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.   Contains Nonbinding Recommendations
Biocompatibility Testing of Medical 
Devices  Standards Specific 
Information for 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 at ASCA@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 VI 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 20012 and 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 20903, 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 
 
  Contains Nonbinding Recommendations 
Table of Contents 
 I.  Introduction ............................................................................................................................. 1 
II.  Scope ....................................................................................................................................... 2 
III.  List of FDA-Recognized Consensus Standards and Test Methods in the ASCA Pilot for 
Biocompatibility Testing of Medical Devices ................................................................................ 2 
IV.  Accreditation and Assessment of Testing Laboratories by ASCA-Recognized Accreditation 
Bodies ............................................................................................................................................. 4 
A.  Scope of Assessments ...................................................................................................... 4 
B.  ASCA Program Specifications for Biocompatibility Testing of Medical Devices .......... 4 
V.  Premarket  Submission  Contents  for  FDA-Recognized  Consensus  Standards  and  Test 
Methods in the ASCA Pilot for Biocompatibility Testing of Medical Devices ........................... 16 
A.  Cover Letter.................................................................................................................... 16 
B.  Declaration of Conformity ............................................................................................. 16 
C.  Supplemental Documentation ........................................................................................ 17 
VI.  Paperwork Reduction Act of 1995 ........................................................................................ 20 
Appendix A: Example ASCA Declaration of Conformity (DOC) for Biological Evaluation of 
Medical Devices Standards in the ASCA Pilot............................................................................. 21 
Appendix B: Example ASCA Summary Test Report for Biocompatibility Testing of Medical 
Devices: Irritation  Intracutaneous Reactivity (ISO 10993-10) .................................................. 24 
Appendix C: Example ASCA Summary Test Report for Biocompatibility Testing of Medical 
Devices: Cytotoxicity  MEM Elution (ISO 10993-5) ................................................................. 28 
Appendix D: Example ASCA Summary Test Report for Biocompatibility Testing of Medical 
Devices: Dermal Irritation (ISO 10993-10) .................................................................................. 31 
Appendix E: Example ASCA Summary Test Report for Biocompatibility Testing of Medical 
Devices: Guinea Pig Maximization Sensitization (ISO 10993-10) .............................................. 35 
Appendix F: Example ASCA Summary Test Report for Biocompatibility Testing of Medical 
Devices: Closed Patch Sensitization (ISO 10993-10) .................................................................. 40 
Appendix G: Example ASCA Summary Test Report for Biocompatibility Testing of Medical 
Devices: Acute Systemic Toxicity (ISO 10993-11) ..................................................................... 44 
Appendix H: Example ASCA Summary Test Report for Biocompatibility Testing of Medical 
Devices: Material-Mediated Pyrogenicity (ISO 10993-11 and USP 151).................................... 48 
Appendix I: Example ASCA Summary Test Report for Biocompatibility Testing of Medical 
Devices: Direct and Indirect Hemolysis (ISO 10993-4 and ASTM F756) ................................... 52 
Appendix J: Example ASCA Summary Test Report for Biocompatibility Testing of Medical 
Devices: Complement Activation (ISO 10993-4)......................................................................... 58 
 
  Contains Nonbinding Recommendations 
 
Biocompatibility Testing of Medical 
Devices  Standards Specific 
Information for 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 
This guidance provides information on how the Biological Evaluation of Medical Devices 
standards are incorporated into the Pilot Accreditation Scheme for Conformity Assessment 
Program (hereafter referred to as the ASCA Pilot). The ASCA Pilot is described in FDAs 
guidance The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.1 
 
For the edition of the FDA-recognized consensus standard(s) included in the ASCA Pilot, see 
the FDA Recognized Consensus Standards Database.2 For more information regarding use of 
consensus standards in regulatory submissions, please refer to the FDAs guidance 
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 
Devices3 and Standards Development and the Use of Standards in Regulatory Submissions 
Reviewed in the Center for Biologics Evaluation and Research.4   
                                                 
1 Available at: The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program 
2 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 
3 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices 
4 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/standards-
development-and-use-standards-regulatory-submissions-reviewed-center-biologics-evaluation 
        1  Contains Nonbinding Recommendations 
 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe 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.  Scope 
This guidance includes the following: 
 
  A list of the FDA-recognized consensus standards and test methods included in the 
ASCA Pilot for biocompatibility testing of medical devices; 
  The program specifications for the FDA-recognized consensus standards and test 
methods in the ASCA Pilot for biocompatibility testing of medical devices; and 
  The recommended premarket submission contents specific to FDA-recognized 
consensus standards and test methods for biocompatibility testing of medical devices 
when testing is conducted by an ASCA-accredited testing laboratory. 
 
FDAs guidance The Accreditation Scheme for Conformity Assessment (ASCA) Pilot 
Program describes how accreditation bodies, testing laboratories, device manufacturers, and 
FDA staff participate in the ASCA Pilot as well as how FDA-recognized consensus standards 
and test methods are selected and how program specifications are developed.  
 
Please see FDAs guidance Use of International Standard ISO 10993-1, Biological 
evaluation of medical devices - Part 1: Evaluation and testing within a risk management 
process5 for recommendations on biocompatibility testing to support a premarket 
submission. The ASCA Pilot for biocompatibility testing of medical devices does not include 
certain types of devices that require customized sample preparation and/or testing 
methodologies, or absorbable and in situ polymerizing devices, liquid devices, creams, gels, 
hydrogel devices, and devices containing nanomaterials.  
 
III.  List of FDA-Recognized Consensus Standards and 
Test Methods in the ASCA Pilot for Biocompatibility 
Testing of Medical Devices  
Biological evaluation assesses the biocompatibility-related risks of medical devices with 
direct and/or indirect contact with human tissue. When biocompatibility testing is needed as 
part of a premarket submission to FDA to address biocompatibility-related risks, the selected, 
cross-cutting biological evaluation standards listed below are relevant to many manufacturers 
and the device types are of significant public health importance.  
 
                                                 
5 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-
standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and  
        2  Contains Nonbinding Recommendations 
 
  ASTM F756: Standard Practice for Assessment of Hemolytic Properties of Materials 
  ASTM F720: Standard Practice for Testing Guinea Pigs for Contact Allergens: 
Guinea Pig Maximization Test 
  ISO 10993-4: Biological evaluation of medical devices  Part 4: Selection of tests for 
interactions with blood 
  ISO 10993-5: Biological evaluation of medical devices  Part 5: Tests for in vitro 
cytotoxicity 
  ISO 10993-10: Biological evaluation of medical devices  Part 10: Tests for irritation 
and skin sensitization 
  ISO 10993-11: Biological evaluation of medical devices  Part 11: Tests for systemic 
toxicity 
  USP <151>: Pyrogen Test 
  ISO 10993-12: Biological evaluation of medical devices  Part 12: Sample 
preparation and reference materials 
The eligible test methods included in the ASCA Pilot for biocompatibility testing of medical 
devices are: 
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 10993-106  Dermal Irritation, Intracutaneous Reactivity Irritation, and 
Closed Patch Sensitization 
ISO 10993-10 and ASTM F7207  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 
* See also ISO/TS 10993-20 for information on when complement activation should be considered for 
anaphylaxis (Table 2, Hypersensitivity Column). 
 
The extent of FDA recognition (complete or partial) is provided in the Supplemental 
Information Sheet (SIS) for each standard listed in the FDA Recognized Consensus 
Standards Database.8  The SIS provides additional information to consider when using FDA-
recognized consensus standards, such as relevant guidance documents that provide clarity on 
FDA recommendations for testing to support premarket submissions. 
 
                                                 
6 We support the principles of the 3Rs, to reduce, refine, and replace animal use in testing when feasible. We 
encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable, 
adequate, validated, and feasible. We will consider if such an alternative method could be assessed for 
equivalency to an animal test method. See generally: https://www.fda.gov/science-research/advancing-
regulatory-science/vi-modernizing-safety-testing  
7 Ibid 
8 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm  
        3  Contains Nonbinding Recommendations 
 
IV.  Accreditation and Assessment of Testing Laboratories 
by ASCA-Recognized Accreditation Bodies 
A.  Scope of Assessments 
Section 7 of ISO/IEC 17011: Conformity assessment  Requirements for accreditation bodies 
accrediting conformity assessment bodies (hereafter referred to as ISO/IEC 17011) 
describes processes by which accreditation bodies assess testing laboratories. In order to 
maintain conformance to ISO/IEC 17011, an accreditation body assesses a sample of the 
scope of accreditation of its accredited testing laboratories at least every two years.9 When 
assessing a testing laboratory under the ASCA Pilot, an accreditation body is expected to 
assess all (and not a sample of) biological evaluation standards and test methods. That is, in 
the ASCA Pilot, ASCA-recognized accreditation bodies are expected to assess all (and not a 
sample) of the biological evaluation of medical devices standards and test methods in order 
to ensure competence across the testing laboratorys scope of ASCA Accreditation.  
B.  ASCA Program Specifications for Biocompatibility 
Testing of Medical Devices 
The ASCA program specifications in this section provide expectations for the accreditation 
of testing laboratories for the biocompatibility testing of medical devices under the ASCA 
Pilot.  ASCA-recognized accreditation bodies, following the processes of ISO/IEC 17011, 
accredit testing laboratories to all relevant elements of ISO/IEC 17025: 2017: General 
requirements for the competence of testing and calibration laboratories (hereafter referred to 
as ISO/IEC 17025) as well as the ASCA program specifications identified in this section. 
In addition, all testing should be conducted considering the recommendations in the CDRH 
Biocompatibility policy as described in FDAs guidance Use of International Standard ISO 
10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a 
risk management process. For readability and ease of reference, the numbering and 
nomenclature (including the term requirements)10  below correspond to the numbering and 
nomenclature of clauses/subclauses in ISO/IEC 17025.   
 
