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. Dial: 1-888-455-1392

International Dial: 1 -773 - 799 - 3847 

Conference Number: PWXW2150271 

Passcode:4055554
The ASCA Pilot: Streamlining Conformity 

Assessment in Device Submissions

Angela DeMarco, M.S. 

Office of Product Evaluation and Quality 

Shuliang Li, Ph.D. 

Eric Franca, Ph.D. 

Office of Strategic Partnerships and Technology Innovation

Center for Devices and Radiological Health

May 20, 2021
3

Agenda

• Accreditation Scheme for Conformity Assessment 

(ASCA) Pilot update 

• Premarket submission preparation with ASCA testing 

• Biocompatibility update 

• Basic safety and essential performance update 
4

What is the ASCA Pilot?

• Voluntary program

• Leverages a well - established international conformity 

assessment infrastructure 

• Capitalizes on voluntary consensus standards in device 

development and review 

• ‘Puts standards to work’ on both individual and international 

levels 
5

Why Use ASCA?

• Enhances the FDA’s confidence in test methods and results 

• Decreases need for additional information related to 

conformance with a standard 

• Promotes consistency, predictability, and efficiency in medical 

device review 

• Least burdensome approach to conformity assessment 

• Patients have access to safe, effective, and high - quality 

medical devices 

ASCA Goal: Enhance the use of conformity assessment 

in premarket review
6

How ASCA Works

6

1. FDA grants ASCA 

Recognition to 

qualified 

accreditation bodies

2. Test labs obtain 

ASCA Accreditation 

from the FDA

3. Device 

manufacturers select 

ASCA-accredited test 

lab 

4. ASCA-accredited 

test lab conducts 

testing and provides 

relevant information 

to manufacturer

5. Manufacturer 

includes declaration of 

conformity and ASCA 

Summary Test Report 

in submission 

6. FDA conducts 

review per the 

ASCA Pilot 

guidances
7

ASCA Pilot Guidances

• Program 

– Accreditation Scheme for Conformity 

Assessment (ASCA) Pilot Program 

• Standards-Specific

– Biocompatibility Testing of Medical 

Devices 

– Basic Safety and Essential 

Performance of Medical Electrical 

Equipment, Medical Electrical 

Systems, and Laboratory Medical 

Equipment

7
8

ASCA Progress 

Apr 2021: (53) 

test labs were 

granted ASCA 

Accreditation; 

manufacturers 

may engage 

Nov 2020: Five 

accreditation 

bodies received 

ASCA 

Recognition

Sept 2020: Final 

guidances 

published

Sept 2019: Draft 

guidance 

published
Premarket Submission Preparation 

With ASCA Testing

9
10

1

Identify ASCA Pilot standards to be cited

2

Develop and agree on test plan with an 

ASCA-accredited test lab

3

Plan submission elements

4

Obtain results and Summary Test Report(s) 

from test lab

5

Prepare FDA submission 

Steps
11

• Check ASCA web page on FDA.gov for ASCA

standards 

• Consult Recognized Consensus Standards 

database 

− Supplementary Information Sheet (SIS) 

− Standard’s extent of recognition and edition 

*** When voluntary consensus standards are used, manufacturers are responsible for 

selecting and using FDA - recognized consensus standards and test methods 

appropriately ***

1. Identify ASCA Pilot Standards to be Cited
12

• Select an ASCA - accredited test lab 

• Develop and agree on test plan 

– Note: Manufacturer is responsible for test plan(s) 

– Considerations: 

• Relevant FDA guidance documents 

• The FDA - recognized consensus standards 

• Testing outside a test lab’s scope of ASCA Accreditation

2. Develop and Agree on Test Plan with

ASCA-accredited Test Lab
13

*** Device manufacturers are responsible for documenting how testing 

supports premarket authorization, even for ASCA Pilot submissions ***

13

Declaration of 

Conformity (DOC) 

Ø Manufacturer’s 

responsibility 

Ø ASCA Accreditation status 

for the test lab 

Ø See suggested content in 

guidance 

Cover Letter 

Ø States that submission is 

for ASCA Pilot 

Ø Name, location and IDs of 

test lab(s) 

