories and to (b) ensure that ASCA-recognized 
accreditation bodies meet the criteria specified by FDA for participation in the ASCA Pilot and 
continue to satisfy those criteria throughout their participation in the program.58 ASCA Pilot 
processes and policies for management of the ASCA Pilot are described in Sections X. and XI. 
of this guidance. 
FDA review staff conduct reviews of premarket submissions in accordance with existing 
statutes, regulations, and guidance.  When premarket submissions include testing from an 
ASCA-accredited testing laboratory, FDA review staff are responsible for applying the statute, 
section 514(d) of the FD&C Act, and the policies described in this guidance. ASCA Pilot 
processes and policies regarding review of testing from an ASCA-accredited testing laboratory 
are described in Section XIII. of this guidance. 
The FDA ASCA program staff managing the ASCA Pilot are separate and independent from the 
FDA review staff conducting premarket reviews. 
X.  Processes and Policies for Accreditation Bodies 
A.  Qualifications for ASCA Recognition 
FDA will consider the following factors in determining whether to grant ASCA Recognition to an 
accreditation body : 
1.  Does the accreditation body have a scope of signatory status of 
Testing: ISO/IEC 17025 to the International Laboratory 
Accreditation Cooperation (ILAC) Mutual Recognition 
Arrangement (MRA)? 
This factor relies on the well-established set of international standards and arrangements for 
conducting conformity assessment activities (Refer to Section VIII.B. of this guidance). 
Signatories to the ILAC MRA are peer-reviewed by other ILAC signatories for competence in 
accrediting conformity assessment bodies, which provides confidence that testing laboratories 
accredited by ILAC signatories are competent in their implementation of ISO/IEC 17025 and the 
ASCA program specifications associated with each eligible FDA-recognized consensus standard 
and test method. 
2.  Is the accreditation body based in the United States? 
Many accreditation bodies exist within and outside of the United States to support global 
conformity assessment activities. By limiting the ASCA Pilot to accreditation bodies based in the 
                                                
58 See section 514(d)(1)(A) of the FD&C Act. 
17 Contains Nonbinding Recommendations 
United States, FDA aims to effectively use limited resources to facilitate successful program 
implementation during the pilot. 
3.  Has the accreditation body agreed in writing to the terms of 
participation described in Section D of Appendix A of this guidance? 
The terms and conditions outlined in Section D of Appendix A of this guidance are designed to 
ensure transparency and accountability on the part of the accreditation body in all aspects of its 
participation in the ASCA Pilot. An accreditation body may choose not to follow the terms of 
participation at any time; however, ASCA Recognition is contingent upon following such terms. 
B.  Accreditation Body Application Process 
An accreditation body may apply for ASCA Recognition by submitting, via email to 
ASCA@fda.hhs.gov, documentation demonstrating how the applicant organization addresses the 
qualifications specified in Section X.A. of this guidance. Appendix A of this guidance provides 
more information on application contents for accreditation bodies. FDA intends to acknowledge 
receipt of the application and provide a unique ASCA Accreditation Body Identification Number 
to the accreditation body and a unique submission number used solely for tracking the 
application. 
FDA intends to review applications for ASCA Recognition within 60 calendar days. After 
reviewing application contents, FDA intends to notify the accreditation body via email of the 
issues, if any, that may preclude ASCA Recognition so that any issues may be addressed (if 
possible). When review is complete, FDA intends to inform the accreditation body via email of 
our decision. If ASCA Recognition is granted, FDA will provide a scope of and expiration date 
(e.g., two years) for ASCA Recognition. Note that the scope will include only FDA-recognized 
consensus standards and test methods in the ASCA Pilot for which competence has been 
demonstrated. When FDA grants ASCA Recognition to an accreditation body, it will update the 
ASCA website to list the organization along with its scope of and expiration date for ASCA 
Recognition.  
FDAs decision to grant ASCA Recognition to an accreditation body is discretionary. FDA may 
decide not to grant ASCA Recognition to an accreditation body, e.g., for reasons of public health 
or administrative efficiency. If FDA does not grant ASCA Recognition to an accreditation body, 
FDA intends to provide a rationale for the decision to the applicant. 
Up to six months prior to the expiration of its ASCA Recognition, an accreditation body may 
apply to renew its ASCA Recognition following the same process outlined above.  
C.  Extension of ASCA Recognition 
FDA understands that accreditation bodies may continually add capabilities to their programs 
and increase their internal expertise. FDA encourages accreditation bodies to extend their ASCA 
Recognition by adding FDA-recognized consensus standards and test methods to their scope of 
ASCA Recognition when additional competencies are attained. For example, an accreditation 
body may initially participate in the ASCA Pilot by accrediting testing laboratories for MEM 
18 Contains Nonbinding Recommendations 
Elution Cytotoxicity testing. After some time, the accreditation body may obtain additional 
resources that can also support accrediting testing laboratories for Complement Activation 
testing. The accreditation body may then apply to extend its ASCA Recognition by adding 
Complement Activation testing to its scope of ASCA Recognition. In such a situation, the FDA-
recognized consensus standards and test methods eligible for inclusion in the ASCA Pilot would 
not change, only the FDA-recognized consensus standards and test methods in the individual 
accreditation bodys scope of ASCA Recognition. 
An accreditation body may apply to extend its ASCA Recognition by following the same 
procedures used for its initial application for ASCA Recognition. That is, an accreditation body 
may submit documentation indicating how it meets the qualifications specified in Section X.A. 
of this guidance with respect to the additional FDA-recognized consensus standards or test 
methods via email to ASCA@fda.hhs.gov. Recommended application contents are described in 
Appendix A of this guidance. In addition to the contents outlined in this appendix, FDA 
recommends that the application include the following: 
  the ASCA Accreditation Body Identification Number for the accreditation body; 
  the current scope of ASCA Recognition for the accreditation body; and 
  the FDA-recognized consensus standards or test methods that the accreditation body 
requests be added to its scope of ASCA Recognition. 
FDA intends to use the same ASCA Accreditation Body Identification Number to track all 
activity for a given accreditation body, including extensions to ASCA Recognition.  
FDA intends to update the scope of ASCA Recognition of each accreditation body on the ASCA 
website as appropriate. 
D.  Requests for Clarification 
A Request for Clarification is a request submitted to FDA for clarification of one or more 
specific ASCA program specifications from an ASCA-recognized accreditation body. A Request 
for Clarification presents a question relative to implementation of ASCA program specifications. 
It does not include suggestions or requests for modifications to the ASCA Pilot or hypothetical 
issues. 
A Request for Clarification may be submitted to ASCA@fda.hhs.gov. 
19 Contains Nonbinding Recommendations 
E.  Audits of Accreditation Bodies 
FDA intends to periodically audit accreditation bodies to ensure that they are adequately 
fulfilling program expectations. 59 FDA intends to use a tiered-approach with three levels of 
audits. 
As an ILAC MRA signatory, an accreditation body must agree to maintain conformance to 
ISO/IEC 17011 and agrees to periodic monitoring that includes re-evaluations conducted every 
four years, although shorter intervals can be determined by ILAC if needed.60 For Level 1 audits 
of an accreditation body, FDA intends to leverage the existing arrangement of ILAC evaluations 
by requesting a copy of the most recent re-evaluation report. Upon review of the report, FDA 
may request clarification or additional information. FDA intends to follow the established 4-year 
schedule of the ILAC MRA. FDA may request a copy of the most recent evaluation report if the 
next peer evaluation is scheduled after the currently identified sunset of the ASCA Pilot. 61   
For Level 2 audits of the accreditation body, FDA intends to participate as an observer during the 
next scheduled ILAC peer re-evaluation and request a copy of the re-evaluation report for 
review. FDA will notify an accreditation body of the intent to participate and make the 
appropriate arrangements for an on-site visit.  FDA intends to use Level 2 audits if there is a 
reason to believe Level 1 audits would be insufficient. Reasons to conduct a Level 2 audit could 
include, but are not limited to, observing persistent issues with testing laboratories accredited by 
a particular accreditation body, observing a trend upon review of the testing laboratory and/or 
accreditation body complaint logs, or if Level 1 audits of the accreditation body do not 
adequately address issues concerning participation in the ASCA Pilot. 