ISO/IEC 17025 Section 4 General requirements 
4.1 Impartiality 
If any services, such as consulting, design, or research, are offered by the testing laboratory, 
it agrees to have a policy and procedure for maintaining impartiality through separation of 
those services from its testing activities. 
A device manufacturers internal testing laboratory agrees to have policies and procedures 
that specifically ensure and protect the impartiality of the laboratory to test or otherwise 
                                                 
9 See 7.9.3 of ISO/IEC 17011: 2017: Conformity assessment  Requirements for accreditation bodies 
accrediting conformity assessment bodies. 
10 Some definitions within voluntary consensus standards refer to requirements. FDAs references to them for 
the ASCA Pilot do not make them legal or regulatory requirements unless specifically identified as such. 
        4  Contains Nonbinding Recommendations 
 
evaluate devices manufactured by the laboratorys parent organization and, if applicable, 
other manufacturers without regard to the impact of the test results on the parent 
organizations business interests. 
4.2 Confidentiality 
There are no additional specifications above those set forth in ISO/IEC 17025. 
ISO/IEC 17025 Section 5 Structural requirements 
There are no additional specifications above those set forth in ISO/IEC 17025. 
ISO/IEC 17025 Section 6 Resource requirements 
6.1 General 
There are no additional specifications above those set forth in ISO/IEC 17025. 
6.2 Personnel 
a)  The testing laboratory agrees to maintain competent technical personnel that are 
knowledgeable in appropriate test method for the requested scope of accreditation:  
  For technicians performing in vivo tests, 1 year of relevant test experience 
with each standard test included in the ASCA program to which technicians 
are assigned OR demonstrated proficiency through completion minimally of 
25 tests OR 25 phases as outlined in each study specific training and:   
-  Bachelors or associate degree in relevant science areas to the in vitro/in 
vivo biocompatibility testing included in the ASCA Pilot, OR  
-  a high school degree, and at least one of the following laboratory 
technician accreditations: Laboratory Animal Technician (LAT), Assistant 
Laboratory Animal Technician (ALAT), and/or Laboratory Animal 
Technologist (LATG). 
  For technicians performing in vitro tests 1 year of relevant test experience 
with each standard test included in the ASCA program to which technicians 
are assigned, OR demonstrated proficiency through completion minimally of 
25 tests, OR 25 phases as outlined in each study specific training  and: 
-  Bachelors or associate degree in relevant science areas to the in vitro/in 
vivo biocompatibility testing included in the ASCA Pilot. 
  For technicians performing any test specific (e.g., for complement activation) 
sample preparation, 1 year of sample preparation experience with the relevant 
standard test included in the ASCA program to which technicians are 
assigned, OR demonstrated proficiency through completion of sample 
preparation for minimally 25 tests as outlined in each study specific training  
and: 
-  Bachelors or associate degree in science. 
  For technicians performing sample preparation that is applicable for various 
tests (e.g., technicians in general sample preparation lab who prepare 
samples/extracts for various tests), 1 year sample preparation experience with 
any standard test included in the ASCA program OR demonstrated 
        5  Contains Nonbinding Recommendations 
 
proficiency through completion of sample preparation for minimally 25 of any 
of the standard tests in the ASCA program and: 
-  Bachelors or associate degree in science. 
  For study directors: 
-  Bachelors or higher degree in scientific discipline; AND 
-  2 years of relevant test experience with each standard test; AND 
-  Direction of at least 25 studies in each relevant test, OR management of  
25 studies with someone who has directed at least 25 studies in each 
relevant test. 
b)  The testing laboratorys management agrees to be knowledgeable in applicable 
aspects of the FD&C Act and 21 CFR regulations pertinent to the oversight of 
medical devices and the criteria set out in ISO/IEC 17025 and ASCA program 
specifications. The testing laboratory further agrees to maintain a list of laboratory 
managers and contact information. 
c)  The testing laboratory agrees to:  
  Document and maintain a training program for new and previously trained 
technical personnel, which will include the proper procedures for applying 
new/updated test procedures and performing required tests.  
  Provide new and previously trained  technical personnel relevant test-specific 
requalification training (e.g., cytotoxicity subjective scoring) every 6-12 
months, or when test standards or procedures are updated or developed, as 
well as when responsibilities have changed.  
  Conduct training on a periodic basis through application of training 
approaches, such as on-the-job training and formal classroom training, as 
appropriate.  
  Document and maintain records of training demonstrating that technical 
personnel who participate in the conduct of ASCA testing have been trained 
and evaluated to be competent in the performance of each ASCA test. The 
training includes the ability to follow test-related standard operating 
procedures (SOPs) and documentation, and in person hands-on training. 
Training may also include classroom (or online) training. Testing laboratories 
further agree to have predefined criteria to qualify that technical personnel 
(technicians and study directors) can perform assigned tasks related to the 
tests under the scope of ASCA Accreditation, and for when retraining will be 
needed.  
  Establish procedures for periodic internal test lab proficiency checks of 
technicians (e.g., blind scoring of negative and positive controls for MEM 
elution assays) for the tests performed under the ASCA Pilot with subjective 
analyses, to include when staff would require retraining (e.g., protocol non-
conformance, change in assigned activities).  
  Maintain records demonstrating trainers have qualifications and at least 2 
years experience (routinely performing each relevant ASCA test) to train the 
technical personnel who will perform the ASCA tests. 
        6  Contains Nonbinding Recommendations 
 
d)  The testing laboratory agrees to have procedures to establish how test and control 
samples are prepared and training that includes at a minimum the following: 
  Procedures for device preparation, including: 
-  Cutting samples (if appropriate) and documentation (e.g., photographs) of 
any particle generation prior to extraction, 
-  Determination of device surface area for extraction ratio, and the volume 
required to complete the study,  
-  Use of non-standard surface area approaches (e.g., porous devices), 
-  Exclusion of non-contacting components from extraction, 
-  Selection of representative portions for direct contact hemocompatibility 
studies (i.e., hemolysis, complement activation), 
  Selection of extraction conditions (i.e., time, temperature, and extraction 
vehicle), 
  Assessment and documentation of changes (e.g., photographs) after extraction 
to sample (e.g., color changes, integrity, swelling) or extract conditions (e.g., 
pH, particles/precipitates, color changes, or turbidity), 
  General and/or test-specific follow-up procedures when changes are noted 
(e.g., extract settling techniques to allow particle-free IV injections), 
  Use of non-standard extraction approaches (e.g., fluid path approaches, 
approaches for extremely large devices, procedures to maintain contact with 
extraction vehicle), and 
  Handling of extracts prior to testing (e.g., filtration, centrifugation, storage 
time and temperature). 
e)  In addition, for in vitro testing, the testing laboratory agrees that training will include 
the following, at a minimum: 
  MEM elution cytotoxicity:  
-  Cell line maintenance 
-  Cell counting 
-  Cell seeding 
-  Addition of test and control samples to the cell cultures 
-  Scoring of test and control articles 
-  Mock study to assess technician competence in test performance, data 
documentation, and result interpretation (including test-specific 
assessment of borderline results) 
-  Minimally, biannual periodic technician proficiency check of negative and 
positive control scoring, and additional technician retraining, if needed 
  Hemolysis: 
-  Timing from blood collection to use in test 
-  Hemoglobin absorbance standard curve 
-  Dilution procedures and dilution factor calculations 
-  Sample and control preparation and documentation  
-  Representative sample selection(may apply to both direct and indirect 
contact tests)  
        7  Contains Nonbinding Recommendations 
 
-  Documentation of supernatant color and presence of dispersed pellet 
fragments, if any 
-  Documentation of presence or absence of pellet, pellet size, and color after 
centrifugation if different than negative control 
-  Supernatant removal to preserve pellet 
-  Blank sample correction (including if an extract is colored) 
-  Hemolytic index calculation 
-  Mock study to assess technician competence in test performance, data 
documentation, and result interpretation 
-  Technician retraining, if needed 
  Complement activation: 
-  Serum/blood/plasma handling to minimize complement activation 
-  Sample and control preparation and documentation 
-  Representative sample selection 
-  Small volume pipetting 
-  Complement absorbance standard curve 
-  Dilution procedures and dilution factor calculations 
-  Exposure time 
-  Complement concentration calculations 
-  Test validation criteria 
-  Data analysis and use of historical control data, if necessary 
-  Mock study to assess technician competence in test performance, and data 
documentation, and result interpretation 
-  Technician retraining, if needed  
f)  For in vivo studies, as part of the general animal handling training, the testing 
laboratory agrees that training will include the following, at a minimum: 
  Test-specific animal selection criteria 
  Animal identification and traceability within and across studies (e.g., for 
pyrogenicity) 
  Species- and test-specific animal holding techniques  
  Test-specific acclimation techniques 
  Body weight measurement 
  Species-specific in life observations (e.g., cage accidents, decline in health, 
seizures, weight loss, breathing difficulties) and when veterinarian oversight 
should be requested 
  Test-specific data documentation, calculations, and result interpretation 
(including test-specific assessment of borderline results, and re-challenge or 
re-test criteria, when applicable) 
  Technician retraining, if needed 
g)  For the following specific in vivo tests, the application organization agrees that 
training will include the following, at a minimum: 
  Guinea Pig Maximization (GPMT) and Closed Patch Sensitization: 
-  Shaving techniques (e.g., to avoid razor burn) 
        8  Contains Nonbinding Recommendations 
 
