The ASCA Pilot: Streamlining Conformity 

Assessment in Device Submissions 

Simon Choi, Ph.D. 

CDRH Standards and Conformity Assessment Program 

Office of Strategic Partnerships and Technology Innovation 

Center for Devices and Radiological Health 

U.S. Food and Drug Administration
ASCA Goal:

Enhance the use of 

conformity 

assessment in 

premarket review

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This Photo by Unknown Author is licensed under CC BY-SA
Learning Objectives

• Describe the Accreditation Scheme for Conformity 

Assessment (ASCA) Pilot and its benefits 

• Describe premarket submission preparation with 

testing from ASCA - accredited test lab 

• Discuss Helpful Tips for participating in the ASCA Pilot

3
Introduction to ASCA Pilot

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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 ASCA?

• Enhances 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 

6
Terminology

• ASCA Recognition 

– Status granted by FDA to accreditation bodies 

– Demonstrate competence in accreditation activities 

• ASCA Accreditation 

– Status granted by FDA to testing laboratories 

– Demonstrate competence in testing through application process 

– Described in ASCA Pilot program guidance

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Pre-ASCA Pilot Stakeholders

FDA Industry

Testing 

Labs

Accreditation 

Bodies

ILAC: 

International 

Laboratory 

Accreditation 

Cooperation

8
ASCA Pilot Stakeholders

FDA Industry

ASCAaccredited

Testing Labs

ASCArecognized 

Accreditation 

Bodies

ILAC: 

International 

Laboratory 

Accreditation 

Cooperation

9
How ASCA Works

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

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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

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ASCA Pilot Standards: Biocompatibility

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

*** Please see the Biocompatibility standards - specific guidance for a full listing of standards and 

test methods and visit the Recognized Consensus Standards database for more information ***

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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)

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*** Please see the 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 ***
Preparing Premarket Submissions 

with Testing from 

ASCA-accredited Testing Laboratories

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Steps

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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 
• Check ASCA Pilot web page for ASCA standards 

• Consult Recognized Consensus Standards database 

− Supplementary Information Sheet (SIS) 

− Standard’s extent of recognition and edition

*** Manufacturers are responsible for selecting and using FDA - recognized 

consensus standards and test methods appropriately ***

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Identify ASCA Pilot Standards to be Cited

1
• Select an ASCA - accredited testing laboratory 

• Develop and agree on test plan 

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

– Considerations: 

• Relevant FDA guidance documents 

• FDA - recognized consensus standards 

• Testing outside a testing laboratory’s scope of ASCA Accreditation

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Develop and Agree on Test Plan with

ASCA-accredited Test Lab 2
• Submission elements 

– Cover letter with ASCA - specific information 

– Declaration of Conformity (DOC) 

– Summary Test Report(s) 

• Standards - specific guidances provide examples of 

DOCs and Summary Test Reports 

** Complete test reports are generally not needed for ASCA Pilot standards ** 

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3 Plan Submission Elements
• Testing laboratory 

– Conducts testing 

– Sends complete test reports and ASCA Summary 

Test Report(s) to manufacturer 

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Obtain Results and Summary Test 

Report(s) from Test Lab

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• Cover letter with ASCA-specific information

• Declaration of conformity 

• Summary Test Report(s) 

– Generally don’t need complete test reports 

– Manufacturer should not modify Summary Test Reports from 

testing laboratories 

• All other submission requirements

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Prepare FDA Submission 5
ASCA Pilot 

Premarket Submission Elements

** Device manufacturers are responsible for documenting how testing supports 

premarket authorization, even for ASCA Pilot submissions **

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 FDA - recognized consensus 

standard(s) and test 

methods used

ASCA Summary Test 

Report

Ø See standards - specific 

ASCA Pilot guidance 

documents for examples 

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ASCA Pilot Premarket Submission Elements

** Device manufacturers are responsible for documenting how testing supports 

premarket authorization, even for ASCA Pilot submissions **

Cover Letter 

Ø States that submission is 

for ASCA Pilot 

Ø Name, location and IDs of 

test lab(s) 