For Level 3 audits, FDA intends to initiate an on-site or remote audit of an accreditation body. 
This audit will not follow the ILAC MRA peer-evaluation schedule.  FDA will work with the 
accreditation body to make the appropriate arrangements for an FDA-initiated audit. Reasons to 
conduct a Level 3 audit could include, but are not limited to if there is a public health concern 
regarding the safety of a device or when Level 1 and Level 2 audits do not adequately address 
issues concerning participation in the ASCA Pilot by the accreditation body. 
Note that FDA may request additional information from an accreditation body as a result of any 
of the audits discussed above. 
Failure to comply with the policies and processes outlined in this guidance and other related 
standards-specific ASCA Pilot guidances can lead to withdrawal of an accreditation bodys 
ASCA Recognition as described in Section X.F. of this guidance. 
                                                
59 See section 514(d)(2)(A) of the FD&C Act. 
60 See https://ilac.org/ilac-membership/membership-criteria/ for information on membership criteria for ILAC MRA 
Signatories. 
61 See section 514(d)(4) of the FD&C Act. 
20 Contains Nonbinding Recommendations 
F.  Withdrawal of ASCA Recognition 
One purpose of the ASCA Pilot is to increase FDAs confidence in testing results and DOCs 
provided in premarket submissions. In certain circumstances, and as authorized in section 
514(d)(2) of the FD&C Act, FDA may withdraw an accreditation bodys ASCA Recognition to 
maintain confidence in the results submitted under the ASCA Pilot. Withdrawal of ASCA 
Recognition cancels the accreditation bodys full scope of ASCA Recognition and removes the 
organization from the ASCA Pilot entirely. 
1.  Considerations for Withdrawal 
FDA may identify issues, using a variety of mechanisms, that raise concerns regarding an 
accreditation bodys ability to adequately fulfill its role in the ASCA Pilot. As explained in 
Section D of Appendix A of this guidance, the signed agreement included in an accreditation 
body application for ASCA Recognition contains an agreement to permit FDA to observe and 
assess ASCA-related activities. A complete accreditation body application also includes an 
agreement to provide reports and notification of any changes that may impact the organizations 
participation in the ASCA Pilot. FDA may also obtain information about the competence of an 
accreditation body and its adherence to the criteria specified by FDA for participation in the 
ASCA Pilot when it reviews and compares a testing laboratorys requested scope of ASCA 
Accreditation to the scope of accreditation provided by the accreditation body. 
Withdrawal of ASCA Recognition may be an appropriate measure when the findings from the 
periodic audits of an accreditation body suggest unreliable accreditation activities or when FDA 
becomes aware of information materially bearing on safety or effectiveness of a device for which 
the premarket submissions included testing from an ASCA-accredited testing laboratory that was 
accredited by the accreditation body (Refer to Section XIII.A. of this guidance). 
The examples below describe additional issues that might decrease FDAs confidence in an 
accreditation body and, therefore, result in withdrawal of its ASCA Recognition. This list is not 
intended to be exhaustive. 
  Violation of law or violation of policies outlined in this guidance or other standards-
specific ASCA Pilot guidances. 
FDAs confidence in the ASCA Pilot relies on the integrity of ASCA-recognized 
accreditation bodies. FDA may consider withdrawing ASCA Recognition if, based on 
credible evidence, the organization likely committed or participated in a violation of law 
or a violation of the policies outlined in this or any standards-specific ASCA Pilot 
guidance document. For example, FDA may withdraw an accreditation bodys ASCA 
Recognition if it labels accreditation activities conducted outside of its scope of ASCA 
Recognition as having been conducted under the ASCA Pilot.  
  Failure to correct nonconformity. 
If an ASCA-recognized accreditation body fails to satisfactorily correct a nonconformity 
after notification(s), FDA may withdraw the organizations ASCA Recognition depending 
21 Contains Nonbinding Recommendations 
on the nature of the nonconformity. For example, FDA may withdraw ASCA Recognition 
if, after FDA notification, the organization continually fails to address nonconformities. 
  Failure to adhere to signed agreement. 
The application for ASCA Recognition includes several items that accreditation bodies 
agree to do as part of their participation in the ASCA Pilot (Refer to Section D of 
Appendix A). For example, an accreditation body agrees to notify FDA of specific 
changes relative to the testing laboratories it has accredited for the ASCA Pilot. If an 
accreditation body repeatedly fails to provide appropriate notifications to FDA, this may 
result in withdrawal of the organizations ASCA Recognition. 
  Information materially bearing on safety or effectiveness of a device for which the 
premarket submission included testing from an ASCA-accredited testing laboratory that 
was accredited by the accreditation body.62
FDA may obtain information about safety and effectiveness of a device that reasonably 
relates to the laboratory that tested the device and, by association, the accreditation body 
that accredited the testing laboratory. For example, a device performance issue may 
reveal that an ASCA-accredited testing laboratory failed to execute the device 
manufacturers test plan correctly. A testing laboratorys repeated failure to correctly 
execute test plans could raise concerns with the competence of the accreditation body 
providing its accreditation; these concerns, especially if observed in multiple testing 
laboratories accredited by the same accreditation body, may result in withdrawal of the 
accreditation bodys ASCA Recognition.    
  Withdrawal or suspension of ASCA Accreditation for a testing laboratory that was 
accredited by the accreditation body. 
FDA relies on ASCA-recognized accreditation bodies to accredit testing laboratories for 
the ASCA Pilot. If ASCA Accreditation of a testing laboratory is suspended or 
withdrawn, FDA may consider withdrawing the ASCA Recognition of the accreditation 
body that accredited that testing laboratory for the ASCA Pilot. FDA will carefully 
consider the reasons for suspension or withdrawal of ASCA Accreditation from a testing 
laboratory when determining whether and what action (e.g., withdrawal of ASCA 
Recognition) to take with the associated accreditation body. FDA intends to notify 
accreditation bodies when ASCA Accreditation is suspended or withdrawn from testing 
laboratories they have accredited (Refer to Section XI.F.3. and XI.G.3. of this guidance). 
As with the initial decision to grant ASCA Recognition to an accreditation body, the decision to 
withdraw ASCA Recognition is discretionary. FDA may decide to withdraw ASCA Recognition 
for other reasons not listed above. 
                                                
62 See section 514(d)(2)(B) of the FD&C Act. 
22 Contains Nonbinding Recommendations 
2.  Implications for ASCA activities 
Withdrawal of an accreditation bodys ASCA Recognition removes the accreditation body from 
the ASCA Pilot. Any activities performed after withdrawal of ASCA Recognition should not be 
identified as being performed as part of the ASCA Pilot. 
Withdrawal of an accreditation bodys ASCA Recognition may affect the testing laboratories it 
accredited for the ASCA Pilot (Refer to Section XI.F.1. and XI.G.1. of this guidance).  As 
described in Section XIII.B. of this guidance, withdrawal of an accreditation bodys ASCA 
Recognition affects FDA premarket review only indirectly in that the withdrawal may result in 
suspending or withdrawing the associated testing laboratorys ASCA Accreditation. 
3.  Procedures 
When an accreditation bodys ASCA Recognition is withdrawn (and the organization is, 
therefore, removed from the ASCA Pilot), FDA intends to send a withdrawal letter via email to 
the contact on record for the accreditation body. The letter will include the reason for the 
withdrawal and, if appropriate, how the issues identified may be addressed in a future, new 
application for ASCA Recognition. 
An accreditation body may voluntarily request to withdraw its ASCA Recognition by submitting 
an email to ASCA@fda.hhs.gov. To facilitate processing, FDA recommends that an 
accreditation bodys request to withdraw its ASCA Recognition include the ASCA Accreditation 
Body Identification Number. FDA intends to confirm the withdrawal with the contact on record 
within 14 calendar days of receipt of a request for voluntary withdrawal. 