-  Mixing of extract and adjuvant, if applicable  
-  Intradermal injection (GPMT) including criteria to confirm avoidance of 
subcutaneous injections 
-  Sample application (GPMT and Closed Patch) 
-  Animal wrapping 
-  Differentiation for source of redness (e.g., true sensitization versus 
mechanical/adhesive irritation) 
-  Minimally, quarterly periodic technician proficiency check of positive 
control scoring (in live animals at least once annually) 
-  Technician retraining, if needed 
  Intracutaneous Reactivity and Dermal Irritation: 
-  Shaving techniques (e.g., to avoid razor burn) 
-  Application of test samples 
-  Injection technique and signs to confirm appropriate injection location 
-  Differentiation for source of redness (e.g., true irritation versus possible 
irritation from shaving) 
-  Minimally, biannual periodic technician proficiency check of positive 
response scoring (in live animals at least once annually) 
-  Technician retraining, if needed 
  Acute Systemic Toxicity: 
-  Balance use and calibration to ensure appropriate sensitivity 
-  Intraperitoneal (IP) and intravenous (IV) injection techniques and signs to 
confirm appropriate injection location 
-  Minimally, technician proficiency check on injection techniques prior to 
conduct of next test if it has been more than one month between 
technician conduct of a study 
-  Technician retraining, if needed 
  Material-mediated pyrogenicity: 
-  Use of pyrogen-free/depyrogenated glassware and pyrogen free saline for 
extraction 
-  Temperature probe use and calibration to ensure appropriate sensitivity 
-  Intravenous (IV) injection techniques and signs to confirm appropriate 
injection location 
-  Technician retraining if needed. 
6.3 Facilities and environmental conditions 
Lab personnel should be aware of the FD&C Act and regulations as applicable to medical 
device manufacturers. Under 21 CFR 820.50, Purchasing Controls, medical device 
manufacturers must communicate as part of contracted work any environmental conditions 
necessary for the proper conduct of testing done under the scope of accreditation.  In 
addition, testing laboratories should have policies and procedures in place to implement 21 
CFR part 58, Good Laboratory Practices, for Nonclinical Laboratory Studies. 
6.4 Equipment 
        9  Contains Nonbinding Recommendations 
 
a)  The testing laboratory agrees to ensure that all equipment used for testing and 
evaluating devices is available and in proper working order for the requested scope of 
accreditation. 
b)  The testing laboratory agrees to ensure that its procedures address adding, deleting, 
modifying, or maintaining information in equipment records in an accurate and timely 
manner, and specify the personnel responsible for these tasks.  
c)  The testing laboratory agrees to ensure that its procedures specify the steps for 
establishing calibration intervals for each type or item of equipment, and specify 
criteria, steps, and approvals for extending the calibration interval of an instrument. 
d)  The testing laboratory agrees to have procedures to examine the effects of equipment 
operation outside the equipment tolerances or study specified limits (e.g., temperature 
excursions) on test results. The procedures identify the personnel responsible for such 
examination of the equipment (e.g., technicians) and determination of acceptability 
with respect to test validity (e.g., study directors/toxicologists), specify their 
responsibilities, and provide the steps for determining if the equipment variation 
would impact the study results, including:  
  Determining whether the effects are unacceptable (including the accept/reject 
criteria);  
  Identifying the conducted tests affected;  
  Analyzing the results impacted for these particular tests; and  
  Determining whether retesting is required. 
6.5 Metrological traceability 
a)  Testing laboratories agree to use specified methods and/or standards that clearly 
describe the following: 
  Calibration to three decimal places for spectrophotometer absorbance readings 
for hemolysis and complement activation, and  
  Particle ranges for calibration of coulter counter use for cell counting.  
b)  If test-specified positive, negative, and/or reference controls are no longer able to 
distinguish between positive and negative responses, the testing laboratory agrees to 
have procedures to qualify new controls. 
c)  The testing laboratory agrees that controls (positive/negative/reagent, if applicable) 
will meet assay-specific acceptance criteria. 
d)  The testing laboratory agrees that, when concurrent positive controls are not 
conducted with the test article (i.e., sensitization testing), biannual testing (i.e., within 
3 months of the test article) will be conducted to confirm the ability of the test system 
to detect a positive sensitization response. If it is determined that the periodic positive 
control is no longer valid, all testing conducted after the last validated positive control 
run cannot be submitted as part of the ASCA Pilot. 
       10  Contains Nonbinding Recommendations 
 
6.6 Externally provided products and services 
a)  The testing laboratory agrees to ensure that any subcontractors utilized to conduct 
testing under the scope of ASCA Accreditation are ASCA-accredited testing 
laboratories for the selected tests.   
ISO/IEC 17025 Section 7 (Process requirements) 
7.1 Review of requests, tenders and contracts 
There are no additional specifications to those set forth in ISO/IEC 17025. 
7.2 Selection, verification and validation of methods 
a)  The testing laboratory agrees that its management system will include procedures 
governing the development, maintenance, and use of test procedures (including 
associated documents such as test data forms and checklists). These management 
system procedures include steps for:  
  Identifying the personnel responsible for developing, reviewing, and 
maintaining these documents  
  Specifying the frequency of review by technical personnel and management  
  Ensuring consistency with applicable standard(s)  
  Ensuring test modifications are reviewed by personnel who are competent to 
the applicable standard(s) 
  Identifying and documenting the types of modifications to the test procedures that 
do not need to be reviewed by FDA for confirmation prior to implementation, if 
included in the test lab application. The testing laboratory further agrees that 
changes (either at the request of study sponsor or initiated by the test lab) to any 
procedures regarding the following as well as any unanticipated changes will be 
confirmed with FDA and its Accreditation Body prior to implementation: 
-  Changes to sample for retesting to achieve a passing result 
-  pH adjustments 
-  Sample filtration or other extract manipulation 
-  Removal or modification of documentation associated with color, turbidity 
or particles in the test extract, or swelling/degradation of the test article 
-  Frequency of non-concurrent control testing 
-  Changes to acceptance criteria outside the validated/qualified laboratory-
specific limits (e.g., for complement activation where the standard 
methods do not specify acceptable limits) 
-  Changes to data calculations and presentation, if applicable (e.g., 
hemolytic index, irritation index, complement activation plots) 
-  Changes in the criteria for re-challenge or retesting 
-  Changes in the criteria for reportable adverse clinical observations or 
animal deaths 
b)  The testing laboratory agrees that test procedures will include or specify, as 
appropriate, the following:  
       11  Contains Nonbinding Recommendations 
 
  Unique identification, including title, document number, revision, and 
effective date;  
  Specific test equipment to use along with their required ratings;  
  Warnings/caution statements to alert the operators of potential hazards;  
  Normal and any unusual ambient conditions (including tolerances) for tests;  
  Test data to be obtained and recorded;  
  Objective acceptance criteria for results including the essential performance 
required to be maintained;  
  Testing techniques (i.e. test methods) required to ensure consistent results; 
  Instructions on test conduct, including equipment operation, reagent 
preparation, cell line and animal handling, techniques, preparation of test 
samples (including instructions for sample traceability during testing, if 
applicable), conduct of each step of the test, data recording, and scoring 
assessment procedures; 
  Deviations from the SOP, as well as any equipment deviations and discussion 
of why deviations will not impact the validity of the study results. 
c)  The testing laboratory agrees to ensure that relevant contextual information from the 
intended use of the device are reflected in the test procedure to ensure that the types 
of biological evaluation assessments recommended by FDA are considered based on 
tissue type and duration of contact with the device.  In addition, relevant information 
from the manufacturers essential performance specifications, including any 
metrological stability, are also reflected in each test procedure to ensure that the test 
procedures (e.g., extraction temperature and time) are compatible with the device. 
d)  The testing laboratory agrees to ensure that each test procedure adequately addresses 
all the applicable specifications of the standard for the devices being tested.  
7.3 Sampling 
a)  The testing laboratory agrees that the procedure(s) for sample preparation will meet 
the specifications of ISO 10993-12 and FDAs guidance Use of International 
Standard ISO 10993-1, "Biological evaluation of medical devices--Part 1: Evaluation 
and testing within a risk management process" and include the following: 
  Use of surface area/extraction volume ratio (unless mass/extract volume ratio 
results in equivalent or higher amount of test sample) 
  No dilutions of extract or test solutions, unless required for dose-dependent 
cytotoxicity studies 
  No filtration/centrifugation 
  No pH/osmolality adjustment 
  Documentation of any color changes, turbidity or particles in the extract 
  How representative portions are selected for testing, if the test system cannot 
accommodate all of the direct and indirect tissue contacting device 
components, to include documentation of what was excluded  
  How extraction vehicle volume will be determined and documented for 
absorbent devices (e.g., spongy devices) 
       12  Contains Nonbinding Recommendations 
 
  How sample extraction ratios will be selected for devices having multiple 
components with different thicknesses 
  How components with different types and durations of contact will be 
separated for sample preparation and testing 
  Situations when pooled component samples (with same or different types or 
duration of tissue contact) will be allowed  
  Inclusion of only tissue contacting components (unless procedure describes 
how inclusion of non-tissue contacting components will be addressed in 
determination of extraction ratios) 
  Submersion of large devices completely in extraction vehicle 
  How extractions will be conducted for devices containing fluid path 
components 
  That the following types of devices are excluded for the ASCA Pilot: 
absorbable and in situ polymerizing devices, liquid devices, creams, gels, 
hydrogel devices, and devices containing nanomaterials. 
7.4 Handling of test or calibration items 
There are no additional specifications to those set forth in ISO/IEC 17025. 
7.5 Technical records 
There are no additional specifications to those set forth in ISO/IEC 17025. 
7.6 Evaluation of measurement uncertainty 
There are no additional specifications to those set forth in ISO/IEC 17025. 
7.7 Ensuring the validity of results 
To confirm the validity of the testing methods, any test-specified positive, negative, and/or 
reference controls allow for distinguishing between positive and negative responses. The 
testing laboratory agrees that pre-defined criteria for positive/negative/reference control 
values will be as follows: 
  For cytotoxicity testing (per ISO 10993-5): 
-  each positive control material replicate is  Grade 3 
-  each negative control material replicate is Grade 0 
-  each vehicle control replicate is Grade 0 
  For intracutaneous reactivity irritation testing: 
-  each of five  sodium chloride control sites in each animal at all timepoints 
is Grade 0 
-  each of five oil control sites in each animal at all timepoints is  Grade 1 
  For primary skin (dermal) irritation testing, each sodium chloride and oil 
control site is Grade 0 
  For guinea pig maximization sensitization testing (per ASTM F720):11 
                                                 
11 ASTM F720-17: Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization 
Test 
       13  Contains Nonbinding Recommendations 
 
