Welcome to today’s 

FDA/CDRH Webinar

Thank you for your patience while additional 

time is provided for participants to join the call. 

Please connect to the audio portion of the 

webinar now:

U.S. Callers: 888-455-1392

International Callers: 1-773-799-3847 

Passcode: 5276135 
The Accreditation Scheme for Conformity 

Assessment (ASCA) Pilot Program 

Final Guidance Documents 

Webinar

Stacy Cho

Accreditation Scheme for Conformity Assessment (ASCA)

Division of All Hazards Response, Science, and Strategic Partnerships

Office of Strategic Partnership and Technology Innovation

Center for Devices and Radiological Health

October 22, 2020
3

 Objectives

 Background 

 ASCA Pilot

Scheme design

Selected FDA-recognized consensus standards and 

test methods

Roles and responsibilities

Accreditation bodies

Testing laboratories

Device manufacturers

FDA review staff

 Key Implementation Dates

Agenda
4

Objectives

 Understand why the ASCA Pilot was developed

 Understand how the ASCA Pilot was developed

 Understand what the ASCA Pilot is, including:

– Roles and responsibilities of relevant stakeholders

– Process and policies specific to each stakeholder

– Implementation timeline 
5

 During negotiations for the Medical Device User Fee 

Amendments of 2017 (MDUFA IV), the FDA & Industry agreed 

to establish a conformity assessment accreditation scheme for 

testing laboratories that evaluate medical devices according to 

certain FDA-recognized consensus standards and test methods

 The FDA Reauthorization Act of 2017 (FDARA) amended 

section 514 of the FD&C Act by adding a new subsection (d) 

titled, “Pilot Accreditation Scheme for Conformity Assessment”

The ASCA Pilot is established by statute. 
6

Why Was the ASCA Pilot Developed?

 Evidence of conformity to FDA-recognized standards is a thorough and efficient way for a 

manufacturer to address certain questions of safety and/or effectiveness.

 For manufacturers and the FDA to benefit from the efficiency, the FDA must1 have confidence 

in the declaration of conformity (DOC) submitted by device manufacturers in their premarket 

submissions. (See the FDA guidance: Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 

Devices)

 Even with a DOC, FDA may need to request additional information and review supplemental 

documentation given the variability in how testing was conducted.

 Additional FDA review and questions may lead to repeated or revised testing, delays, 

and/or additional costs. 

1. See 514(c)(1)(B) of the FD&C Act
7

How Was the ASCA Pilot Developed?

 Concept of ASCA Pilot Program emerged from discussions between device manufacturers 

and the FDA during MDUFA IV. 

 FDA published a Federal Register notice in May 2017 requesting comments on a set of 

questions regarding development and overall design of the ASCA Pilot Program.

 FDA held public workshop titled “Accreditation Scheme for Conformity Assessment of 

Medical Devices to Food and Drug Administration-Recognized Standards,” May 22-23, 

2018.

 A conformity assessment technical expert from the National Institute of Standards and 

Technology is working with CDRH to develop and implement ASCA Pilot Program.

 FDA received public comment on the draft guidance published September 23, 2019.

 FDA published final guidance on September 25, 2020.
8

The ASCA Pilot is a conformity assessment scheme in which: 

 ASCA-recognized accreditation bodies accredit testing laboratories using 

ISO/IEC 17025 and the ASCA program specifications.

 ASCA-accredited testing laboratories conduct medical device testing in 

accordance with ISO/IEC 17025 and the ASCA program specifications.

 FDA ASCA staff administer the ASCA program including managing participation of 

accreditation bodies and testing laboratories, including suspensions and 

withdrawals. 

What Is the ASCA Pilot?
9

What is the ASCA Pilot?

The ASCA Pilot capitalizes on the relevance of consensus standards in device development 

and regulatory review as well as the existence of a well-established international conformity 

assessment infrastructure. The ASCA Pilot aims to improve efficiency of the premarket 

review process by building confidence in the Declaration of Conformity through the utilization 

of accredited testing laboratories. 
10

ASCA Pilot Process Flow

2. See Figure 1 in The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final Guidance

2
11

Where Is the ASCA Pilot Described?

The draft ASCA Pilot guidance document was split into three final guidance documents 

published on September 25, 2020.