Upon withdrawal of an accreditation bodys ASCA Recognition, FDA will update the ASCA 
website as appropriate and notify all ASCA-accredited testing laboratories who received their 
accreditation from the affected accreditation body. Considerations for the ASCA-accredited 
testing laboratories are discussed in Section XI.F.1. and XI.G.1. of this guidance. 
If an accreditation body wishes to participate in the ASCA Pilot after withdrawal of its ASCA 
Recognition, the organization should submit a new application for ASCA Recognition following 
the same procedures for an initial application as outlined in this guidance. FDA recommends that 
the new application include the ASCA Accreditation Body Identification Number and indicate 
whether the withdrawal was voluntary. If withdrawal was not voluntary, FDA recommends the 
response include reference to FDAs letter and explain how all issues identified in the 
withdrawal letter were addressed. 
XI.  Processes and Policies for Testing Laboratories 
A.  Qualifications for ASCA Accreditation 
FDA intends to consider the following factors in determining whether to grant ASCA 
Accreditation to a testing laboratory: 
23 Contains Nonbinding Recommendations 
1.  Is the testing laboratorys requested scope of ASCA Accreditation 
consistent with the scope of accreditation provided by an ASCA-
recognized accreditation body? 
This factor relies on the process for granting ASCA Recognition to accreditation bodies and 
ensures that the testing laboratory is appropriately accredited. Accreditation by an ASCA-
recognized accreditation body to FDA-recognized consensus standards and test methods 
included in the ASCA Pilot provides confidence in the testing laboratory because FDA has 
determined the accreditation body is competent for the purposes of the ASCA Pilot with respect 
to the eligible FDA-recognized consensus standards and test methods.  FDAs review of the 
testing laboratorys requested scope of ASCA Accreditation and its comparison to the scope of 
accreditation provided by an ASCA-recognized accreditation body permits FDA to ensure that 
an ASCA-accredited testing laboratory has met, and continues to meet, the criteria specified by 
FDA for participation in the ASCA Pilot.63
2.  Has the testing laboratory agreed in writing to the terms of 
participation described in Section D of Appendix B of this guidance? 
The terms and conditions outlined in Section D of Appendix B of this guidance are designed to 
ensure transparency and accountability on the part of the testing laboratory in all aspects of its 
participation in the ASCA Pilot. A testing laboratory may choose not to follow the terms of 
participation at any time; however, ASCA Accreditation is contingent upon following such terms. 
B.  Testing Laboratory Application Process 
A testing laboratory may apply for ASCA Accreditation by submitting, via email to 
ASCA@fda.hhs.gov, documentation demonstrating how they address the qualifications specified 
in Section XI.A. of this guidance. Appendix B of this guidance provides more information on 
application contents for testing laboratories. FDA intends to acknowledge receipt of the 
application and provide a unique ASCA Testing Laboratory Identification Number to the testing 
laboratory and a unique submission number used solely for tracking the application. 
FDA intends to review applications for ASCA Accreditation within 60 calendar days. After 
reviewing application contents, FDA intends to notify the testing laboratory via email of the 
issues, if any, that may preclude granting ASCA Accreditation so that any issues may be 
addressed (if possible). When review is complete, FDA intends to inform the testing laboratory 
via email of our decision. If ASCA Accreditation is granted, FDA will provide a scope of and 
expiration date (e.g., two years) for ASCA Accreditation. Note that the scope will include only 
FDA-recognized consensus standards and test methods in the ASCA Pilot for which competence 
in testing has been demonstrated. When FDA grants ASCA Accreditation to a testing laboratory, 
it will update the ASCA website to list the organization along with its scope of and expiration 
date for ASCA Accreditation.  
                                                
63 See section 514(d)(1)(A) of the FD&C Act. 
24 Contains Nonbinding Recommendations 
FDAs decision to grant ASCA Accreditation to a testing laboratory is discretionary. FDA may 
decide not to grant ASCA Accreditation to a testing laboratory, e.g., for reasons of public health 
or administrative efficiency. If FDA does not grant ASCA Accreditation to a testing laboratory, 
FDA intends to provide a rationale for the decision to the applicant. 
Up to six months prior to expiration of its ASCA Accreditation, a testing laboratory may apply to 
renew its ASCA Accreditation following the same process outlined above. 
C.  Extension of  ASCA Accreditation 
FDA understands that testing laboratories may continually add capabilities to their programs and 
increase their internal expertise. FDA encourages testing laboratories to extend their ASCA 
Accreditation by adding FDA-recognized consensus standards and test methods to their scope of 
ASCA Accreditation when additional competencies are attained. For example, a testing 
laboratory may initially participate in the ASCA Pilot by conducting MEM Elution Cytotoxicity 
testing. After some time, the testing laboratory may obtain additional equipment and resources 
that can also support Complement Activation testing. The testing laboratory may then apply to 
extend its ASCA Accreditation by adding  Complement Activation testing to its scope of ASCA 
Accreditation. In such a situation, the FDA-recognized consensus standards and test methods 
eligible for inclusion in the ASCA Pilot would not change, only the FDA-recognized consensus 
standards and test methods in the individual testing laboratorys scope of ASCA Accreditation. 
A testing laboratory may apply to extend its ASCA Accreditation by following the same 
procedures used for its initial application. That is, a testing laboratory may submit documentation 
indicating how it meets the qualifications specified in Section XI.A. of this guidance with respect 
to the additional FDA-recognized consensus standards or test methods via email to 
ASCA@fda.hhs.gov. Recommended application contents are described in Appendix B of this 
guidance. In addition to the contents outlined in this appendix, FDA recommends that the 
application include the following: 
  the ASCA Testing Laboratory Identification Number of the testing laboratory; 
  the current scope of ASCA Accreditation for the testing laboratory; and 
  the FDA-recognized consensus standards or test methods that the testing laboratory 
requests be added to its scope of ASCA Accreditation. 
FDA intends to use the same ASCA Testing Laboratory Identification Number to track all 
activity for a given testing laboratory, including extensions to ASCA Accreditation. 
FDA intends to update the scope of ASCA Accreditation on the ASCA website as appropriate. 
D.  Requests for Clarification 
A Request for Clarification is a request submitted to FDA for clarification of one or more 
specific ASCA program specifications from an ASCA-accredited testing laboratory. A Request 
for Clarification presents a question relative to implementation of ASCA program specifications. 
It does not include suggestions or requests for modifications to the ASCA Pilot or hypothetical 
issues. 
25 Contains Nonbinding Recommendations 
A Request for Clarification may be submitted to ASCA@fda.hhs.gov. 
E.  Audits of Testing Laboratories 
FDA intends to periodically audit testing laboratories to ensure that they are adequately fulfilling 
program expectations.64 FDA intends to use a tiered-approach with three levels of audits. 
In order to maintain conformance with ISO/IEC 17011, an accreditation body assesses its 
accredited testing laboratories at least every 2 years. 65 For Level 1 audits of the testing 
laboratory, FDA intends to leverage the existing arrangement of assessments between 
accreditation bodies and testing laboratories by requesting a copy of the most recent assessment 
report of the testing laboratory. Upon review of the report, FDA may request clarification or 
additional information. FDA intends to follow the established schedule of accreditation body 
assessments of the testing laboratory. 
For Level 2 audits of the testing laboratories, FDA intends to participate as an observer during 
the next scheduled assessment of the testing laboratory by the accreditation body and request a 
copy of the report for review. FDA will notify the accreditation body and testing laboratory of 
the intent to participate and make the appropriate arrangements for an on-site visit. FDA intends 
to use Level 2 audits if there is a reason to believe Level 1 audits would be insufficient. Reasons 
to use a Level 2 audit could include, but are not limited to, observing persistent issues with a 
testing laboratory, observing a trend upon review of the testing laboratory complaint logs, if 
Level 1 audits of the testing laboratory do not adequately address issues concerning participation 
in the ASCA Pilot. 
For Level 3 audits, FDA intends to initiate an on-site or remote audit of the testing laboratory. 