-  all sodium chloride and oil vehicle control animals have Grade 0 results at 
all sites  
-  the positive controls are run at least biannually (for each animal source) 
and each animal is at least one grade higher than concurrently run sodium 
chloride and oil vehicle controls in at least 8 out of 10 positive control 
animals (for strong sensitizers such as 0.1-0.5% dinitrochlorobenzene 
(DNCB) at induction and 0.05-0.1% DNCB at challenge)  
  For closed patch sensitization testing: 
-  all negative control animals (e.g., sodium chloride or oil vehicles or 
negative control materials) are Grade 0. 
-  the positive controls are run at least biannually (for each animal source) 
and each animal is at least one Grade higher than concurrently run sodium 
chloride and oil vehicle controls in at least 8 out of 10 positive control 
animals (for strong sensitizers such as 0.1-0.5% DNCB at induction and 
0.05-0.1% DNCB at challenge)  
  For acute systemic toxicity testing, all sodium chloride and oil control 
animals result in no adverse clinical findings, no decrease in body weight > 
10% per animal, and no deaths  
  For material-mediated pyrogenicity testing there are no predefined criteria 
  For hemolysis testing (per ASTM F756): 
-  the positive control material mean hemolytic index is  5%  
-  the negative control material mean hemolytic index is < 2%  
  For complement activation testing using SC5b-9 (a product of the terminal 
pathway for complement activation),  
-  the positive control meets one of the following criteria: 
  the mean value for the cobra venom factor positive control (if 
o
applicable) is at least 10X greater than both the mean values for the 
negative control material and the activated normal human serum, 
plasma, or whole blood, or 
  the positive material control (if applicable) is statistically significantly 
o
higher than both the negative control material and the activated 
normal human serum, plasma, or whole blood, 
-  any kit-specific high and low controls meet the kit specifications. 
7.8  Reporting of results 
a)  The testing laboratory agrees that it will have procedures to record all required 
information in ISO/IEC 17025 for each test conducted, including the following: 
  Test procedure(s) and test standard(s) used  
  Product or component(s) tested 
  Test equipment used for testing, measurement, or review (including the 
equipments ratings and accuracies, unless otherwise readily available)  
  Date of the test(s). For example, periodic controls may have different test 
dates  
  Test report number, including revision number and amendment date, if 
applicable, and any related sub-contracted test report number(s)  
       14  Contains Nonbinding Recommendations 
 
  Names of the personnel performing the test(s) and the names of all 
supervisory personnel involved in the study and for biological studies, the 
signature of the study director and quality assurance unit personnel (i.e., per 
21 CFR part 58, Good Laboratory Practices for Nonclinical Laboratory 
Studies, requirements)  
  The test conditions as specified by the test standard, if applicable, (e.g., 
required voltage, power, temperature, or humidity for the test) 
  Sample preparation: 
-  images of device (or representative portion, if full device is not used) prior 
to and post sample preparation 
-  use of subdivision/cutting 
  Extraction conditions, if applicable: 
-  extraction vehicle, time, temperature, and test article/vehicle ratio  
-  storage time and temperature prior to application to the test system  
-  images of vehicle post-extraction (color, cloudiness, presence of 
particulates) 
  Sample manipulation: 
-  filtration, centrifugation, dilution, pH adjustment, osmolality adjustment 
or other deviations from the sampling procedures 
  Any deviations from the laboratorys ASCA accepted procedures as well as 
any amendments to the test report  
  Test results to include: 
-  opinions and interpretations included in a test report  
-  all of the applicable data required by the laboratory's procedures; and 
-  a statement that testing was conducted according to 21 CFR 58 Good 
Laboratory Practices for Nonclinical Laboratory Studies regulations12  
b)  The testing laboratory agrees that testing conducted by subcontractors will also 
comply with the above test report specifications, as applicable.   
c)  The testing laboratory agrees that the complete test report and an ASCA Summary 
Test Report will be submitted to the client at the end of testing activities  
7.9 Complaints 
There are no additional specifications than those set forth in ISO/IEC 17025. 
7.10 Nonconforming work 
There are no additional specifications than those set forth in ISO/IEC 17025. 
7.11 Control of data and information management 
There are no additional specifications than those set forth in ISO/IEC 17025. 
ISO/IEC 17025 Section 8 (Management system requirements) 
                                                 
12 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. 
       15  Contains Nonbinding Recommendations 
 
8.1 Options  
 
Regardless of the option selected (i.e., Option A or Option B), the testing laboratory agrees to 
maintain an 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 biological evaluation of medical device standards or test 
methods. 
 
V.  Premarket Submission Contents for FDA-Recognized 
Consensus Standards and Test Methods in the ASCA Pilot 
for Biocompatibility Testing of Medical Devices 
FDA recommends that the following be included in any regulatory submission that contains 
biocompatibility testing conducted by an ASCA-accredited testing laboratory.  
A.  Cover Letter 
FDAs recommendations regarding the content to be included in a cover letter for a 
premarket submission containing testing results from an ASCA-accredited testing laboratory 
are provided in FDAs guidance The Accreditation Scheme for Conformity Assessment 
(ASCA) Pilot Program.   
B.  Declaration of Conformity 
Section IV.A. of FDAs guidance Appropriate Use of Voluntary Consensus Standards in 
Premarket Submissions for Medical Devices13 recommends contents for a declaration of 
conformity (DOC) to an FDA-recognized consensus standard.  For biocompatibility testing 
from an ASCA-accredited testing laboratory, FDA recommends the device manufacturer 
include the following additional items in the DOC:  
  Date(s) the testing was conducted 
  Location(s) where the testing was conducted 
  Confirmation that the FDA-recognized consensus standards (and specific test 
methods) used during testing were within the laboratorys scope of ASCA 
Accreditation and not subject to any temporary labeling constraints as a result of a 
suspension of ASCA Accreditation at the time testing was conducted. If the relevant 
standard (and specific test method) was impacted by a suspension of ASCA 
Accreditation, the DOC should include an explanation of how this suspension may or 
may not affect the testing results.   
  Limitations on the validity of the DOC: 
                                                 
13 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices  
       16  Contains Nonbinding Recommendations 
 
  How the test article compares with the device provided in this premarket 
submission (including selection of representative devices/portions)14  
  How any concerns communicated by the test lab were resolved  
  How any observations and/or degradations during testing were resolved 
  Whether any adverse or unusual findings as described in the list in Section V.C.  
occurred and, if so, rationale for acceptability 
An example DOC is provided in Appendix A of this guidance. This example provides one 
approach to how a single DOC might contain testing to FDA-recognized consensus standards 
included and not included in a testing laboratorys scope of ASCA Accreditation.  
C.  Supplemental Documentation 
An ASCA summary test report is recommended for all testing conducted under the ASCA 
Pilot. Example ASCA summary test reports are provided in Appendices B- J of this 
guidance. Note that the ASCA-accredited testing laboratory provides the ASCA summary 
test report to the device manufacturer who then includes it with its own DOC in a premarket 
submission to FDA. Depending on the information provided in the DOC or the ASCA 
summary test report, FDA may or may not need to review the complete test report for 
biocompatibility testing,15 and the testing laboratory and/or device manufacturer may also be 
requested to provide a rationale to support a decision on a premarket submission. 
 
During the ASCA Pilot, FDA generally will accept determinations from ASCA-accredited 
testing laboratories (i.e., test results) when the standard and test methods are within the 
testing laboratorys scope of ASCA Accreditation at the time of testing. Circumstances where 
FDA may request and review additional information related to testing from an ASCA-
accredited testing laboratory are described in the bulleted points of Section XIII. A of the 
guidance titled The Accreditation Scheme for Conformity Assessment (ASCA) Pilot 
Program.  
 
The ASCA Pilot processes and policies enhance confidence in testing results only when 
specific test methods and acceptance criteria are used. For example, FDA reviews 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) for testing laboratories that apply for a scope of ASCA Accreditation that 
includes biocompatibility testing. This review provides FDA an understanding of how testing 
is conducted, thereby providing confidence in the competence of ASCA-accredited testing 
laboratories. Depending on the specific device or intended use, deviations or amendments 
relative to the testing documentation submitted to FDA during the ASCA Accreditation 
                                                 
14 Please see FDAs guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical 
devices - Part 1: Evaluation and testing within a risk management process" for considerations regarding the use 
of medical devices in their final finished form or a representative test article for biocompatibility testing. 
15 A complete test report for biocompatibility testing is described in Attachment E of FDAs guidance Use of 
International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing 
within a risk management process 
       17  Contains Nonbinding Recommendations 
 
application process16 may be appropriate. In such cases, FDA recommends a complete test 
report be included in the premarket submission.  FDA also recommends a complete test 
report be included in the premarket submission for specific circumstances when (based on 
FDAs review experience) results may indicate a potential concern; these cases are noted 
below and in each example ASCA summary test report (Refer to Appendices B-J). 
 
To allow FDA to determine if any additional information is needed, and whether the ASCA 
summary test report was insufficient for evaluation, a complete test report (in addition to the 
ASCA summary test report) is recommended for biocompatibility testing of medical devices 
in the cases outlined below.  
  If test article was prepared per the ASCA Test Article Prep SOP specified on the 
ASCA summary test report (Refer to Appendices B-J of this guidance) with 
deviations/amendments (e.g., filtering, extract manipulation, pH adjustment) 
  If extraction solvent, ratio, or conditions other than those specially called out in the 
example ASCA summary test report (Refer to Appendices B-J of this guidance) were 
used  
  If there were any changes in color/turbidity or particles in the test article and/or 
extract OR there was swelling/degradation of the test article 
  If testing was conducted per the  ASCA Test Method SOP specified on the ASCA 
summary test report (Refer to Appendices B-J of this guidance) and per 21 CFR 58 
with deviations/amendments.  
  For irritation- intracutaneous reactivity (ISO 10993-10) testing: 
  If the overall score differences between the test and control are greater than 
one (i.e., per ISO 10993-10:2010, Clause 6.4.7), or if there were non-zero 
results for any of the sodium chloride control sites in any animal or results 
greater than 1 for any of the oil control sites in any animal at any timepoint.  
  If adverse clinical findings or animal deaths occurred.  
  For cytotoxicity  MEM Elution (ISO 10993-5) testing: if there were non-zero results 
for the test article, vehicle control or negative control, or if there were results less 
than 3 for the positive control at any timepoint. 
  For dermal irritation (ISO 10993-10):  
  If direct contact was used and the test article was not the entire final finished 
device or a representative sample selection per the ASCA Test Article Prep 
SOP 
  If the primary irritation score is calculated using different timepoints besides 
24hrs, 48hrs and 72hrs, if there were any non-zero test or control (e.g., direct 
contact control: gauze; extract test control: sodium chloride or oil) results at 
any time point. 
  If adverse clinical findings or animal deaths occurred.  
  For guinea pig maximization sensitization (ISO 10993-10 and ASTM F720): 
                                                 