ASCA Pilot Program Guidance:

1. “The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program”

Standards-Specific Guidance:

2. “Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical 

Systems, and Laboratory Medical Equipment – Standards Specific Information for the 

Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program”

3. “Biocompatibility Testing of Medical Devices – Standards Specific Information for the 

Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program”

 A list of the standards and test methods selected for the ASCA Pilot

 ASCA program specifications for those standards and test methods

 Recommended contents for premarket submissions containing testing from an ASCA-accredited testing laboratory

 Example Declarations of Conformity for those standards and test methods

 Example ASCA summary test reports for those standards and test methods
12

How Does the ASCA Pilot Leverage Existing

Conformity Assessment Resources?

 International Laboratory Accreditation Cooperation (ILAC) 

Mutual Recognition Arrangement (MRA)

- ILAC is an international organization for accreditation bodies that 

accredit conformity assessment bodies such as testing laboratories.

- Accreditation bodies that are signatories to the ILAC MRA are peer 

evaluated to ISO/IEC 17011 to demonstrate their competence.

- ISO/IEC 17011 includes specifications for accreditation bodies.

The ASCA Pilot is designed to maximize the use of existing frameworks and arrangements.

Existing Framework:
13

How Does the ASCA Pilot Leverage Existing

Conformity Assessment Resources?

 ILAC MRA signatory status is a qualification for accreditation body participation. 

 The ASCA Pilot leverages the ILAC MRA policies and processes by reviewing 

accreditation body peer evaluation reports and/or participating as an observer during 

these activities.

 The ASCA Pilot leverages ISO/IEC 17011 policies and procedures by reviewing 

testing laboratory assessment reports and/or participating as an observer during 

these activities. 

In the ASCA Pilot:
14

How Does the ASCA Pilot Leverage Existing

Conformity Assessment Resources?

 ISO/IEC 17025 contains specifications for laboratories to operate 

competently and generate valid results. 

The ASCA Pilot is designed to maximize the use of existing frameworks and arrangements.

Existing Framework:
15

How Does the ASCA Pilot Leverage Existing

Conformity Assessment Resources?

 ASCA-recognized accreditation bodies accredit testing laboratories using ISO/IEC 

17025 and ASCA program specifications. 

 ASCA-accredited testing laboratories conduct testing in accordance with ISO/IEC 

17025 and the ASCA program specifications. 

3. See Section VIII.B. of The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final Guidance

In the ASCA Pilot3:
16

Which FDA-Recognized Consensus Standards and 

Test Methods Are In the ASCA Pilot? 

In accordance with the MDUFA IV commitment letter, the standards and test 

methods in the ASCA Pilot:

 Include both cross-cutting (horizontal) and device-specific (vertical) standards.

 Are of public health significance.

 Have or are able to provide the means for establishing acceptance.
17

Basic Safety and Essential Performance of Medical 

Electrical Equipment, Medical Electrical Systems, 

and Laboratory Medical Equipment

IEC 60601/80601 series of standards recognized by FDA at the time of final

guidance publication:

 ANSI/AAMI ES 60601-1

 IEC and US adopted collaterals [60601-xx]

 IEC 60601-2-xx and the IEC or ISO 80601-2-xx particulars
18

Biocompatibility Testing of Medical Devices 
19

ASCA Program Specifications

ISO/IEC 17025: General requirements for the 

competence of testing and calibration 

laboratories, 3rd Edition (2017)

ASCA Program Specifications for the 

Biological Evaluation of Medical Devices 

ISO/IEC 17025 served as foundation for ASCA program specifications found in the standardsspecific ASCA Pilot guidance documents. The working group that developed these specifications 

consisted of technical experts and personnel from FDA and NIST. 

ASCA Program Specifications for the Basic 

Safety and Essential Performance of Medical 

Electrical Equipment, Medical Electrical 

Systems, and Laboratory Equipment
20
21

Policies and Processes for Accreditation Bodies

Role 

 ASCA-recognized accreditation bodies 

accredit testing laboratories using the 

specifications of ISO/IEC 17025 and the 

ASCA program specifications associated 

with each FDA-recognized consensus 

standard and test method in their scope of 

ASCA Recognition4

Qualifications 

 Signatory status of Testing: ISO/IEC 17025 

to the International Laboratory 

Accreditation Cooperation (ILAC) Mutual 

Recognition Arrangement (MRA)

 Based in the United States

 Agreed to terms of participation 

4. See Section X. of The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final Guidance
22

Policies and Processes for Accreditation Bodies

 Accreditation Body 

drafts application for 

ASCA Recognition 

consistent with 

Appendix A of ASCA 

Pilot program 

guidance 

 Accreditation body 

submits application 

via email to 

ASCA@fda.hhs.gov

 FDA reviews 

application 

within 60 days

 FDA notifies 

accreditation body 

of final decision 

via e-mail and if 

applicable, of any 

issues precluding 

ASCA Recognition

Application Process 
23

Policies and Processes for Accreditation Bodies

FDA intends to periodically audit accreditation bodies to ensure that they are adequately fulfilling 

program expectations.