This audit will not follow the assessment schedule established by the accreditation body. FDA 
will work directly with the testing laboratory to make the appropriate arrangements for an FDA-
initiated audit. Level 3 audits will typically be used for only issues of highest concern such as 
when Level 1 and Level 2 audits do not adequately address issues concerning participation in the 
ASCA Pilot Program. FDA will notify the appropriate accreditation body of the intent to initiate 
on-site or remote audit of the testing laboratory. 
Note that FDA may request additional information from the testing laboratory  as a result of any 
of the audits discussed above. 
Failure to comply with the policies and processes outlined in this guidance and any other related 
ASCA program guidance can lead to changes to  a testing laboratorys ASCA Accreditation as 
described in Section XI.F. and XI.G. of this guidance. 
                                                
64 See section 514(d)(2)(A) of the FD&C Act . 
65 See 7.9.3 of ISO/IEC 17011: Conformity assessment  Requirements for accreditation bodies accrediting 
conformity assessment bodies. 
26 Contains Nonbinding Recommendations 
F.  Suspension of ASCA Accreditation 
Section 514(d)(2) of the FD&C Act provides that FDA may suspend a testing laboratorys  
ASCA Accreditation. Suspension puts temporary constraints on one or more FDA-recognized 
consensus standards or test methods in a testing laboratorys scope of ASCA Accreditation while 
the issues resulting in the suspension are addressed. 
1.  Considerations for Suspension 
FDA may identify issues, using a variety of mechanisms, that raise potential concerns regarding 
a testing laboratorys ability to adequately fulfill its role in the ASCA Pilot. As explained in 
Section D of Appendix B of this guidance, the signed agreement included in a testing laboratory 
application for ASCA Accreditation contains an agreement to permit FDA to observe and assess 
ASCA-related activities. A complete testing laboratory application also includes an agreement to 
provide reports and notification of any changes that may impact the organizations participation 
in the ASCA Pilot. FDA may also obtain information about the competence of a testing 
laboratory when it reviews information from the accreditation body or testing results from the 
testing laboratory included in premarket submissions. 
Suspending ASCA Accreditation may be an appropriate measure when the findings from the 
periodic audits of the testing laboratories suggest that testing results may be unreliable or when 
FDA becomes aware of information materially bearing on safety or effectiveness of a device for 
which the premarket submissions included testing from the ASCA-accredited testing laboratory 
(Refer to Section XIII.A. of this guidance). The suspension allows FDA to maintain confidence in 
the ASCA Pilot while adapting to the needs and abilities of ASCA-accredited testing 
laboratories. 
When determining whether to suspend a testing laboratorys ASCA Accreditation, FDA considers 
whether the issues identified are of a magnitude for which a temporary constraint can adequately 
maintain confidence in the ASCA Pilot. Suspending a testing laboratorys ASCA Accreditation is 
used when confidence in the ASCA Pilot can be maintained by constraining the testing 
laboratory to label its testing as having been conducted during a period of suspension (e.g., 
temporary loss and then repair of specific test-related resources). By labeling its testing as having 
been conducted during a period of suspension, the testing laboratory clearly communicates to the 
device manufacturer, who then communicates to FDA via the premarket submission, that FDA 
may need to conduct additional review of the results (Refer to Section XIII.B. of this guidance).  
This clear communication about the status of the testing laboratory during testing maintains 
confidence in the ASCA Pilot. 
FDA will only put a temporary constraint on the FDA-recognized consensus standards and test 
methods within a testing laboratorys scope of ASCA Accreditation that are impacted by the 
issues resulting in suspension.  
FDA may consider withdrawing the testing laboratorys ASCA Accreditation if the issues 
identified are of a magnitude for which constraining the testing laboratory to label the testing as 
having been conducted during a period of suspension is inadequate to maintain confidence in the 
27 Contains Nonbinding Recommendations 
ASCA Pilot (e.g., repeated failure to correct nonconformities or follow policies and procedures 
of this guidance) (Refer to Section XI.G. of this guidance).  
The examples below describe situations in which FDA might suspend a testing laboratorys 
ASCA Accreditation. This list is not intended to be exhaustive. 
  Existence of nonconformity. 
Depending on the nature of the nonconformity identified, FDA may determine that a 
testing laboratory needs to label its testing as having been conducted during a period of 
suspension until the nonconformity is adequately addressed. The labeling constraint 
would apply only to testing conducted using the FDA-recognized consensus standards 
and test methods affected by the nonconformity. 
  Inadequate completion of training or communication with FDA. 
The application for ASCA Accreditation includes several items that testing laboratories 
agree to do as part of their participation in the ASCA Pilot (Refer to Section D of 
Appendix B). For example, a testing laboratory agrees to attend FDA training and 
communicate with FDA. If a testing laboratory fails to complete training or submit 
information to FDA, FDA may suspend its ASCA Accreditation until such training is 
completed or information is submitted. Depending on the nature of the incomplete 
training or unsubmitted information, FDA may choose to constrain labeling of testing to 
one or more of the FDA-recognized consensus standards and test methods within the 
testing laboratorys scope of ASCA Accreditation. 
  Information materially bearing on safety or effectiveness of a device for which a 
premarket submission included testing from the testing laboratory.66
FDA may become aware of information materially bearing on study conduct or quality 
for which labeling of testing results as having been conducted during a period of 
suspension is necessary to maintain confidence in the ASCA Pilot. For example, if an 
ASCA-accredited testing laboratory under the purview of 21 CFR 58 receives from the 
FDA Bioresearch Monitoring Program a warning letter including issues that impact its 
testing under the ASCA Pilot, FDA may suspend that testing laboratorys ASCA 
Accreditation until the issues are addressed. During the period of suspension (e.g., until 
the warning letter is adequately addressed), the testing laboratory would label the affected 
testing results as having been conducted during a period of suspension.      
  Withdrawal of ASCA Recognition from the accreditation body that accredited the testing 
laboratory for the ASCA Pilot. 
FDA relies on ASCA-recognized accreditation bodies to accredit testing laboratories for 
the ASCA Pilot. If the accreditation body that accredited a testing laboratory is 
                                                
66 See section 514(d)(2)(B) of the FD&C Act. 
28 Contains Nonbinding Recommendations 
withdrawn from the ASCA Pilot, FDA may suspend (or withdraw) a testing laboratorys 
ASCA Accreditation while the testing laboratory seeks accreditation from an alternative 
ASCA-recognized accreditation body. FDA will carefully consider the reasons for 
withdrawal of ASCA Recognition from the accreditation body when determining whether 
and what action (e.g., suspension or withdrawal of ASCA Accreditation) to take regarding 
the associated testing laboratories. Note that FDA intends to notify affected testing 
laboratories if their accreditation bodys ASCA Recognition is withdrawn (Refer to 
Section X.F.3. of this guidance). 
As with the initial decision to grant ASCA Accreditation to a testing laboratory, the decision to 
suspend ASCA Accreditation is discretionary. FDA may decide to suspend ASCA Accreditation 
for other reasons not listed above. 
2.  Implications for ASCA activities 
When a testing laboratorys ASCA Accreditation is suspended, temporary constraints are put on 
how it may label its testing relative to the ASCA Pilot. FDA will indicate to the testing 
laboratory the FDA-recognized consensus standards and test methods within the organizations 
scope of ASCA Accreditation for which testing (including the ASCA summary test report) should 
be labeled as having been conducted during a period of suspension.  
A device manufacturer indicates in their DOC whether the FDA-recognized consensus standards 
and test methods used by the testing laboratory were impacted by suspension of the testing 
laboratory's ASCA Accreditation (Refer to Section XIII.C.2. of this guidance). Premarket review 
considerations for testing conducted during a period of suspension are provided in Section 
XIII.B. of this guidance. 
While ASCA Accreditation is suspended, FDA expects that the testing laboratory will continue to 
adhere to the signed agreement (Refer to Section D of Appendix B of this guidance) as well as the 
policies and processes of this guidance and any other relevant standards-specific ASCA Pilot 
guidance documents. 