16 Testing that includes deviations (and for which a DOC would not be appropriate) does not meet the criteria 
for inclusion in the ASCA Pilot as described in Section XII.B. of the guidance titled The Accreditation Scheme 
for Conformity Assessment (ASCA) Pilot Program. 
       18  Contains Nonbinding Recommendations 
 
  If the Magnusson and Kligman grades of 1 or greater observed in the test 
group, provided grades of less than 1 are seen in corresponding sodium 
chloride or oil control animals (i.e., per ISO 10993-10:2010, Clause 7.5.6).   
  If differences in source, strain, treatment methods, or timing of the positive 
control occurred 
  If adverse clinical findings or animal deaths occurred.  
  For closed patch sensitization (ISO 10993-10): 
  If direct contact was used and the test article was not the entire final finished 
device or a representative sample selection per the ASCA Test Article Prep 
SOP 
  If the Magnusson and Kligman grades of 1 or greater observed in the test 
group, provided grades of less than 1 are seen in negative control animals (i.e., 
per ISO 10993-10:2010, Clause 7.5.6), or the sodium chloride and oil vehicle 
controls are > Grade 0 
  If differences in source, strain, treatment methods, or timing of the positive 
control occurred 
  If adverse clinical findings or animal deaths occurred.  
  For acute systemic toxicity (ISO 10993-11): 
  If any test or control animals died or had any adverse clinical findings 
  If any test animals had a body weight loss greater than 10%.  
  For material-mediated pyrogenicity (ISO 10993-11 and USP 151): 
  If any rabbit has a baseline temperature exceeding 39.8C, or if any rabbit has 
a temperature rise 0.5C 
  If adverse clinical findings or animal deaths occurred.  
  For direct and indirect hemolysis (ISO 10993-4 and ASTM F756): 
  If direct contact was used and the test article was not the entire final finished 
device or a representative sample selection per the ASCA Test Article Prep 
SOP 
  If direct contact was used and a diluent other than Magnesium and Calcium 
Free PBS was used (i.e., per ASTM F756-17, Section 3.1.10) 
  If direct contact was used and an exposure ratio other than those specially 
called out in the example ASCA summary test report (Refer to Appendix I of 
this guidance) was used (i.e., per ASTM F756-17, Section 9.2.1)  
  If negative and positive controls did not perform as expected, the negative 
control, test article, and blank had absorbance values of 0.000 for all 
replicates, or test article scores of 2% Hemolytic Index. 
  For complement activation (ISO 10993-4): 
  If the test article was not the entire final finished device or a representative 
sample selection per the ASCA Test Article Prep SOP 
  If a test medium other than those specifically called out in the example ASCA 
summary test report (Refer to Appendix J of this guidance) was used 
  If exposure ratio or conditions other than those specially called out in the 
example ASCA summary test report (Refer to Appendix J of this guidance) 
were used  
       19  Contains Nonbinding Recommendations
 If test medium, negative, positive, and comparator controls did not perform as 
expected, or there was a statistically significant increase in SC5b-9 for test 
article compared to negative or comparator controls. 
VI.  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 estimated17 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
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).
17Rounded to the nearest whole number.
20 Contains Nonbinding Recommendations 
 
Appendix A: Example ASCA Declaration of Conformity 
(DOC) for Biological Evaluation of Medical Devices 
Standards in the ASCA Pilot 
Note: This example is intended to illustrate elements of the Declaration of Conformity per 
FDAs guidance Appropriate Use of Voluntary Consensus Standards in Premarket 
Submissions for Medical Devices that the device manufacturer may submit as part of its 
premarket submission. 
 
Responsible Party 
Name of entity responsible for DOC: ____________________________________________ 
Address of entity responsible for DOC: ___________________________________________ 
 
Product/Device Identification  
 
 
 
All identifying information for the product/device including (e.g., product code(s), device 
marketing name(s), model number(s), etc.).  
 
Statement of Conformity  
 The test results demonstrate that the device is in conformity with the standard(s) listed 
below:18  
 
1.  Title of Standard: (e.g., ISO 10993-10 Third edition 2010-08-01 Biological 
evaluation of medical devices  Part 10: Tests for irritation and skin sensitization)-
___ 
  FDA Recognition #: (e.g., 2-174)_______________________________________ 
  Options Selected 
  Standard included no options  
  Standard included options 
 
 
List of options selected in standard (e.g., Clause 7.3 Guinea pig assays for 
detection of skin sensitization). No information is needed in this section if 
testing is from an ASCA-accredited test laboratory; instead, this section may 
reference the ASCA summary test report provided as supplementary 
documentation.  
  Testing Laboratory Name: (e.g., Testing Laboratory ABC)___________________ 
  ASCA Testing Laboratory Identification Number (as applicable): (e.g., ASCA001) 
  Testing Location(s): (e.g., 1234 Example Road, Silver Spring, MD 20993)______ 
                                                 
18 See section 514(c)(3)(A)(i) of the FD&C Act, cited in Section IV.A.(3)(f) of FDAs guidance Appropriate 
Use of Voluntary Consensus Standards in Premarket Submissions for Medical Device. 
       21  Contains Nonbinding Recommendations 
 
  Testing Date(s): (e.g., Sep 1, 2020  Sep 15, 2020)_________________________ 
  ASCA Accreditation Status on the Date(s) of Testing: 
  Standard (and particular test method) was not in testing laboratorys scope of 
ASCA Accreditation  
  Standard (and particular test method) was in testing laboratorys scope of 
ASCA Accreditation;_________________________________________________ 
  ASCA Accreditation was not suspended 
  ASCA Accreditation was suspended 
 
 
Description of reasons for suspension and their impact on testing results, 
including date(s) of suspension. 
  Supplemental Documentation (see Section V.C. of this guidance for specific 
recommendations):  
  Supplementary documentation is not included  
  Supplementary documentation is included at the following location within the 
submission, and I have checked that there are no differences regarding 
protocol and data between the complete test report and the supplemental 
documentation: (e.g., Appendix A of this premarket 
submission)________________________________________ 
 
<Repeat for each standard in DOC> 
 
Limitations on Validity of DOC 
       22  Contains Nonbinding Recommendations 
 
 
 
 
Description of any limitation on the validity of the DOC (e.g., how long the declaration is valid, 
what was tested, or concessions made about the testing outcomes). For testing from an ASCA-
accredited test laboratory, this should include, at a minimum: 
 
  Information on how the test article compares with the device provided in this 
premarket submission19 (including, selection of representative devices/portions) 
can be found at the following location in this premarket submission: (e.g., Section V. 
pages 45-50)____________ 
  Information on how any concerns communicated by the test lab were resolved can be 
found at the following location in this premarket submission: (e.g., Appendix D of 
this premarket 
submission)_________________________________________________________ 
  Information on how any observations and/or degradations during testing were 
resolved can be found at the following location in this premarket submission: (e.g., 
Appendix D of this premarket 
submission)___________________________________________________________ 
  A statement that the device/test article does not require customized sample 
preparation and/or testing methodologies, or any absorbable or in situ polymerizing 
devices, liquid devices, creams, gels, hydrogel devices, and devices containing 
nanomaterials, as these types of materials are not eligible for biocompatibility 
testing under the ASCA Pilot  
 
 
Signature 
Printed name: ______________________________________________________________ 
Function within entity responsible for DOC: _______________________________________ 
 
___________________________________________________________________________
Signature                                Date 
 
 
 
 
                                                 
19 Please see FDAs guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical 
devices - Part 1: Evaluation and testing within a risk management process" for considerations regarding the use 
of medical devices in their final finished form or a representative test article for biocompatibility testing. 
       23  Contains Nonbinding Recommendations 
 
Appendix B: Example ASCA Summary Test Report for 
Biocompatibility Testing of Medical Devices: Irritation  
Intracutaneous Reactivity (ISO 10993-10) 
Note: This example is intended to illustrate the supplemental documentation that would 
accompany the Declaration of Conformity per FDAs guidance Appropriate Use of 
Voluntary Consensus Standards in Premarket Submissions for Medical Devices. The ASCA 
summary test report is provided by the testing laboratory to the device manufacturer. 
 
Administrative Information 
1.  Testing Laboratory Name: 
2.  ASCA Testing Laboratory  Identification Number:  
3.  Testing Location(s): 
4.  Testing Date(s):  
5.  ASCA Accreditation Status on the Date(s) of Testing: 
  Standard (and particular test method) was *NOT* in testing laboratorys scope of 
ASCA Accreditation20  
  Standard (and particular test method) was in testing laboratorys scope of ASCA 
Accreditation 
  ASCA Accreditation was not suspended 
  ASCA Accreditation was suspended 
 
 
Description of reasons for suspension and their impact on testing results. 
 