Ø The FDA - recognized 

consensus standard(s) 

and test methods used

ASCA Summary Test 

Report

Ø See standards - specific 

ASCA Pilot guidance 

documents for examples 

3. Plan Submission Elements
14

14

Cover Letter 

Ø States that submission is 

for ASCA Pilot 

Ø Name, location and IDs of 

test lab(s) 

Ø The FDA - recognized 

consensus standard(s) 

and test methods used

ASCA Summary Test 

Report

Ø See standards - specific 

ASCA Pilot guidance 

documents for examples 

Declaration of 

Conformity (DOC) 

Ø Manufacturer’s 

responsibility 

Ø ASCA Accreditation status 

for the test lab 

Ø See suggested content in 

guidance 

3. Plan Submission Elements
15

15

Cover Letter 

Ø States that submission is 

for ASCA Pilot 

Ø Name, location and IDs of 

test lab(s) 

Ø The FDA - recognized 

consensus standard(s) 

and test methods used

ASCA Summary Test 

Report

Ø See standards - specific 

ASCA Pilot guidance 

documents for examples 

Declaration of 

Conformity (DOC) 

Ø Manufacturer’s 

responsibility 

Ø ASCA Accreditation status 

for the test lab 

Ø See suggested content in 

guidance 

3. Plan Submission Elements
16

Elements of a DOC

• Name and address of applicant/sponsor responsible for 

DOC 

• Product/device identification 

• Statement of conformity 

• List of standards to which DOC applies 

• The FDA recognition number for each standard

Please see ISO/IEC 17050-1:2004(en): Conformity assessment - supplier's declaration of conformity - Part 1: General 

requirements and the FDA’s guidance: Appropriate Use of Voluntary Consensus Standards in Premarket Submissions 

for Medical Devices
17

Elements of a DOC, cont’d

• Date and place of issuance of DOC 

• Signature, printed name, and function of applicant/sponsor 

responsible for DOC 

• Any limitation on validity of DOC (for example, how long 

declaration is valid, what was tested, or concessions made 

about testing outcomes) 

• Supplemental documentation 

Please see ISO/IEC 17050-1:2004(en): Conformity assessment - supplier's declaration of conformity - Part 1: General 

requirements and the FDA’s guidance: Appropriate Use of Voluntary Consensus Standards in Premarket Submissions 

for Medical Devices
18

18

Cover Letter 

Ø States that submission is 

for ASCA Pilot 

Ø Name, location and IDs of 

test lab(s) 

Ø The FDA - recognized 

consensus standard(s) 

and test methods used

ASCA Summary Test 

Report

Ø See standards - specific 

ASCA Pilot guidance 

documents for examples 

Declaration of 

Conformity (DOC) 

Ø Manufacturer’s 

responsibility 

Ø ASCA Accreditation status 

for the test lab 

Ø See suggested content in 

guidance 

3. Plan Submission Elements
19

ASCA Summary Test Reports

• Supplemental documentation for ASCA submissions 

• Developed by a panel of FDA knowledgeable staff 

• Examples found in appendixes of the two ASCA

standards - specific guidances 
20

• Test lab 

–Conducts testing 

–Sends complete test reports and ASCA Summary Test 

Report(s) to manufacturer 

4. Obtain Results and Summary Test 

Report(s) from Test Lab
21

Assemble the following: 

• Cover letter with ASCA-specific information

• Declaration of conformity 

• Summary Test Report 

– Generally don’t need complete test reports 

– Manufacturer should not modify Summary Test Reports from testing 

laboratories 

• All other submission requirements

5. Prepare FDA Submission
22

Using eSTAR

• Includes ASCA - specific information 

• Voluntary, currently its own pilot for 510(k) submissions 

• Benefits: 

– Fillable PDF 

– Will tell you if anything is missing 

– Includes ASCA option for eligible tests 
23

Using eSTAR 

If you select the ASCA

option, you will be prompted 

to include administrative 

information 

23
24

Summary

The ASCA Pilot: 