Suspension of a testing laboratorys ASCA Accreditation may affect the accreditation body that 
accredited it for the ASCA Pilot, depending on the reasons for suspension (Refer to Section 
X.F.1. of this guidance). At a minimum, FDA will likely discuss with the accreditation body the 
reasons for suspension as well as any plans for resolution. If FDA suspends a testing laboratorys 
ASCA Accreditation, an accreditation bodys own decision regarding that laboratory is not 
necessarily affected. An accreditation body may continue to accredit the testing laboratory; 
however, FDA would no longer recognize that accreditation for purposes of the ASCA Pilot. 
3.  Procedures 
a.  Initiating Suspension 
When FDA suspends a testing laboratorys ASCA Accreditation, we intend to send a letter via 
email to the contact on record for the testing laboratory. The letter will include the FDA-
recognized consensus standards or test methods for which testing (including ASCA summary test 
29 Contains Nonbinding Recommendations 
reports) should be labeled as having been conducted during a period of suspension and how the 
issues resulting in suspension may be addressed. 
A testing laboratory may also voluntarily request that its ASCA Accreditation be suspended. Such 
a request should be submitted to ASCA@fda.hhs.gov and include the following information. 
  the issues resulting in suspension of ASCA Accreditation; 
  the planned timeline and/or actions to address the issues resulting in ASCA Accreditation; 
  the FDA-recognized consensus standards and test methods for which the temporary 
labeling constraint applies; and 
  the testing laboratorys ASCA Testing Laboratory Identification Number. 
FDA intends to confirm requests to voluntarily suspend ASCA Accreditation with the contact on 
record within 14 calendar days of receipt of a request. 
Upon suspension of a testing laboratorys ASCA Accreditation, FDA will update the ASCA 
website to reflect the temporary constraint on the impacted FDA-recognized consensus standards 
and test methods within the testing laboratorys scope of ASCA Accreditation. FDA will also 
notify the accreditation body that accredited that testing laboratory. Considerations for the 
accreditation body are discussed in Section X.F.1. of this guidance. 
b.  Lifting Suspension 
To lift a suspension of ASCA Accreditation, a testing laboratory should send a response to 
ASCA@fda.hhs.gov documenting how all issues resulting in suspension were resolved. To 
facilitate processing, FDA recommends that the response include the ASCA Testing Laboratory 
Identification Number and indicate whether the suspension was voluntary. If suspension was not 
voluntary, FDA recommends the response include reference to FDAs suspension letter.  
Once the issues that resulted in suspension have been adequately addressed to FDAs 
satisfaction, the agency intends to send a letter via email to the contact on record indicating that 
the testing laboratorys ASCA Accreditation is no longer suspended and the temporary 
constraints have been lifted. FDA will update the ASCA website to ensure that it accurately 
reflects the scope of ASCA Accreditation. 
G.  Withdrawal of ASCA Accreditation 
Section 514(d)(2) of the FD&C Act provides that FDA may withdraw a testing laboratorys 
ASCA Accreditation. Withdrawal of ASCA Accreditation cancels the testing laboratorys full 
scope of ASCA Accreditation and removes the organization from the ASCA Pilot entirely. 
1.  Considerations for Withdrawal 
FDA may identify issues, using a variety of mechanisms, that raise concerns regarding a testing 
laboratorys ability to adequately fulfill its role in the ASCA Pilot. As explained in Section D of 
Appendix B of this guidance, the signed agreement included in a testing laboratorys application 
for ASCA Accreditation contains an agreement to permit FDA to observe and assess ASCA-
30 Contains Nonbinding Recommendations 
related activities. A complete testing laboratory application also includes an agreement to 
provide reports and notification of any changes that may impact the organizations participation 
in the ASCA Pilot. FDA may also obtain information about the competence of a testing 
laboratory when it reviews information from the accreditation body or testing results from the 
testing laboratory included in premarket submissions. 
Withdrawal of a testing laboratorys ASCA Accreditation may be an appropriate measure 
depending on the findings from periodic audits of testing laboratories or when FDA becomes 
aware of information materially bearing on safety or effectiveness of a device for which a 
premarket submission included testing from an ASCA-accredited testing laboratory (Refer to 
Section XIII.A. of this guidance). 
When determining whether to withdraw a testing laboratorys ASCA Accreditation, FDA intends 
to consider whether the issues identified are of a magnitude for which a temporary constraint 
cannot adequately maintain confidence in the ASCA Pilot. Withdrawal of a testing laboratorys 
ASCA Accreditation is used when confidence in the ASCA Pilot cannot be maintained by 
constraining the testing laboratory to label its testing as having been conducted during a period 
of suspension (e.g., repeated failure to correct nonconformities or follow policies and procedures 
of this guidance).  
The examples below describe situations in which FDA may consider withdrawing a testing 
laboratorys ASCA Accreditation. This list is not intended to be exhaustive. 
  Violation of law or violation of policies outlined in this guidance and other standards-
specific ASCA Pilot guidances. 
FDAs confidence in the ASCA Pilot relies on the integrity of ASCA-accredited testing 
laboratories. FDA may consider withdrawing  a testing laboratorys ASCA Accreditation 
if, based on credible evidence, the organization likely committed or participated in a 
violation of law or a violation of the policies outlined in this or any standards-specific 
ASCA Pilot guidance document. For example, FDA may withdraw a testing laboratorys 
ASCA Accreditation, thereby removing it from the ASCA Pilot, if it labels testing results 
conducted outside of its scope as having been conducted under the ASCA Pilot. 
  Failure to correct nonconformity. 
If an ASCA-accredited testing laboratory fails to satisfactorily correct a nonconformity 
after notification(s) by either their accreditation body or FDA, FDA may consider 
withdrawing its ASCA Accreditation depending on the nature of the nonconformity. 
  Failure to adhere to signed agreement. 
The application for ASCA Accreditation includes several items that testing laboratories 
agree to do as part of their participation in the ASCA Pilot (Refer to Section D of 
Appendix B). For example, a testing laboratory agrees to notify FDA of changes that may 
affect its participation in the ASCA Pilot. If a testing laboratory repeatedly fails to 
31 Contains Nonbinding Recommendations 
provides appropriate notifications to FDA, this may result in withdrawal of the 
organizations ASCA Accreditation. 
  Information materially bearing on safety or effectiveness of a device for which a 
premarket submission included testing from the testing laboratory.67
FDA may become aware of information materially bearing on study conduct or quality. 
For example, if an ASCA-accredited testing laboratory under the purview of 21 CFR 58 
receives from the FDA Bioresearch Monitoring Program a warning letter including issues 
that impact its testing under the ASCA Pilot and fails to correct such issues, FDA may 
withdraw that testing laboratorys ASCA Accreditation.  
  Withdrawal of ASCA Recognition from the accreditation body that accredited the testing 
laboratory for the ASCA Pilot. 
FDA relies on ASCA-recognized accreditation bodies to accredit testing laboratories for 
the ASCA Pilot. If the accreditation body that accredited a testing laboratory is 
withdrawn from the ASCA Pilot,  FDA may withdraw (or suspend) a testing laboratorys  
ASCA Accreditation while the testing laboratory seeks accreditation from an alternative 
ASCA-recognized accreditation body. FDA will carefully consider the reasons for 
withdrawal of ASCA Recognition from the accreditation body when determining whether 
and what action (e.g., withdrawal of suspension of ASCA Accreditation) to take regarding 
the associated testing laboratories.  Note that FDA intends to notify affected testing 
laboratories if their accreditation bodys ASCA Recognition is withdrawn (Refer to 
Section X.F.3. of this guidance). 
As with the initial decision to grant ASCA Accreditation to a testing laboratory, the decision to 
withdraw ASCA Accreditation is discretionary. FDA may decide to withdraw ASCA 
Accreditation for other reasons not listed above. 
2.  Implications for ASCA activities 
Withdrawal of a testing laboratorys ASCA Accreditation removes the testing laboratory from  
the ASCA Pilot. Any activities performed after withdrawal of ASCA Accreditation should not be 
identified as being performed as part of the ASCA Pilot. 