ASCA Test Article Prep SOP#:  [ASCATAPrep(date/version)]   
  Test Article was prepared per the above protocol (no deviations/amendments); or 
  Test Article was prepared per the above protocol, with the following 
deviations/amendments21 (e.g., filtering, extract manipulation, pH adjustment): 
 
 
Description of deviations/amendments 
 
  For devices that contain fluid paths only, the Test Article was prepared using only the 
fluid path for extraction  
Extraction Solvent:  
    0.9% Sodium Chloride (SC)   
                                                 
20 See FDAs guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for 
Medical Devices for information regarding supplemental documentation necessary to support FDA-recognized 
consensus standards that are not in a testing laboratorys scope of ASCA Accreditation. 
21 Since deviations/amendments were noted, the complete test report should be included with ASCA Summary 
Test Report during the ASCA Pilot (depending on the information provided, FDA may or may not request to 
review the complete test report). Test Laboratory/Manufacturer may also be requested to provide a rationale to 
support a regulatory decision. 
       24  Contains Nonbinding Recommendations 
 
    Cotton Seed Oil (CSO)/Sesame Oil (SO)     
    Other:22 [DESCRIBE]   
Extraction Ratio:   
    6cm2/ml (<0.5mm thick)   
    3cm2/ml (0.5-1.0mm thick or molded items > 1.0mm) 
    1.25cm2/ml (elastomers > 1.0mm thick)   
    Other:23  [DESCRIBE]   
Extraction Conditions: 
    37C, 72 h   
    50C, 72 h   
    70C, 24 h   
    121C, 1 h   
    Other:24  [DESCRIBE]     
 
Fluid Path Extractions: 
  For fluid path devices or components (where fluids contact the channels in the device or 
component, and then the fluid enters the body), the extraction was conducted using protocols 
specific to fluid path, with the following approach:25  
  Complete fill with agitation 
  Partial fill with agitation (ISO 10993-12 surface/volume ratio) 
  Partial fill with agitation (other surface/volume ratio): [DESCRIBE RATIO USED]   
  Other:  [SUMMARIZE APPROACH]  
  The test article and extract DID NOT change color, and the extract DID NOT appear 
turbid or have particles.  
  There were changes in color/turbidity or particles in the test article and/or extract OR 
there was swelling/degradation of the test article.26  
 
ASCA Test Method SOP #:  [ASCAIntracut(date/version)]   
 
  Test was conducted per the above protocol (no deviations/amendments) and 21 CFR 58; 
or 
                                                 
22 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
23 Ibid 
24 Ibid 
25 The applicability of various approaches (e.g., partial fill versus complete fill) for a particular device may 
impact whether or not a complete test report is requested in addition to the ASCA Summary Test Report. 
26 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
 
       25  Contains Nonbinding Recommendations 
 
  Test was conducted per the above protocol and 21 CFR 58, with the following 
deviations/amendments:27 
 
 
Description of deviations/amendments 
Results:28 
  Test Article  24 hr Results  48 hr Results  72 hr Results  Conclusions 
Animal 1  SC Test  ER^:  0/0/0/0/0  ER:  0/0/0/0/0  ER:  0/0/0/0/0  Performed as 
ED:  0/0/0/0/0  ED:  0/0/0/0/0  ED:  0/0/0/0/0  expected 
  SC Control  ER:  0/0/0/0/0  ER:  0/0/0/0/0  ER:  0/0/0/0/0  Performed as 
ED:  0/0/0/0/0  ED:  0/0/0/0/0  ED:  0/0/0/0/0  expected 
Animal 2  SC Test  ER:  0/0/0/0/0  ER:  0/0/0/0/0  ER:  0/0/0/0/0  Performed as 
ED:  0/0/0/0/0  ED:  0/0/0/0/0  ED:  0/0/0/0/0  expected 
  SC Control  ER:  0/0/0/0/0  ER:  0/0/0/0/0  ER:  0/0/0/0/0  Performed as 
ED:  0/0/0/0/0  ED:  0/0/0/0/0  ED:  0/0/0/0/0  expected 
Animal 3  SC Test  ER:  0/0/0/0/0  ER:  0/0/0/0/0  ER:  0/0/0/0/0  Performed as 
ED:  0/0/0/0/0  ED:  0/0/0/0/0  ED:  0/0/0/0/0  expected 
  SC Control  ER:  0/0/0/0/0  ER:  0/0/0/0/0  ER:  0/0/0/0/0  Performed as 
ED:  0/0/0/0/0  ED:  0/0/0/0/0  ED:  0/0/0/0/0  expected 
Animal 1  SO Test  ER:  1/1/1/1/1  ER: 1/0/1/1/1  ER:  1/0/1/1/1  Performed as 
ED:  0/0/0/0/0  ED:  0/0/0/0/0  ED:  0/0/0/0/0  expected 
  SO Control  ER:  1/1/1/1/1  ER:  1/1/1/1/1  ER:  1/1/0/0/1  Performed as 
ED:  0/0/0/0/0  ED:  0/0/0/0/0  ED:  0/0/0/0/0  expected 
Animal 2  SO Test  ER:  1/1/1/1/1  ER:  1/1/1/1/0  ER:  1/1/1/1/0  Performed as 
ED:  0/0/1/0/0  ED:  0/0/1/0/0  ED:  0/0/0/0/0  expected 
  SO Control  ER:  1/1/1/1/0  ER:  1/1/1/0/1  ER:  1/1/0/0/0  Performed as 
ED:  0/0/1/0/0  ED:  0/0/0/0/0  ED:  0/0/0/0/0  expected 
Animal 3  SO Test  ER:  1/1/1/1/1  ER:  1/1/1/1/1  ER:  1/1/1/1/1  Performed as 
ED:  0/0/0/0/0  ED:  0/0/0/0/0  ED:  0/0/0/0/0  expected 
  SO Control  ER:  1/1/1/1/1  ER:  1/1/1/1/1  ER:  1/1/1/1/1  Performed as 
ED:  0/0/0/0/0  ED:  0/0/0/0/0  ED:  0/0/0/0/0  expected 
  [INSERT ROWS FOR ANY ADDITIONAL REPEAT TEST DATA] 
^ER = erythema grade; ED = edema grade 
                                                 
27 Since deviations/amendments were noted, the complete test report should be included with ASCA Summary 
Test Report during the ASCA Pilot (depending on the information provided, FDA may or may not need to 
review the complete test report). Test Laboratory/Manufacturer may also be requested to provide a rationale to 
support a regulatory decision. 
28 The complete test report should be included with ASCA Summary Test Report during the ASCA Pilot, if the 
overall score differences between the test and control are greater than one (i.e., per ISO 10993-10:2010, Clause 
6.4.7), or if there were non-zero results for any of the sodium chloride control sites in any animal, or results 
greater than 1 for any of the oil control sites in any animal at any timepoint. 
       26  Contains Nonbinding Recommendations 
 
Extract  Overall Test  Overall  Overall Mean  Conclusion 
Group Mean  Control Group  Difference 
Mean  (Test  Control) 
SC  0.0  0.0  0.0  Non-Irritant 
SO  1.0  0.9  0.1  Non-Irritant 
  There were no adverse clinical findings or animal deaths; or 
  The following adverse clinical findings or animal deaths occurred:29 
 
 
Description of adverse clinical findings or animal deaths 
I confirm that: 
  The above summary information includes all original and any retest data; and 
  I have checked that there are no differences between the complete test report and this 
ASCA summary test report. 
 
 
 
Name:  [TYPED NAME POSITION]  Date 
 
 
   
                                                 
29 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
       27  Contains Nonbinding Recommendations 
 
Appendix C: Example ASCA Summary Test Report for 
Biocompatibility Testing of Medical Devices: Cytotoxicity 
 MEM Elution (ISO 10993-5) 
Note: This example is intended to illustrate the supplemental documentation that would 
accompany the Declaration of Conformity per FDAs guidance Appropriate Use of 
Voluntary Consensus Standards in Premarket Submissions for Medical Devices. The ASCA 
summary test report is provided by the testing laboratory to the device manufacturer. 
 
Administrative Information 
1.  Testing Laboratory Name: 
2.  ASCA Testing Laboratory Identification Number:  
3.  Testing Location(s): 
4.  Testing Date(s):  
5.  ASCA Accreditation Status on the Date(s) of Testing: 
  Standard (and particular test method) was *NOT* in testing laboratorys scope of 
ASCA Accreditation30  
  Standard (and particular test method) was in testing laboratorys scope of ASCA 
Accreditation 
  ASCA Accreditation was not suspended 
  ASCA Accreditation was suspended 
 
 
Description of reasons for suspension and their impact on testing results. 
 
ASCA Test Article Prep SOP#:  [ASCATAPrep(date/version)]   
  Test Article was prepared per the above protocol (no deviations/amendments); or 
  Test Article was prepared per the above protocol, with the following 
deviations/amendments31 (e.g., filtering, extract manipulation, pH adjustment): 
 
 
Description of deviations/amendments 
Extraction Solvent:  
    MEM with 5-10% animal serum   
    Other:32 [DESCRIBE]   
                                                 
30 See FDAs guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for 
Medical Devices for information regarding supplemental documentation necessary to support FDA-recognized 
consensus standards that are not in a testing laboratorys scope of ASCA Accreditation. 
31 Since deviations/amendments were noted, the complete test report should be included with ASCA Summary 
Test Report during the ASCA Pilot (depending on the information provided, FDA may or may not request to 
review the complete test report). Test Laboratory/Manufacturer may also be requested to provide a rationale to 
support a regulatory decision. 
32 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
       28  Contains Nonbinding Recommendations 
 
Extraction Ratio:   
    6cm2/ml (<0.5mm thick)   
    3cm2/ml (0.5-1.0mm thick or molded items > 1.0mm) 
    1.25cm2/ml (elastomers > 1.0mm thick)   
    Other:33  [DESCRIBE]   
Extraction Conditions: 
    37C, 24 h   
    37C, 72 h   
    50C, 72 h   
    70C, 24 h   
    121C, 1 h   
    Other:34  [DESCRIBE]     
 
Fluid Path Extractions: 
  For fluid path devices or components (where fluids contact the channels in the device or 
component, and then the fluid enters the body), the extraction was conducted using protocols 
specific to fluid path, with the following approach:35  
  Complete fill with agitation 
  Partial fill with agitation (ISO 10993-12 surface/volume ratio) 
  Partial fill with agitation (other surface/volume ratio): [DESCRIBE RATIO USED]   
  Other:  [SUMMARIZE APPROACH]  
  The test article and extract DID NOT change color, and the extract DID NOT appear 
turbid or have particles.  
  There were changes in color/turbidity or particles in the test article and/or extract OR 
there was swelling/degradation of the test article.36  
ASCA Test Method SOP #:  [######-ASCACytotox(date/version)]   
  Test was conducted per the above protocol (no deviations/amendments) and 21 CFR 58; 
or 
  Test was conducted per the above protocol and 21 CFR 58, with the following 
deviations/amendments:37 
 
 
                                                 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
33 Ibid 
34 Ibid 
35 The applicability of various approaches (e.g., partial fill versus complete fill) for a particular device may 
impact whether or not a complete test report should be included with the ASCA Summary Test Report. 
36 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
37 Since deviations/amendments were noted, the complete test report should be included with ASCA Summary 
Test Report during the ASCA Pilot (depending on the information provided, FDA may or may not request to 
review the complete test report). Test Laboratory/Manufacturer may also be requested to provide a rationale to 
support a regulatory decision. 
       29  Contains Nonbinding Recommendations 
 
Description of deviations/amendments 
 
Results:38 
  24 hr  48 hr  72 hr  Conclusion 
Results  Results  Results 
(optional)  (implants) 
Vehicle Control  Grade 0/0/0  Grade  Grade 0/0/0  Performed as 
0/0/0  expected 
Negative Control HDPE  Grade 0/0/0  Grade  Grade 0/0/0  Performed as 
0/0/0  expected 
Positive Control Latex  Grade 3/3/3  Grade  Grade 4/4/4  Performed as 
4/4/4*  expected 
Test Article Extract (100%  Grade 0/0/0  Grade  Grade 0/0/0  Non-cytotoxic 
neat)  0/0/0 
[INSERT ROWS FOR ANY         
ADDITIONAL TEST 
ARTICLE 
DILUTION/RETEST DATA] 
*based on prior results (once Grade 4 results are observed, subsequent assessment is not 
necessary for cytotoxicity) 
I confirm that: 
  The above summary information includes all original and any retest data; and 
  I have checked that there are no differences between the complete test report and this 
ASCA summary test report. 
 