• Increases consistency and predictability in assessing 

conformance with the FDA - recognized standards 

• Reduces regulatory burden by streamlining conformity 

assessment 

• Ensures patient access to safe, effective devices 
25

Summary

Five steps to prepare a submission with ASCA testing 

1. Identify the standard(s) 

2. Agree on test plan 

3. Plan submission elements 

4. Obtain results and ASCA Summary Test Reports 

5. Prepare the FDA submission 

ASCA - specific elements of a device submission 

1. Cover letter with ASCA - specific information 

2. Declaration of conformity 

3. Summary Test Reports
The ASCA Pilot: Biocompatibility

Shuliang Li, Ph.D. 

ASCA Testing Laboratory Lead, Biocompatibility 

Standards and Conformity Assessment Program 

Center for Devices and Radiological Health 

U.S. Food and Drug Administration
27

Topics

• ASCA Pilot biocompatibility testing 

• Declarations of conformity (DOCs) for biocompatibility 

standards 

• ASCA Pilot biocompatibility Summary Test Reports 
28

FDA Recognized Consensus Standard Test Method(s)

ISO 10993-4 Complement Activation using a U.S. marketed ELISA kit

ISO 10993-4 and ASTM F756 Direct and Indirect Hemolysis

ISO 10993-5 MEM Elution Cytotoxicity

ISO 10993-10 Dermal Irritation, Intracutaneous Reactivity Irritation, and 

Closed Patch Sensitization 

ISO 10993-10 and ASTM F720 Guinea Pig Maximization Sensitization

ISO 10993-11 Acute Systemic Toxicity

ISO 10993-11 and USP 151 Material-Mediated Pyrogenicity

ISO 10993-12 Sample preparation for all test types ASCA Pilot Standards: Biocompatibility

*** Please see the ASCA biocompatibility standards - specific guidance for a full 

listing of standards and test methods and visit the Recognized Consensus 

Standards database for more information ***
29

Selection of Biocompatibility Testing and 

Testing Laboratory

• ASCA does not change the paradigm for the development of a biocompatibility 

evaluation: manufacturers work with testing laboratories to develop a testing 

plan 

• To determine biocompatibility evaluation endpoints, refer to Attachment A of the 

general FDA biocompatibility guidance 

– Use of International Standard ISO 10993 - 1, "Biological evaluation of medical 

devices - Part 1: Evaluation and testing within a risk management process” 

• All biocompatibility testing under the ASCA Pilot should be conducted according 

to 21 CFR 58 Good Laboratory Practices for Nonclinical Laboratory Studies 

regulations 
30

Devices Excluded from ASCA Pilot

• Excluded from the ASCA Pilot biocompatibility scope: 

– Devices requiring customized sample preparation and/or testing 

methodologies 

– Absorbable devices 

– In situ polymerizing devices 

– Liquid devices 

– Creams, gels, hydrogel devices 

– Devices containing nanomaterials 
31

Declarations of Conformity for 

Biocompatibility Standards
32

Example ASCA DOC for Biocompatibility
33

ASCA DOC for 

Biocompatibility 

Standards, page 1

ISO 10993 - 10 • Clause 6.3 Primary skin irritation test • Clause 6.4 Intracutaneous reactivity • Clause 7.5 Guinea pig maximization test 

(GPMT) 

• Clause 7.6 Closed - patch test (Buehler test) 

✓

✓
34

ASCA DOC for 

Biocompatibility 

Standards, page 2

✓✓

✓
35

ASCA DOC for 

Biocompatibility 

Standards, page 3
36

ASCA Biocompatibility 

Summary Test Reports
37

Biocompatibility ASCA Summary Test Report

• Test labs provide both complete test reports and ASCA Summary Test Reports 

to manufacturers 

• The FDA generally will accept Summary Test Reports from ASCA - accredited 

test labs without the need to review complete test reports 

• A complete test report may be needed when: 