Level 2 Audit

 What: FDA reviews a copy of 

the most recent ILAC peer reevaluation report and 

participates as an observer 

during next scheduled ILAC 

peer re-evaluation.

 Why: Level 1 audit insufficient 

(e.g., persistent issues with 

testing laboratories accredited 

by an accreditation body)

Level 1 Audit 

 What: FDA reviews a copy of 

the most recent ILAC peer reevaluation report

 Why: periodic assessment to 

ensure adherence to program 

expectations

Level 3 Audit

 What: FDA initiates on-site or 

remote audit of accreditation 

body outside of ILAC MRA 

peer evaluation schedule 

 Why: Level 1 and Level 2 

audits insufficient (e.g., public 

health concern regarding 

safety or a device)
24

Policies and Processes for Accreditation Bodies

Why?

FDA no longer has confidence in the accreditation body’s ability to adequately fulfill its role in the 

ASCA Pilot; for example: 

 Violation of law or violation of policies outlined in this guidance or other standards-specific ASCA 

Pilot guidances 

 Failure to correct nonconformity

 Failure to adhere to signed agreement

 Information materially bearing on safety or effectiveness of a device that reasonably relates to the 

accreditation body

 Withdrawal or suspension of ASCA Accreditation for a testing laboratory that was accredited by the 

accreditation body

5. See Section X.F. of The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final Guidance

Withdrawal of ASCA Recognition cancels the accreditation body’s full scope of ASCA Recognition

and removes them from the ASCA Pilot entirely5. 
25

Policies and Processes for Accreditation Bodies

How?

 FDA sends a withdrawal letter via email to the contact on record for the accreditation body

 Accreditation body voluntarily requests withdrawal by submitting email to 

ASCA@fda.hhs.gov

In either case

 FDA notifies ASCA-accredited testing laboratories accredited for the ASCA Pilot by the 

now-withdrawn accreditation body

 Accreditation body submits new application for ASCA Recognition to participate again
26

Policies and Processes for Testing Laboratories

Role 

 ASCA-accredited testing laboratories 

perform testing in accordance with the 

specifications of ISO/IEC 17025 and the 

ASCA program specifications associated 

with each FDA-recognized consensus 

standard and test method in their scope of 

ASCA Accreditation6

 After testing is complete, ASCA-accredited 

testing laboratories provide the information 

listed in the relevant ASCA program 

specifications (including an ASCA 

summary test report) to the device 

manufacturer

Qualifications 

 Requested scope of ASCA Accreditation 

consistent with scope of accreditation 

provided by an ASCA-recognized 

accreditation body

 Agreed to terms of participation 

6. See Section XI. of The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final Guidance
27

Policies and Processes for Testing Laboratories 

 Testing laboratory 

drafts application for 

ASCA Accreditation 

consistent with

Appendix B of ASCA 

Pilot program 

guidance 

 Testing laboratory 

submits application 

via email to 

ASCA@fda.hhs.gov

 FDA reviews 

application 

within 60 days

 FDA notifies testing 

laboratory of final 

decision via email 

and if applicable, of 

any issues 

precluding ASCA 

Accreditation

Application Process 
28

Policies and Processes for Testing Laboratories

FDA intends to periodically audit testing laboratories to ensure that they are adequately fulfilling 

program expectations.

Level 2 Audit

 What: FDA reviews a copy of 

the most recent assessment 

report and participates as an 

observer during next 

scheduled assessment of the 

testing laboratory by the 

accreditation body

 Why: Level 1 audit insufficient 

(e.g., concerning trend in 

testing laboratory’s complaint 

logs)

Level 1 Audit 

 What: FDA reviews a copy of 

the most recent assessment 

report

 Why: periodic assessment to 

ensure program expectations

Level 3 Audit

 What: FDA initiates on-site or 

remote audit of the testing 

laboratory outside of the 

assessment schedule 

established by the 

accreditation body

 Why: Level 1 and Level 2 

audits insufficient (e.g., public 

health concern regarding 

safety or a device)
29

Policies and Processes for Testing Laboratories

Why?