 
   
Name:  [TYPED NAME POSITION]  Date 
 
 
   
Name:  [TYPED NAME, POSITION]  Date 
   
                                                 
38 The complete test report should be included with ASCA Summary Test Report during the ASCA Pilot if there 
were non-zero results for the test article, vehicle control or negative control, or if there were results less than 3 
for the positive control at any timepoint. 
       30  Contains Nonbinding Recommendations 
 
Appendix D: Example ASCA Summary Test Report for 
Biocompatibility Testing of Medical Devices: Dermal 
Irritation (ISO 10993-10) 
Note: This example is intended to illustrate the supplemental documentation that would 
accompany the Declaration of Conformity per FDAs guidance Appropriate Use of 
Voluntary Consensus Standards in Premarket Submissions for Medical Devices. The ASCA 
summary test report is provided by the testing laboratory to the device manufacturer. 
 
Administrative Information 
1.  Testing Laboratory Name: 
2.  ASCA Testing Laboratory Identification Number:  
3.  Testing Location(s): 
4.  Testing Date(s):  
5.  ASCA Accreditation Status on the Date(s) of Testing: 
  Standard (and particular test method) was *NOT* in testing laboratorys scope of 
ASCA Accreditation39  
  Standard (and particular test method) was in testing laboratorys scope of ASCA 
Accreditation 
  ASCA Accreditation was not suspended 
  ASCA Accreditation was suspended 
 
 
Description of reasons for suspension and their impact on testing results. 
 
ASCA Test Article Prep SOP#:  [ASCATAPrep(date/version)]   
  Test Article was prepared per the above protocol (no deviations/amendments); or 
  Test Article was prepared per the above protocol, with the following 
deviations/amendments40 (e.g., filtering, extract manipulation, pH adjustment): 
 
 
Description of deviations/amendments 
Direct contact 
Test article: 
    Entire final finished device 
  Representative sample selection per SOP 
                                                 
39 See FDAs guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for 
Medical Devices for information regarding supplemental documentation necessary to support FDA-recognized 
consensus standards that are not in a testing laboratorys scope of ASCA Accreditation. 
40 Since deviations/amendments were noted, the complete test report should be included with ASCA Summary 
Test Report during the ASCA Pilot (depending on the information provided, FDA may or may not request to 
review the complete test report). Test Laboratory/Manufacturer may also request to provide a rationale to 
support a regulatory decision. 
       31  Contains Nonbinding Recommendations 
 
 
  Other:41 [DESCRIBE]   
 
Extract testing 
Extraction Solvent:  
    0.9% Sodium Chloride (SC)   
    Cotton Seed Oil (CSO)/Sesame Oil (SO)     
    Other:42 [DESCRIBE]   
Extraction Ratio:   
    6cm2/ml (<0.5mm thick)   
    3cm2/ml (0.5-1.0mm thick or molded items > 1.0mm) 
    1.25cm2/ml (elastomers > 1.0mm thick)   
    Other:43 [DESCRIBE]   
Extraction Conditions: 
  37C, 72 h   
    50C, 72 h   
    70C, 24 h   
    121C, 1 h   
    Other:44 [DESCRIBE]     
 
Fluid Path Extractions: 
  For fluid path devices or components (where fluids contact the channels in the device or 
component, and then the fluid enters the body), the extraction was conducted using protocols 
specific to fluid path, with the following approach:45  
  Complete fill with agitation 
  Partial fill with agitation (ISO 10993-12 surface/volume ratio) 
  Partial fill with agitation (other surface/volume ratio): [DESCRIBE RATIO USED]   
  Other:  [SUMMARIZE APPROACH]  
  The test article and extract DID NOT change color, and the extract DID NOT appear 
turbid or have particles.  
  There were changes in color/turbidity or particles in the test article and/or extract OR 
there was swelling/degradation of the test article.46  
 
                                                 
41 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
42 Ibid 
43 Ibid 
44 Ibid 
45 The applicability of various approaches (e.g., partial fill versus complete fill) for a particular device may 
impact whether or not a complete test report should be included with the ASCA Summary Test Report. 
46 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
       32  Contains Nonbinding Recommendations 
 
ASCA Test Method SOP #:  [ASCADermalIrri(date/version)]   
  Test was conducted per the above protocol (no deviations/amendments) and 21 CFR 58; 
or 
  Test was conducted per the above protocol and 21 CFR 58, with the following 
deviations/amendments:47 
 
 
Description of deviations/amendments 
Results:48 
Table 1 Summary of Scores for Dermal Irritation* 
Animal  Test/Control  Score @ 1hr  Score @  Score @  Score @ 
Number  Article Sites  24hr  48hr  72hr 
ER  ED  ER  ED  ER  ED  ER  ED 
1  Test Site-1  0  0  0  0  0  0  0  0 
Test Site-2  1  0  0  0  0  0  0  0 
Control Site-1  0  0  0  0  0  0  0  0 
Control Site-2  0  0  0  0  0  0  0  0 
2  Test Site-1  0  0  0  0  0  0  0  0 
Test Site-2  0  0  0  0  0  0  0  0 
Control Site-1  0  0  0  0  0  0  0  0 
Control Site-2  0  0  0  0  0  0  0  0 
3  Test Site-1  0  0  0  0  0  0  0  0 
Test Site-2  0  0  0  0  0  0  0  0 
Control Site-1  0  0  0  0  0  0  0  0 
Control Site-2  0  0  0  0  0  0  0  0 
[INSERT ROWS FOR ANY ADDITIONAL REPEAT TEST DATA] 
*For extract-based tests: animal data49 for both polar and nonpolar test extracts and 
corresponding vehicle controls should be reported.  
                                                 
47 Since deviations/amendments were noted, the complete test report should be included with ASCA Summary 
Test Report during the ASCA Pilot (depending on the information provided, FDA may or may not request to 
review the complete test report). Test Laboratory/Manufacturer may also be requested to provide a rationale to 
support a regulatory decision. 
48 The complete test report should be included with ASCA Summary Test Report during the ASCA Pilot if the 
primary irritation score is calculated using different timepoints besides 24h, 48h and 72h, if there were any non-
zero test or control (e.g., direct contact control: gauze; extract test control: sodium chloride or oil) results at any 
time point.   
49 We support the principles of the 3Rs, to reduce, refine, and replace animal use in testing when feasible. We 
encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable, 
adequate, validated, and feasible. We will consider if such an alternative method could be assessed for 
equivalency to an animal test method. However, these alternative methods would not be eligible for the ASCA 
pilot. See generally: https://www.fda.gov/science-research/advancing-regulatory-science/vi-modernizing-safety-
testing 
       33  Contains Nonbinding Recommendations 
 
^ER = erythema grade; ED = edema grade 
Table 2 Summary of Primary Irritation Index* 
Animal  Test  -  Control  Individual  Combined  Primary  Response  Conclusion 
Number  Score  Score  Primary  Primary  Irritation  Category 
Average  Average  Irritation  Irritation  Index 
Score  Score  (CPIS3) 
(CPIS) 
1  0.0  -  0.0  0.0  0.0  0.0  Negligible  Non-irritant 
2  0.0  -  0.0  0.0 
3  0.0  -  0.0  0.0 
*For extract-based tests: animal data for both polar and nonpolar test extracts and 
corresponding vehicle controls should be reported.  
  There were no adverse clinical findings or animal deaths; or 
  The following adverse clinical findings or animal deaths occurred:50 
 
 
Description of adverse clinical findings or animal deaths 
I confirm that: 
  The above summary information includes all original and any retest data; and 
  I have checked that there are no differences between the complete test report and this 
ASCA summary test report. 
 
 
 
Name:  [TYPED NAME POSITION]  Date 
 
 
 
 
 
 
   
                                                 
50 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
       34  Contains Nonbinding Recommendations 
 
Appendix E: Example ASCA Summary Test Report for 
Biocompatibility Testing of Medical Devices: Guinea Pig 
Maximization Sensitization (ISO 10993-10) 
Note: This example is intended to illustrate the supplemental documentation that would 
accompany the Declaration of Conformity per FDAs guidance Appropriate Use of 
Voluntary Consensus Standards in Premarket Submissions for Medical Devices. The ASCA 
summary test report is provided by the testing laboratory to the device manufacturer. 
 
Administrative Information 
1.  Testing Laboratory Name: 
2.  ASCA Testing Laboratory Identification Number:  
3.  Testing Location(s): 
4.  Testing Date(s):  
5.  ASCA Accreditation Status on the Date(s) of Testing: 
  Standard (and particular test method) was *NOT* in testing laboratorys scope of 
ASCA Accreditation51  
  Standard (and particular test method) was in testing laboratorys scope of ASCA 
Accreditation 
  ASCA Accreditation was not suspended 
  ASCA Accreditation was suspended 
 
 
Description of reasons for suspension and their impact on testing results. 
 