– “Other” option is selected for test article preparation 

– Deviations/amendments 

– Changes in color/turbidity or particles in the test article and/or extract OR there was 

swelling/degradation of the test article 

– Results (including controls) are outside the range as specified in the ASCA guidance for 

biocompatibility testing 

*** Note: review the footnotes in the example Summary Test Reports (Appendix B - J 

in the ASCA biocompatibility guidance) for more information ***
38

Biocompatibility ASCA Summary Test Report

Footnotes outline 

when a complete test 

report may be needed
39

Summary

• Consult the FDA’s general biocompatibility guidance to determine 

appropriate endpoints 

• The manufacturer and ASCA - accredited test lab should collaborate to 

develop the test plan 

• Comply with 21 CFR 58 GLP 

• Submit the declaration of conformity with the ASCA Summary Test 

Report(s) 

– Be aware when a complete test report might be needed 
The ASCA Pilot: Basic Safety and 

Essential Performance 

Eric Franca, Ph.D. 

ASCA Testing Laboratory Lead, Basic Safety and Essential Performance 

Standards and Conformity Assessment Program 

Center for Devices and Radiological Health 

U.S. Food and Drug Administration
41

Topics

• Recommendations for ASCA Accreditation 

applicants 

• Test development and planning 

• Summary Test Reports 
42

ASCA Pilot Standards: 

Basic Safety and Essential Performance

Standard Standard Title

ANSI/AAMI 

60601-1

Medical electrical equipment – Part 1: General requirements for basic safety and 

essential performance (along with the FDA-recognized collateral and particular 

standards in the IEC/ISO 60601-80601 family)

IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and 

laboratory use – Part 1: General requirements (along with the FDA-recognized 

particular standards in the IEC 61010 family)

*** Please see the ASCA basic safety and essential performance standards - specific 

guidance for a full listing of standards and test methods and visit the Recognized 

Consensus Standards database for more information ***
Recommendations for ASCA

Accreditation Applicants

43
44

What to Do

• Test labs should: 

– Review and understand our guidance documents 

– Submit a complete application including: 

• Administrative information about the test lab site 

• A scope of accreditation from an ASCA - recognized accreditation body 

with accreditation to ISO/IEC 17025 and ASCA Pilot specifications 

• Signed agreement (see Appendix B of the ASCA Pilot program guidance) 

Note: helpful information can be found in the AAMI CR500:2019 Basic Introduction to the 

IEC 60601 Series report at www.aami.org 
45

What to Do

• Understand that the FDA reviews ASCA Accreditation 

applications as they are received 

– We intend to complete review within 60 days 

– The ASCA - accredited test lab list on our web page will be updated as 

new labs receive ASCA Accreditation 

• Understand that the scope of ASCA Accreditation is limited to 

the relevant scope of accreditation from its accreditation body

– Clauses and methods excluded in relevant standards on the scope of 

accreditation will also be excluded in the scope of ASCA Accreditation 
46

What to Avoid

• Test labs should avoid: 

– Sending an incomplete application 

• Include all the elements described in ASCA Pilot guidances 

• Ensure the scope of accreditation from your accreditation body includes 

assessment to ISO/IEC 17025 and the ASCA Pilot specifications 

– Requesting ASCA Accreditation for standards: 

• Not included in the ASCA Pilot 

• Not listed in the ASCA section of the scope of accreditation from your 

accreditation body 

– Submitting a separate application for a satellite lab – the satellite lab is 

included as part of the main lab

• Do clarify in your submission that there is a satellite lab associated with the main 

test lab location, for our information 
47

If ASCA Accreditation is Granted

• If your test lab is granted ASCA Accreditation: 

– We will post your lab information on the ASCA web page 

• If you prefer generic lab contact information, please specify in your 

application 

– Though the listing on the ASCA web page does not include the 

versions/editions of standards, remember to only test to standards to 

which you have been accredited 

– Note any exclusions defined in the scope of accreditation from your 

accreditation body 
Test Plan Development

48
49

Who is Responsible for the Test Plan?