FDA identifies potential concerns regarding the testing laboratory’s ability to adequately 

fulfill its role in the ASCA Pilot; for example: 

 Existence of a nonconformity

 Inadequate completion of training or communication with FDA

 Information materially bearing on safety or effectiveness of a device that reasonably 

relates to the testing laboratory

 Withdrawal of ASCA Recognition from the accreditation body that accredited the testing 

laboratory for the ASCA Pilot

7. See Section XI.F. of The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final Guidance

Suspension of ASCA Accreditation puts temporary constraints on one or more FDA-recognized consensus 

standards or test methods in the testing laboratory’s scope of ASCA Accreditation while issues are addressed7.
30

Policies and Processes for Testing Laboratories

How?

 FDA initiates suspension by sending a letter via email to the contact on record for the 

testing laboratory 

 Testing laboratory voluntarily requests suspension by submitting email to 

ASCA@fda.hhs.gov

In either case

 FDA notifies the accreditation body that accredited the lab for the ASCA Pilot

 A testing laboratory requests suspension be lifted by sending a response to 

ASCA@fda.hhs.gov
31

Policies and Processes for Testing Laboratories 

Why?

FDA no longer has confidence in the testing laboratory’s ability to adequately fulfill its role in the 

ASCA Pilot; for example: 

 Violation of law or violation of policies outlined in this guidance and other standards- specific ASCA Pilot guidances

 Failure to correct nonconformity

 Failure to adhere to signed agreement

 Information materially bearing on safety or effectiveness of a device that reasonably 

relates to the testing laboratory

 Withdrawal of ASCA Recognition from the accreditation body that accredited the testing 

laboratory for the ASCA Pilot

8. See Section XI.F. of The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final Guidance

Withdrawal of ASCA Accreditation cancels the testing laboratory’s full scope of ASCA 

Accreditation and removes them from the ASCA Pilot entirely8. 
32

Policies and Processes for Testing Laboratories 

How?

 FDA initiates withdrawal by sending withdrawal letter via email to contact on record

 Testing laboratory voluntarily requests withdrawal by submitting email to ASCA@fda.hhs.gov

In either case

 FDA notifies the accreditation body that accredited the lab for the ASCA Pilot

 Testing laboratory submits new application for ASCA Accreditation to participate again
33

 Device manufacturers may voluntarily choose to use an ASCA-accredited testing 

laboratory to conduct testing included in a premarket submission9

 List of ASCA-accredited testing laboratories will be on the ASCA FDA website.

Policies and Processes for Device Manufacturers 

9. See Section XII. of The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final Guidance
34

 Device manufacturers are responsible for ensuring FDA-recognized consensus 

standards are selected and used appropriately10

 Considerations for development of a test plan for testing at an ASCA-accredited 

testing laboratory include:

Policies and Processes for Device Manufacturers 

- Other relevant FDA guidance 

documents (e.g., device type 

guidance, scientific area guidance, 

submission type guidance)

- Other FDA-recognized consensus 

standards (e.g., collateral and 

particular standards for basic 

safety and essential performance) 

- Impact of deviations from FDArecognized consensus 

standards

- Testing outside a testing 

laboratory’s scope of ASCA 

Accreditation 

10. See the FDA guidance: Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
35

Device manufacturers are responsible for documenting how testing supports premarket 

authorization, even when testing is performed at an ASCA-accredited testing laboratory.

Policies and Processes for Device Manufacturers 

Declaration of Conformity

 DOC plus ASCA 

Accreditation status for the 

testing laboratory 

 See example DOCs

* See the FDA guidance: Appropriate Use of 

Voluntary Consensus Standards in 

Premarket Submissions for Medical Devices

Cover Letter

 “ASCA” 

 Name(s) and location(s) of 

the testing laboratory(ies) 

ASCA Identification 

Number(s) 

 FDA-recognized consensus 

standard(s) and test 

methods

Supplemental 

Documentation

 See standards-specific 

ASCA Pilot guidance 

documents for example 

ASCA summary test reports
36

Policies and Processes for FDA Review Staff

 FDA intends to rely on the results from 

ASCA-accredited testing laboratories for 

the purposes of premarket review without 

the need for additional information related 

to conformance with a standard

 FDA does not intend to question the 

validity of test methods within a testing 

laboratory’s scope of ASCA Accreditation 

 The ASCA Pilot’s conformity 

assessment scheme provides FDA 

increased confidence in the methods 

used and results reported by ASCAaccredited testing laboratories when 

testing is performed within the testing 

laboratory's scope of ASCA 

Accreditation11

11. See Section XIII. of The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program - Final Guidance
37

Policies and Processes for FDA Review Staff 

Example of Exceptions

(not exhaustive)

 As part of periodic audits 

 If FDA becomes aware of information that would result in suspension or 

withdrawal of a testing laboratory’s ASCA Accreditation

 If FDA becomes aware of information that would result in withdrawal of the 

associated accreditation body’s ASCA Recognition

 If FDA becomes aware of information materially bearing on the study 

conduct or quality

 If the ASCA summary test report indicates an issue with the testing or device
38

Policies and Processes for FDA Review Staff 

What if ASCA Accreditation was suspended at the time of testing?