Ø 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 testing laboratory 

Ø See suggested content in 

guidance 

22
ASCA Pilot Premarket Submission Elements

** Device manufacturers are responsible for documenting how testing supports 

premarket authorization, even for ASCA Pilot submissions **

Cover Letter 

Ø States that submission is 

for ASCA Pilot 

Ø Name, location and IDs of 

test lab(s) 

Ø 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 testing laboratory 

Ø See suggested content in 

guidance 

23
ASCA Pilot Premarket Submission Elements

** Device manufacturers are responsible for documenting how testing supports 

premarket authorization, even for ASCA Pilot submissions **

Cover Letter 

Ø States that submission is 

for ASCA Pilot 

Ø Name, location and IDs of 

test lab(s) 

Ø 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 testing laboratory 

Ø See suggested content in 

guidance 

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Examples of ASCA DOCs

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Summary Test 

Report, page 1

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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

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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. 

Summary Test 

Report, page 3

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Helpful Tips

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Helpful Tips

1. Include appropriate references to ASCA in cover letter 

– Test lab information 

– ASCA standards and/or test methods 

2. Submit complete DOCs 

– for all cited FDA - recognized standards 

3. Include ASCA Summary Test Report(s) 

– as supplied by the testing laboratory 

4. Ask questions in advance 

– We’re here to help!

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Summary

The ASCA Pilot 

• Brings together conformity assessment bodies, FDA and medical 

device industry 

• Leverages international consensus standards 

• Advances regulatory science 

ASCA Goal: Enhance the use of conformity assessment 

in premarket review

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Summary

The ASCA Pilot 

• Increases consistency and predictability in assessing 

conformance with FDA - recognized standards 

• Reduces regulatory burden by streamlining conformity 

assessment 

• Ensures patient access to safe, effective devices 

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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 Summary Test Reports 

5. Prepare FDA submission 

• Three elements of an ASCA submission 

1. Cover letter with ASCA - specific information 

2. Declaration of Conformity 

3. Summary Test Reports

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ASCA Pilot Guidances

• ASCA Pilot program guidance: The Accreditation Scheme for Conformity Assessment 

(ASCA) Pilot Program - Final Guidance 

• Basic Safety and Essential Performance standards-specific guidance: 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 

• Biocompatibility standards - specific guidance: Biocompatibility Testing of Medical 

Devices- Standards Specific Information for the Accreditation Scheme for Conformity 

Assessment (ASCA) Pilot Program

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Website Resources

• ASCA Pilot Web page 

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

• Standards & Conformity Assessment Program 

www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standardsand-conformity-assessment-program#intro

• FDA Recognized Consensus Standards Database 

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

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• Recognition and Withdrawal of Voluntary Consensus Standards, final

guidance 

www.fda.gov/regulatory-information/search-fda-guidance-documents/recognition-andwithdrawal-voluntary-consensus-standards

• Appropriate Use of Voluntary Consensus Standards in Premarket 

Submissions for Medical Devices, final guidance 

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

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

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

Standards Resources

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Industry Education: 

Three Resources for You

1. CDRH Learn: Multi - Media Industry Education 

§ Over 200 modules 

§ Videos, audio recordings, power point presentations, software - based “how to” modules 

§ Mobile - friendly: access CDRH Learn on your portable devices 

www.fda.gov/CDRHLearn

2. Device Advice: Text - Based Education 

§ Comprehensive regulatory information on premarket and postmarket topics 

www.fda.gov/DeviceAdvice

3. Division of Industry and Consumer Education (DICE) 

§ Contact DICE if you have a question 

§ Email: DICE@fda.hhs.gov 

§ Phone: 1(800) 638 - 2041 or (301) 796 - 7100 (Hours: 9 am - 12:30 pm; 1 pm - 4:30pm EST) 

§ Web: www.fda.gov/DICE

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Your Call to Action

• Promote the use of recognized standards in device 

submissions 

• Participate in the ASCA Pilot 

• Email us at ASCA@FDA.HHS.GOV

• Participate in standards development!

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