Withdrawal of a testing laboratorys ASCA Accreditation may affect the accreditation body that 
accredited it for the ASCA Pilot, depending on the reasons for withdrawal (Refer to Section 
X.F.1. of this guidance).  Premarket review considerations for testing conducted after withdrawal 
of a testing laboratorys ASCA Accreditation are provided in Section XIII.B. of this guidance. 
If FDA withdraws a testing laboratorys ASCA Accreditation, an accreditation bodys own 
decision regarding that laboratory is not necessarily affected. An accreditation body may 
                                                
67 See section 514(d)(2)(B) of the FD&C Act. 
32 Contains Nonbinding Recommendations 
continue to accredit the testing laboratory; however, FDA would no longer recognize that 
accreditation for purposes of the ASCA Pilot. 
3.  Procedures 
When a testing laboratorys ASCA Accreditation is withdrawn (and the organization is, therefore, 
removed from the ASCA Pilot), FDA intends to send a withdrawal letter via email to the contact 
on record for the testing laboratory. The letter will include the reason for the withdrawal and, if 
appropriate, how the issues identified may be addressed in a future, new application for ASCA 
Accreditation. A testing laboratory may voluntarily request withdrawal of its ASCA 
Accreditation by submitting an email to ASCA@fda.hhs.gov. To facilitate processing, FDA 
recommends that a testing laboratorys request to withdraw from the ASCA Pilot include the 
ASCA Testing Laboratory Identification Number. FDA intends to confirm the withdrawal with 
the contact on record within 14 calendar days of receipt of a request for voluntary withdrawal. 
Upon withdrawal of a testing laboratorys ASCA Accreditation, FDA will update the ASCA 
website as appropriate and notify the accreditation body that accredited that testing laboratory for 
the ASCA Pilot. Considerations for the accreditation body are discussed in Section X.F.1. of this 
guidance. 
If a testing laboratory wishes to participate in the ASCA Pilot after withdrawal of its ASCA 
Accreditation, the organization should submit a new application for ASCA Accreditation 
following the same procedures for an initial application as outlined in this guidance. FDA 
recommends that the new application for ASCA Accreditation include the ASCA Testing 
Laboratory Identification Number and indicate whether the withdrawal was voluntary. If 
withdrawal was not voluntary, FDA recommends the application include reference to FDAs 
letter and explain how all issues identified in the withdrawal letter were addressed. 
XII. Processes and Policies for Device Manufacturers 
A.  Selection of an ASCAaccredited Testing Laboratory
Device manufacturers may voluntarily choose to use an ASCA-accredited testing laboratory to 
conduct testing included in a premarket submission. The ASCA website provides an up-to-date 
listing of ASCA-accredited testing laboratories (including their scopes of and expiration dates for 
ASCA Accreditation).  In selecting an ASCA-accredited testing laboratory, FDA recommends 
that a device manufacturer consider the FDA-recognized consensus standards and test methods 
within a testing laboratorys scope of ASCA Accreditation in comparison to the testing the device 
manufacturer plans. A device manufacturer may wish to stipulate in their contract with an 
ASCA-accredited testing laboratory that the testing laboratory notify the device manufacturer if 
the testing laboratorys ASCA Accreditation is suspended or withdrawn. 
B.  Development of a Test Plan 
The ASCA Pilot does not alter the device manufacturers responsibility to ensure FDA-
recognized consensus standards and test methods are selected and used appropriately as 
33 Contains Nonbinding Recommendations 
described in FDAs guidance Appropriate Use of Voluntary Consensus Standards in Premarket 
Submissions for Medical Devices. Given an ASCA-accredited testing laboratorys expertise, a 
manufacturer may choose to work with them in developing a test plan for their device. FDA 
recommends that development of a test plan for conduct by an ASCA-accredited testing 
laboratory consider the following: 
  Other FDA guidance and FDA-recognized consensus standards. 
FDA recommends that a test plan consider all relevant FDA guidance (e.g., device 
type guidance, scientific area guidance, submission type guidance) and FDA-
recognized consensus standards. For example, FDA recommends that a test plan for 
basic safety and essential performance consider the collateral and particular standards 
to determine the most efficient and appropriate test plan. As another example, FDAs 
guidance Bone Anchors- Premarket Notification (510(k)) Submissions68 provides 
specific recommendations for a bone anchor 510(k) submission, including 
performance test recommendations such as biocompatibility testing. 
  Impact of deviations from FDA-recognized consensus standards. 
Modifications to the methods and/or acceptance criteria included within an FDA-
recognized consensus standard may be appropriate for a specific device based on its 
intended use. When a standard permits such modifications, the modifications do not 
affect compliance with the standard and, therefore, a DOC is appropriate.  However, 
if the standard does not permit the modifications used during testing, the 
modifications would be considered deviations and the testing would not be 
considered to have been conducted in compliance with the standard. A DOC would 
not be appropriate for testing that includes deviations. Testing that includes deviations 
(and for which a DOC would not be appropriate)69 does not meet the criteria for 
inclusion in the ASCA Pilot and the premarket review considerations described in 
Section XIII. of this guidance do not apply. This is because, under the ASCA Pilot, 
device manufacturers may include in their premarket submissions DOCs based on 
testing from ASCA-accredited testing laboratories.70 Deviations (i.e., modifications 
not specifically allowed by the FDA-recognized consensus standard) necessarily 
indicate that a device does not conform to the standard; therefore, a DOC would not 
be appropriate. Note that the testing may still be appropriate for general use of 
consensus standards as described in FDAs guidance, Appropriate Use of Voluntary 
Consensus Standards in Premarket Submissions for Medical Devices.   
  Testing outside of a testing laboratorys scope of ASCA Accreditation. 
                                                
68 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bone-anchors-
premarket-notification-510k-submissions 
69 See section IV.B. of FDAs guidance Appropriate Use of Voluntary Consensus Standards in Premarket 
Submissions for Medical Devices 
70 See section 514(d)(1)(B) of the FD&C Act. 
34 Contains Nonbinding Recommendations 
A test plan may include some methods that are and some methods that are not 
included in a testing laboratorys scope of ASCA Accreditation. The processes and 
policies within this guidance and other relevant standards-specific ASCA Pilot 
guidances, including the ASCA program specifications applicable to the specific 
FDA-recognized consensus standards and test methods, apply to all testing conducted 
within a testing laboratorys scope of ASCA Accreditation. The premarket review 
considerations discussed in Section XIII. of this guidance apply only to testing 
conducted by an ASCA-accredited testing laboratory within their scope of ASCA 
Accreditation. Section XII.C. of this guidance describes how to clarify in a premarket 
submission which testing was conducted within the ASCA Pilot and which was not. 
For testing not within a testing laboratorys scope of ASCA Accreditation, please see 
FDAs guidance, Appropriate Use of Voluntary Consensus Standards in Premarket 
Submissions for Medical Devices. 
Q-Submission.
   
A device manufacturer may follow the policies and procedures in FDAs guidance 
Requests for Feedback and Meetings for Medical Device Submissions: The Q-
Submission Program71 to receive feedback from FDA regarding a proposed test plan.
 
C.  Contents of a Premarket Submission 
Testing performed by an ASCA-accredited testing laboratory can be used to support a premarket 
submission for any device if the testing was conducted using an FDA-recognized consensus 
standard and test method eligible for inclusion in the ASCA Pilot and in accordance with the 
ASCA program specifications for that standard and test method.  The ASCA Pilot does not alter 
the device manufacturers 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. 
As mentioned in Section IV. of this guidance, this guidance document does not address specific 
content for a particular premarket submission. Rather this guidance document describes how a 
device manufacturer may incorporate testing results from an ASCA-accredited testing laboratory 
into its premarket submissions. Device manufacturers should also review FDAs guidance 
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 
Devices, which further describes recommended premarket submission content when an FDA-
recognized consensus standard is used. 
1.  Cover Letter 
FDA recommends that manufacturers include the following information in the cover letter for a 
premarket submission containing testing results from an ASCA-accredited testing laboratory. 