 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.12

 FDA intends to carefully consider the issues resulting in suspension as well as which FDArecognized consensus standards and test methods were subject to the temporary labeling 

constraints of the suspension.

12. See the FDA guidance: Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
39

Policies and Processes for FDA Review Staff 

What if ASCA Accreditation was withdrawn at the time of testing?

 FDA applies the policies applicable to testing from labs that never received ASCA 

Accreditation. 

 FDA intends to carefully consider the nature and severity of the reasons for withdrawal of 

ASCA Accreditation when determining what, if any, postmarket action is needed for closed 

premarket submissions that included testing results from testing laboratories whose ASCA 

Accreditation has been withdrawn. 
40

Accreditation Bodies

Testing Laboratories

Device Manufacturers

FDA

TEAMWORK
41

 FDA intends to publish a list of ASCA-recognized accreditation bodies on November 25, 2020

 Applications received on or before November 4, 2020 will be considered for publication on this initial list

 Applications received after November 4, 2020 will be reviewed in the order received and the list of ASCArecognized accreditation bodies will be updated as appropriate 

 FDA intends to publish an initial list of ASCA-accredited testing laboratories that will be 

updated throughout the Pilot. 

 FDA will update their web page to include the anticipated publication date for the initial list of ASCAaccredited testing laboratories and a date by which FDA should receive a testing laboratory's application 

in order for the organization to be considered for the initial list.

Key Application Dates

All dates and additional information, including how to sign up, are available on the ASCA website. For questions, email ASCA@fda.hhs.gov. 
42

Appendix: Additional FDA Engagement

Accreditation Body Training Sessions 

 What Overview of ASCA Pilot policies and 

processes for accreditation bodies

When Oct 29, 2020; 1-5 pm 

Who Accreditation body program managers 

 What Detailed instruction on how to use the ASCA 

program specifications during accreditation of 

testing laboratories for the ASCA Pilot 

When Oct 30, 2020 – Nov 3, 2020; 1-5 pm

Who Technical assessors who will provide subject 

matter expertise during accreditation of testing 

laboratories for the ASCA Pilot

All dates and additional information, including how to sign up, are available on the ASCA website. For questions, email ASCA@fda.hhs.gov. 

Accreditation Bodies
43

Appendix: Additional FDA Engagement

 Biocompatibility Testing Laboratory Q&A 

Session

What Brief introduction to biocompatibility 

standards-specific ASCA Pilot 

guidance document followed by 

audience Q&A

When November 23, 2020

All dates and additional information, including how to sign up, are available on the ASCA website. For questions, email ASCA@fda.hhs.gov. 

 Basic Safety and Essential Performance Testing 

Laboratory Q&A Session

What Brief introduction to basic safety and 

essential performance standardsspecific ASCA Pilot guidance document

followed by audience Q&A

When November 16, 2020

Testing Laboratories 
44

 Final Guidance Document Links:

 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/accreditation-schemeconformity-assessment-asca-pilot-program

 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/basic-safety-andessential-performance-medical-electrical-equipment-medical-electrical-systems-and

 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biocompatibility-testingmedical-devices-standards-specific-information-accreditation-scheme

 ASCA Webpage Link:

https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/accreditationscheme-conformity-assessment-asca

 The FDA-Recognized Consensus Standards Database Link:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

 Appropriate Use Guidance Document: https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarketsubmissions-medical-devices

Resources
45

Questions?

Standards and Conformity Assessment Program, ASCA Pilot: 

ASCA@fda.hhs.gov

Division of Industry and Consumer Education: DICE@fda.hhs.gov

Slide Presentation, Transcript and Webinar Recording will be available at: 

Heading: How to Study and Market Your Device; Subheading: Standards 

http://www.fda.gov/training/cdrhlearn

Please complete a short survey about your FDA CDRH 

webinar experience. The survey can be found here

immediately following the conclusion of the live webinar