• Manufacturers are responsible for the test plan and the 

appropriate selection and use of recognized consensus 

standards and test methods 

• However, ASCA - accredited test labs often have expertise 

which exceeds manufacturers’ 

• Manufacturers and ASCA test labs should work together to 

develop a test plan
50

What to Consider

• Consult the FDA’s Recognized Consensus Standards database and Supplementary Information 

Sheets (SIS) 

– Some standards in the ASCA Pilot are only partially recognized 

– The SIS provides rationales and helpful references, including other relevant FDA guidances 

• Review the ASCA Pilot Basic Safety and Essential Performance guidance and other relevant 

guidances 

– Examples of potentially relevant guidances (not an exhaustive list): 

• Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically - Powered Medical Devices 

(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/information-support-claimelectromagnetic-compatibility-emc-electrically-powered-medical-devices) 

• Design Considerations for Devices Intended for Home Use (https://www.fda.gov/regulatory-information/search-fda-

•

guidance - documents/design - considerations - devices - intended -home-use

Laser Products - Conformance with IEC 60825 - 1 Ed. 3 and IEC 60601 - 2 - 22 Ed. 3.1 https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/laser-products-conformance-iec-60825-1-ed-3-and-iec-60601-2-22-ed-

•

31 - laser - notice - 

Pulse Oximeters 

no-56

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pulse-oximeterspremarket-notification-submissions-510ks-guidance-industry-and-food-and-drug
51

51
52

52
53

What if the Test Lab has Concerns with 

a Manufacturer’s Proposed Test Plan?

• ASCA - accredited test lab should exercise its independent 

judgment concerning the application of a standard and 

conduct of conformity assessment activities 

• Test labs should communicate concerns with the test plan to 

the manufacturer in early interactions 

• If concerns cannot be resolved with the manufacturer, test 

labs should detail the issues in the Summary Test Report 
Summary Test Reports

54
55

Summary Test 

Report, page 1

55
56

Clauses Tested

1. Clauses Deemed Applicable 

 ̈ All clauses were deemed applicable. 

 ̈ The following clauses were deemed not applicable. 

List of and rationale for any clauses identified as not applicable

2. Clauses Tested

 ̈ All clauses were tested

 ̈ The following clauses were not tested

List of any clauses not tested.

3. Clauses with Failing Results 

 ̈ No clauses had failing results

 ̈ The following clauses had failing results

List of any clauses with failing results. Descriptions of any failures.

Modification(s) to Test Methods and/or Acceptance Criteria

 ̈ No test methods specified in the standard were modified

 ̈ No acceptance criteria specified in the standard were modified

 ̈ One or more test methods or acceptance criteria were modified

List of test methods and/or acceptance criteria that were modified. Appropriate supporting 

documents should be attached to this ASCA summary test report including the test plan and 

procedure, acceptance criteria that were applied, and the test results.

Additional Testing Performed to Demonstrate Conformity with the Standard

 ̈ No additional testing was performed other than that specified in the standard

 ̈ Additional testing was performed as specified by the manufacturer to address a 

hazardous situation not specifically addressed by the standard

Description of additional testing performed to address a hazardous situation not specifically 

addressed by the standard. Appropriate supporting documents are attached to this ASCA 

summary test report including the test plan and procedure, acceptance criteria that were 

applied, and the test results.

Device Configuration(s) and Mode(s) of Operation 

Description of how device was configured including modes of operation used during testing. Summary Test 

Report, page 2
57

Summary Test 

Report, page 3

57

Observations and Degradations During Testing

 ̈ Observations and degradations were NOT found during testing 

 ̈ Observations and degradations were found, but deemed acceptable based on the pass/fail 

criteria identified by the device manufacturer

Description of observations and degradations of concern to the testing laboratory but deemed 

acceptable. Example include:

· Instances of device showing unexpected behaviors (e.g., display of incorrect values, 

display of error messages, device or components need to be restarted, if the device or 

components restart unexpectedly). 

· Instances of device or components being unexpectedly damaged and need replacement 

or other intervention to return to normal operation.