                                                
71 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-
meetings-medical-device-submissions-q-submission-program 
35 Contains Nonbinding Recommendations 
  Clear identification of the term ASCA 
  Name(s) and location(s) of the testing laboratory(ies) where testing was conducted 
  ASCA Testing Laboratory Identification Number(s) 
  FDA-recognized consensus standard(s) (and specific test methods) used during testing. 
Note: The premarket review considerations in Section XIII. of this guidance apply only to 
FDA-recognized consensus standards (and specific test methods) within the laboratorys 
scope of ASCA Accreditation at the time of testing. 
2.  Declaration of Conformity (DOC) 
Section IV.A. of FDAs guidance, Appropriate Use of Voluntary Consensus Standards in 
Premarket Submissions for Medical Devices recommends contents for a DOC to an FDA-
recognized consensus standard.  For testing from an ASCA-accredited testing laboratory, 
additional items are recommended for inclusion in a DOC depending upon the FDA-recognized 
consensus standards and test methods used. For example, FDA recommends that the DOC 
indicate whether the FDA-recognized consensus standards and test methods used were included 
in the testing laboratorys scope of ASCA Accreditation at the time of testing. Example DOCs are 
provided in the standards-specific ASCA Pilot guidance documents. These examples illustrate 
how one DOC might incorporate results from testing using FDA-recognized consensus standards 
and test methods under the ASCA Pilot and outside of the ASCA Pilot. 
3.  Supplemental Documentation to Support a DOC 
FDAs guidance, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions 
for Medical Devices describes when supplemental documentation (e.g., summary test report, 
complete test report) is needed to support a DOC to an FDA-recognized consensus standard.  
Recommended contents for supplemental documentation for testing conducted by an ASCA-
accredited testing laboratory are provided in the standards-specific ASCA Pilot guidance 
documents. Note that the ASCA-accredited testing laboratory provides to the device 
manufacturer all information listed in the relevant ASCA program specifications (including the 
ASCA summary test report). The device manufacturer then includes appropriate supplemental 
documentation (e.g., ASCA summary test report) with its own DOC in a premarket submission 
to FDA. 
XIII.  Processes and Policies for FDA Review Staff 
Use of a conformity assessment scheme to grant ASCA Recognition to accreditation bodies, grant 
ASCA Accreditation to testing laboratories, and communicate with and audit both accreditation 
bodies and testing laboratories provides FDA increased confidence in the methods used and 
results reported by ASCA-accredited testing laboratories when testing is performed within the 
testing laboratorys scope of ASCA Accreditation. 
A.  General Premarket Review Policy 
As part of their participation in the ASCA Pilot, ASCA-accredited testing laboratories agree to 
use methodologies consistent with the FDA-recognized consensus standards and test methods in 
their scope of ASCA Accreditation and the relevant ASCA program specifications. For this 
36 Contains Nonbinding Recommendations 
reason, 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.  However, FDA retains the discretion not to accept determinations 
(i.e., test results) from an ASCA-accredited testing laboratory if FDA finds that a particular 
such determination shall not be so accepted.72 The following are examples of circumstances 
where FDA is likely to question the validity of test methods within a testing laboratorys scope 
of ASCA Accreditation: 
  As part of periodic audits (Refer to Section X.E. and XI.E. of this guidance);73 or 
  If FDA becomes aware of information that would result in suspension or withdrawal of a 
testing laboratorys ASCA Accreditation; or 
  If FDA becomes aware of information that would result in withdrawal of the associated 
accreditation bodys ASCA Recognition; or 
  If FDA becomes aware of information materially bearing on the study conduct or quality 
(e.g., if the testing laboratories under the purview of 21 CFR 58 receive from FDA 
Bioresearch Monitoring Program a warning letter including issues that could potentially 
impact the testing in their scope of ASCA Accreditation); or 
  If FDA becomes aware of information materially relevant to safety or effectiveness for 
the device 74 (e.g., if specific use issues of public health concern are identified for a 
device type during total product lifecycle reviews); or 
  If the ASCA summary test report indicates an issue with the testing or device75 (e.g., 
controls do not work as expected or test results signal a possible issue with safety or 
performance); or 
  If basic administrative information is missing (e.g., product identification information or 
dates of testing); 
  If supplemental documentation to support the DOC (e.g., ASCA summary test report) is 
incomplete; or 
  As noted in the standards-specific ASCA Pilot guidance documents for certain instances. 
In these cases, additional questions may be asked to determine whether the test results can be 
used to support a decision on a premarket submission. 
B.  Impact of Suspension of ASCA Accreditation 
As discussed in Section XI.F.1. of this guidance, FDA will suspend a testing laboratorys ASCA 
Accreditation when specific issues are identified that raise potential concerns with the results 
from that specific laboratory. When evaluating testing results conducted during a period of 
suspension, FDA intends to carefully consider the issues resulting in the suspension as well as 
which FDA-recognized consensus standards and test methods were subject to the temporary 
labeling constraints of the suspension. Depending on the issues resulting in suspension and 
which standards or test methods were suspended, FDA may be unable to rely solely on the 
                                                
72 See section 514(d)(1)(B) of the FD&C Act. 
73 See section 514(d)(2)(A) of the FD&C Act . 
74 See section 514(d)(2)(B) of the FD&C Act. 
75 See section 514 (d)(1)(B) of the FD&C Act. 
37 Contains Nonbinding Recommendations
testing results provided in the premarket submission. In these cases, FDA may need to review 
additional information and/or ask questions to determine whether the test results can be used to 
support a decision on a premarket submission. 
C.  Impact of Withdrawal of ASCA Accreditation 
As discussed in Section XI.G.1. of this guidance, FDA will withdraw a testing laboratorys 
ASCA Accreditation when FDA no longer believes the premarket review benefits of the ASCA 
Pilot are appropriate for testing conducted at the testing laboratory. A manufacturer may still 
include in their premarket submission a DOC for testing conducted at the testing laboratory. In 
these cases, FDA would apply the policies described in FDAs guidance Appropriate Use of 
Voluntary Consensus Standards in Premarket Submissions for Medical Devices, regarding 
review of the associated DOCs (and the need for supplemental documentation to support a 
DOC). 
Withdrawal of a testing laboratorys ASCA Accreditation may indicate the need for FDA to take 
postmarket action. FDA intends to carefully consider the reason for withdrawal when 
determining what postmarket action, if any, is appropriate for closed premarket submissions that 
included testing results from an ASCA-accredited testing laboratory from which ASCA 
Accreditation has been withdrawn. For example, if the nature and severity of the reasons for 
withdrawal might have impacted the testing results supporting the submission decision, FDA 
may engage with the device manufacturer to better understand device performance and 
evaluation, review Medical Device Reports (MDRs) for signs of post market performance issues, 
or conduct other compliance actions. In all cases, FDA intends to carefully weigh the benefits 
and risks to patients when considering what, if any, action should be taken. 
Note that withdrawal of an accreditation bodys ASCA Recognition affects FDA review 
indirectly in that the withdrawal may result in suspension or withdrawal of the associated testing 
laboratorys ASCA Accreditation (Refer to Section XI.F.1. and XI.G.1. of this guidance).
XIV.   Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are subject to review by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3521).
The time required to complete this information collection is estimated76 to average 95 hours per 
response for accreditation bodies and 47 hours for testing laboratories. Send comments regarding 
this burden estimate or suggestions for reducing this burden to:
FDA PRA Staff, 
Office of Operations,
Food and Drug Administration,
PRAStaff@fda.hhs.gov
76Rounded to the nearest whole number.
38 Contains Nonbinding Recommendations
An agency may not conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB control number. 
The OMB control number for this information collection is 0910-0889 (To find the 
current expiration date, search for this OMB control number available at 
https://www.reginfo.gov).
39 Contains Nonbinding Recommendations 
Appendix A: Application for ASCA Recognition 
FDA recommends that an application from an accreditation body seeking ASCA Recognition 
include the following components: 
A.  Administrative Information 
  Organization name and address 
  Designated point of contact: first and last name, title, phone number, and email 
address 
  Alternate designated point of contact: first and last name, title, phone number, and 
email address 
B.  Scope of ASCA Recognition 
Indication of the requested scope of ASCA Recognition from the list of FDA-recognized 
consensus standards and test methods in the ASCA Pilot (more than one standard and test 
method may be identified). 