This list should capture unexpected events. As an example, an error message would be 

unexpected (and therefore would be listed) during EMC testing when a valid input is present; 

conversely, the same error message would be expected (and therefore would not be listed) 

during a test that feeds an out-of-range input to verify the function of input errors. Any

unexpected behavior is reported even if acceptable per the pass/fail criteria. If the unexpected 

behavior is listed as possible in the labeling (e.g., “the device may restart unexpectedly”), it 

would still be reported here. 

Modifications to Test Article(s) During Testing

 ̈ No modifications were made to the test articles during testing

 ̈ Modifications were made to the test articles during testing. Description of modification 

including their impact on prior test outcome(s) are provided below. 

Concerns Identified 

 ̈ No concerns were identified.

 ̈ Concerns were communicated to the device manufacturer; see list below.

List and description of concerns communicated to the device manufacturer. 

I confirm that:

 ̈ The above summary information includes all original and any retest data

 ̈ The above summary information is an accurate representation of the testing conducted

__________________________________________________________________________ Name: [TYPED NAME POSITION] Date

Description of modifications made to test articles during testing. Description of prior tests 

that were repeated based on modifications made or justification for not repeating prior 

tests. 
58

Summary

• For ASCA Accreditation applications: 

– Do 

• Review all relevant guidances, including the ASCA Pilot guidances 

• Submit complete applications 

– Don’t 

• Include standards outside the ASCA Pilot in your requested scope 

• Submit an accreditation body certificate that does not reflect ASCA standards

– Remember 

• Only test to standards in your ASCA scope of accreditation

• Note any exclusions defined in your scope of accreditation from your accreditation 

body
59

Summary

• Test plan development 

– Manufacturers are ultimately responsible 

– Test labs should use their expertise to help develop the test plan with manufacturers 

– Consider 

• The SIS for standards in the Pilot 

• Relevant FDA guidance

• Any partial recognitions and references provided on the SIS 

– If concerns identified by the test lab can’t be resolved, document that information in the 

Summary Test Report 

• Summary Test Reports 

– Example format in the ASCA guidance is not mandatory 

– Please ensure all example content is included
Questions?
61

Biocompatibility Resources

• 21 CFR 58 Good Laboratory Practices for Nonclinical Laboratory Studies 

regulations: 

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58

• General biocompatibility guidance: 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/useinternational-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-

evaluation-and

• FDA Biocompatibility Assessment Resource Center: 

https://www.fda.gov/medical-devices/premarket-submissions/biocompatibilityassessment-resource-center
62

• Standards & Conformity Assessment Program 

www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/standards-and-conformity-assessment-program#intro

• FDA Recognized Consensus Standards Database 

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

• CDRH Learn: How to Study and Market Your Device: Standards 

www.fda.gov/training/cdrhlearn/default.htm

Standards Resources
63

Standards Resources

• Recognition and Withdrawal of Voluntary Consensus Standards guidance 

www.fda.gov/regulatory-information/search-fda-guidance-documents/recognition-and-withdrawalvoluntary-consensus-standards

• Appropriate Use of Voluntary Consensus Standards in Premarket 

Submissions for Medical Devices guidance 

www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntaryconsensus-standards-premarket-submissions-medical-devices

• AAMI CR500:2019 Basic Introduction to the IEC 60601 Series report 
64

ASCA Resources

• ASCA Pilot web page 

www.fda.gov/medical-devices/standards-and-conformity-assessment-program/accreditation-schemeconformity-assessment-asca

• ASCA Pilot program guidance 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/accreditation-scheme-

•

conformity - assessment - asca - pilot - program 

ASCA Standards - specific guidances 

– Basic Safety and Essential Performance standards - specific guidance: 

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

– Biocompatibility standards - specific guidance: 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biocompatibility-testing-medicaldevices-standards-specific-information-accreditation-scheme

• Ask ASCA! ASCA@FDA.HHS.GOV
65

Additional Resources

Division of Industry and Consumer Education: 

DICE@fda.hhs.gov

Slide Presentation, Transcript and Webinar Recording will be 

available at: 

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

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

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