C.  Information in Support of Competence 
Information demonstrating ability to participate in the ASCA Pilot. 
  Proof of signatory status as International Laboratory Accreditation Cooperation 
(ILAC) MRA with scope that includes testing: ISO/IEC 17025. 
  Confirmation that accreditation body is based in the United States. 
  A current list and description of any accreditation services offered for which the 
scope includes any of the FDA-recognized consensus standards or test methods in 
the ASCA Pilot. 
  An example scope of accreditation that is typically used by the accreditation 
body, and to what extent it will be modified to address accreditation for the 
ASCA Pilot. 
  A detailed description of the process to accredit testing laboratory applicants to 
ISO/IEC 17025 and ASCA program specifications to include awareness, training, 
and accreditation activities. 
  A detailed description of the approach to assess procedures and corrective actions 
as related to the most recent inspection findings noted by FDA Bioresearch 
Monitoring Program per 21 CFR Part 58  Good Laboratory Practice (GLP) for 
Nonclinical Laboratory Studies for testing laboratory applicants with biological 
40 Contains Nonbinding Recommendations 
evaluation of medical device standards and test methods in their scope of 
accreditation.77
  A detailed description of the accreditation bodys approach used to determine 
technical competency of testing laboratories consistent with ASCA program 
specifications. This includes a detailed description of the qualifications for 
technical assessors for the requested scope of ASCA Recognition. A description 
could include resumes, CVs, summary of experience, relevant technical training, 
etc., from personnel already identified. 
  A detailed description of the policy and processes concerning corrective actions 
and the approach for responding to, investigating, and resolving complaints 
against testing laboratories. 
D.  Signed Agreement 
Confirmation that the accreditation body has read, understood, and agrees to adhere to the 
following for its ASCA Pilot-related activities: 
  Maintain scope of signatory status to International Laboratory Accreditation 
Cooperation (ILAC) Mutual Recognition Arrangement (MRA) that includes 
ISO/IEC 17025.  
  Verify conformance with ISO/IEC 17025 and ASCA program specifications 
when accrediting testing laboratories for the ASCA Pilot. 
  Follow the expectations (outlined in the standards-specific ASCA Pilot guidance 
documents) regarding which FDA-recognized consensus standards and test 
methods to assess when accrediting and assessing a testing laboratory for the 
ASCA Pilot. 
  Provide all ASCA Pilot accreditation documentation to FDA upon request. 
  Allow FDA to participate as an observer during the accreditation bodys ILAC 
MRA peer evaluation(s). 
  Allow FDA to participate as an observer during the accreditation bodys 
assessment of a testing laboratory. 
  Commit that all relevant FDA training will be completed by appropriate 
individuals prior to providing any accreditation to testing laboratories under the 
ASCA Pilot. 
  Establish and maintain appropriate communication with FDA. An accreditation 
body should not hesitate to contact FDA regarding the ASCA Pilot. FDA expects 
that appropriate communication includes the following at a minimum: 
  Notification to FDA within five calendar days via email of any changes 
that may impact the accreditation bodys participation (e.g., change to 
scope of signatory status to ILAC MRA). 
                                                
77 As discussed at the public workshop titled Accreditation Scheme for Conformity Assessment of Medical Devices 
to Food and Drug Administration-Recognized Standards, biocompatibility testing conducted under the ASCA Pilot 
will be conducted in accordance with 21 CFR 58 Good Laboratory Practices for Nonclinical Laboratory Studies 
regulations. 
41 Contains Nonbinding Recommendations 
  Notification to FDA within five calendar days via email of any changes 
that may impact the participation of any of the testing laboratories that the 
accreditation body has accredited. 
  Attendance at regularly scheduled teleconferences with FDA as requested. 
  Provision of status updates annually or upon request to FDA including the 
following information regarding the accreditation bodys ASCA Pilot 
activities: 
  Complaint handling; 
  Total number and list of testing laboratories the accreditation body 
has accredited, including dates of accreditation; 
  Number and nature of non-conformities the accreditation body has 
observed during accreditation or auditing of testing laboratories; 
  Number of suspensions issued by the accreditation body for testing 
laboratories; and 
  Results of the accreditation bodys management reviews. 
  Establish and maintain policies and procedures that incorporate feedback from 
FDA. 
  Acknowledge that FDA maintains complete discretion regarding granting ASCA 
Recognition to an accreditation body. FDA may withdraw ASCA Recognition at 
any time. 
  Confirm, to the best of your knowledge, all information submitted to FDA is 
truthful and accurate and that no material fact has been omitted. 
42 Contains Nonbinding Recommendations 
Appendix B: Application for ASCA Accreditation 
FDA recommends that an application from a testing laboratory seeking ASCA Accreditation 
include the following components. If a testing laboratory application will be for multiple testing 
sites, documentation should be clear with respect to the site to which it applies. 
A.  Administrative Information 
  Organization name and address 
  Designated point of contact: first and last name, title, phone number, and email 
address 
  Alternate designated point of contact: first and last name, title, phone number, and 
email address 
B.  Scope of ASCA Accreditation 
Indication of the requested scope of ASCA Accreditation from the list of FDA-recognized 
consensus standards and test methods in the ASCA Pilot (more than one standard and test 
method may be chosen). 
C.  Information in Support of Competence 
Information demonstrating ability to participate in the ASCA Pilot. 
  Proof of testing laboratory accreditation that shows: 
o  The accreditation is from an ASCA-recognized accreditation body. 
o  The scope of ASCA Recognition for the accreditation body includes the scope for 
which they accredited the testing laboratory. 
o  The scope of accreditation provided by the ASCA-recognized accreditation body 
to the testing laboratory matches the testing laboratorys requested scope of ASCA 
Accreditation. 
  A copy of the Index of SOPs and any relevant ASCA test-related documents (e.g., 
SOPs, work instructions, master protocols, test-specific protocols, data collection 
worksheets, training information) applicable to any biocompatibility testing of 
medical device standards and test methods if included in the requested scope of ASCA 
Accreditation. 
D.  Signed Agreement 
Confirmation that the testing laboratory has read, understood, and agrees to adhere to the 
following for its ASCA Pilot-related activities: 
  Conduct testing in accordance with ISO/IEC 17025, and the relevant ASCA 
program specifications 
43 Contains Nonbinding Recommendations 
  Be aware of and consider recommendations made in any relevant FDA guidance 
documents. 
  Abide by the ASCA program specifications to achieve and maintain status as an 
ASCA-accredited testing laboratory. 
  Provide all ASCA Pilot documentation (e.g., complaint logs, issue tracking, test 
procedures) to FDA upon request. 
  Allow FDA to conduct audits upon request; audits may include observations of 
testing activities and documentation review. 
  Establish and maintain appropriate communication with FDA. A testing 
laboratory should not hesitate to contact FDA regarding the ASCA Pilot. FDA 
expects that appropriate communication includes the following at a minimum: 
  Notification to FDA within five calendar days via email of any changes 
that may impact the testing laboratorys participation. 
  Attendance at regularly scheduled teleconferences with FDA as requested. 
Regular interactions between testing laboratories and FDA are intended to 
provide the opportunity for discussions about ASCA implementation 
issues, e.g., training needs, possible improvements and other program-
related topics. FDA plans to hold these teleconferences with testing labs as 
a group, not with individual laboratories.    
  Provision of annual reports of complaint handling to FDA. 
  Commit that all relevant FDA training will be completed by appropriate 
individuals prior to conducting testing under the ASCA Pilot. 
  Ensure that proprietary information is protected per client agreements. 
  Acknowledge that FDA maintains complete discretion regarding granting ASCA 
Accreditation in the ASCA Pilot. FDA may suspend or withdraw ASCA 
Accreditation at any time. 
  Confirm, to the best of your knowledge, all information submitted to FDA is 
truthful and accurate and that no material fact has been omitted. 
44