ASCA Test Article Prep SOP#:  [ASCATAPrep(date/version)]   
  Test Article was prepared per the above protocol (no deviations/amendments); or 
  Test Article was prepared per the above protocol, with the following 
deviations/amendments52 (e.g., filtering, extract manipulation, pH adjustment): 
 
 
Description of deviations/amendments 
Extraction Solvent:  
    0.9% Sodium Chloride (SC)   
    Cotton Seed Oil (CSO)/Sesame Oil (SO)     
                                                 
51 See FDAs guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for 
Medical Devices for information regarding supplemental documentation necessary to support FDA-recognized 
consensus standards that are not in a testing laboratorys scope of ASCA Accreditation. 
52 Since deviations/amendments were noted, the complete test report should be included with ASCA Summary 
Test Report during the ASCA Pilot (depending on the information provided, FDA may or may not request to 
review the complete test report). Test Laboratory/Manufacturer may also be requested to provide a rationale to 
support a regulatory decision. 
       35  Contains Nonbinding Recommendations 
 
    Other:53 [DESCRIBE]   
Extraction Ratio:   
    6cm2/ml (<0.5mm thick)   
    3cm2/ml (0.5-1.0mm thick or molded items > 1.0mm) 
    1.25cm2/ml (elastomers > 1.0mm thick)   
    Other:54  [DESCRIBE]   
Extraction Conditions: 
  37C, 72 h   
    50C, 72 h   
    70C, 24 h   
    121C, 1 h   
    Other:55  [DESCRIBE]     
 
Fluid Path Extractions: 
  For fluid path devices or components (where fluids contact the channels in the device or 
component, and then the fluid enters the body), the extraction was conducted using protocols 
specific to fluid path, with the following approach:56  
  Complete fill with agitation 
  Partial fill with agitation (ISO 10993-12 surface/volume ratio) 
  Partial fill with agitation (other surface/volume ratio): [DESCRIBE RATIO USED]   
  Other:  [SUMMARIZE APPROACH]  
  The test article and extract DID NOT change color, and the extract DID NOT appear 
turbid or have particles.  
  There were changes in color/turbidity or particles in the test article and/or extract OR 
there was swelling/degradation of the test article.57     
                                                 
53 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also request to provide a rationale to support a regulatory decision. 
54 Ibid 
55 Ibid 
56 The applicability of various approaches (e.g., partial fill versus complete fill) for a particular device may 
impact whether or not a complete test report should be included with the ASCA Summary Test Report. 
57 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
       36  Contains Nonbinding Recommendations 
 
 
ASCA Test Method SOP #:  [ASCAMaximizationSensi(date/version)]   
  Test was conducted per the above protocol (no deviations/amendments) and 21 CFR 58; 
or 
  Test was conducted per the above protocol and 21 CFR 58, with the following 
deviations/amendments:58 
 
 
Description of deviations/amendments 
   
                                                 
58 Since deviations/amendments were noted, the complete test report should be included with ASCA Summary 
Test Report during the ASCA Pilot (depending on the information provided, FDA may or may not request to 
review the complete test report). Test Laboratory/Manufacturer may also be requested to provide a rationale to 
support a regulatory decision. 
       37  Contains Nonbinding Recommendations 
 
Results:59  
Table 1 Summary of Scores for Sensitization 
Group  Animal  24hrs  48hrs  Sensitizatio Conclusio
Numbe n  n 
r  Frequency 
Contr Tes Contr Tes    
ol Site  t  ol Site  t 
Site  Site 
SC Test  1  0  0  0  0  0%  Non-
2  0  0  0  0  sensitizer 
3  0  0  0  0 
4  0  0  0  0 
5  0  0  0  0 
6  0  0  0  0 
7  0  0  0  0 
8  0  0  0  0 
9  0  0  0  0 
10  0  0  0  0 
SC Control  1  0  0  0  0  0%  Performed 
2  0  0  0  0  as 
3  0  0  0  0  expected 
4  0  0  0  0 
5  0  0  0  0 
SO Test  1  0  0  0  0  0%  Non-
2  0  0  0  0  sensitizer 
3  0  0  0  0 
4  0  0  0  0 
5  0  0  0  0 
6  0  0  0  0 
7  0  0  0  0 
8  0  0  0  0 
9  0  0  0  0 
10  0  0  0  0 
SO Control  1  0  0  0  0  0%  Performed 
2  0  0  0  0  as 
3  0  0  0  0  expected 
4  0  0  0  0 
5  0  0  0  0 
1  0  2  0  2  100% 
2  0  2  0  1 
                                                 
59 The complete test report should be included with ASCA Summary Test Report during the ASCA Pilot, if the 
Magnusson and Kligman grades of 1 or greater observed in the test group, provided grades of less than 1 are 
seen in control animals (i.e., per ISO 10993-10:2010, Clause 7.5.6). 
       38  Contains Nonbinding Recommendations 
 
Dinitrochlorobenze 3  0  2  0  3  Performed 
ne (DNCB) Positive  4  0  2  0  2  as 
Control*   5  0  2  0  2  expected 
[INSERT ROWS FOR ANY ADDITIONAL REPEAT TEST DATA] 
*Periodic/concurrent positive control study 
  Positive control induction concentration:  [DESCRIBE] 
  Positive control challenge concentration:  [DESCRIBE] 
  The same source, strain, and treatment methods used for positive control testing and done 
within 3 months of test article test date 
 The following differences in source, strain, treatment methods or timing of the positive 
control occurred:60   
 
 
Description of differences in source, strain, treatment methods, or timing of the positive 
control. 
   
  There were no adverse clinical findings or animal deaths; or 
  The following adverse clinical findings or animal deaths occurred: 61 
 
 
Description of adverse clinical findings or animal deaths. 
I confirm that: 
  The above summary information includes all original and any retest data; and 
  I have checked that there are no differences between the complete test report and this 
ASCA summary test report. 
 
 
 
 
Name:  [TYPED NAME POSITION]  Date 
 
 
 
 
   
                                                 
60 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
61 Ibid 
       39  Contains Nonbinding Recommendations 
 
Appendix F: Example ASCA Summary Test Report for 
Biocompatibility Testing of Medical Devices: Closed Patch 
Sensitization (ISO 10993-10)   
Note: This example is intended to illustrate the supplemental documentation that would 
accompany the Declaration of Conformity per FDAs guidance Appropriate Use of 
Voluntary Consensus Standards in Premarket Submissions for Medical Devices. The ASCA 
summary test report is provided by the testing laboratory to the device manufacturer. 
 
Administrative Information 
1.  Testing Laboratory Name: 
2.  ASCA Testing Laboratory Identification Number:  
3.  Testing Location(s): 
4.  Testing Date(s):  
5.  ASCA Accreditation Status on the Date(s) of Testing: 
  Standard (and particular test method) was *NOT* in testing laboratorys scope of 
ASCA Accreditation62  
  Standard (and particular test method) was in testing laboratorys scope of ASCA 
Accreditation 
  ASCA Accreditation was not suspended 
  ASCA Accreditation was suspended 
 
 
Description of reasons for suspension and their impact on testing results. 
 
ASCA Test Article Prep SOP#:  [ASCATAPrep(date/version)]   
  Test Article was prepared per the above protocol (no deviations/amendments); or 
  Test Article was prepared per the above protocol, with the following 
deviations/amendments63 (e.g., filtering, extract manipulation, pH adjustment): 
 
 
Description of deviations/amendments 
Direct contact 
Test article: 
    Entire final finished device 
  Representative sample selection per SOP 
                                                 
62 See FDAs guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for 
Medical Devices for information regarding supplemental documentation necessary to support FDA-recognized 
consensus standards that are not in a testing laboratorys scope of ASCA Accreditation. 
63 Since deviations/amendments were noted, the complete test report should be included with ASCA Summary 
Test Report during the ASCA Pilot (depending on the information provided, FDA may or may not request to 
review the complete test report). Test Laboratory/Manufacturer may also be requested to provide a rationale to 
support a regulatory decision. 
       40  Contains Nonbinding Recommendations 
 
  Other:64[DESCRIBE]   
 
Extract testing 
Extraction Solvent:  
    0.9% Sodium Chloride (SC)   
    Cotton Seed Oil (CSO)/Sesame Oil (SO)     
    Other:65 [DESCRIBE]   
Extraction Ratio:   
    6cm2/ml (<0.5mm thick)   
    3cm2/ml (0.5-1.0mm thick or molded items > 1.0mm) 
    1.25cm2/ml (elastomers > 1.0mm thick)   
    Other:66  [DESCRIBE]   
Extraction Conditions: 
  37C, 72 h   
    50C, 72 h   
    70C, 24 h   
    121C, 1 h   
    Other:67  [DESCRIBE]     
 
Fluid Path Extractions: 
  For fluid path devices or components (where fluids contact the channels in the device or 
component, and then the fluid enters the body), the extraction was conducted using protocols 
specific to fluid path, with the following approach:68  
  Complete fill with agitation 
  Partial fill with agitation (ISO 10993-12 surface/volume ratio) 
  Partial fill with agitation (other surface/volume ratio): [DESCRIBE RATIO USED]   
  Other:  [SUMMARIZE APPROACH]  
  The test article and extract DID NOT change color, and the extract DID NOT appear 
turbid or have particles.  
  There were changes in color/turbidity or particles in the test article and/or extract OR 
there was swelling/degradation of the test article.69 
 
ASCA Test Method SOP #:  [ASCAPatchSens(date/version)]   
                                                 
64 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
65 Ibid 
66 Ibid 
67 Ibid 
68 The applicability of various approaches (e.g., partial fill versus complete fill) for a particular device may 
impact whether or not a complete test report should be included with the ASCA Summary Test Report. 
69 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
       41  Contains Nonbinding Recommendations 
 
  Test was conducted per the above protocol (no deviations/amendments) and 21 CFR 58; 
or 
  Test was conducted per the above protocol and 21 CFR 58, with the following 
deviations/amendments:70 
 
 
Description of deviations/amendments 
Results:71 
Table 1 Summary of Scores for Sensitization* 
Group  Animal  24hrs  48hrs  Sensitizatio Conclusio
Numbe n  n 
r  Frequency 
Contr Tes Contr Tes    
ol Site  t  ol Site  t 
Site  Site 
Test  1  0  0  0  0  0%  Non-
2  0  0  0  0  sensitizer 
3  0  0  0  0 
4  0  0  0  0 
5  0  0  0  0 
6  0  0  0  0 
7  0  0  0  0 
8  0  0  0  0 
9  0  0  0  0 
10  0  0  0  0 
Gauze Negative  1  0  0  0  0  0%  Performed 
Control  2  0  0  0  0  as 
  3  0  0  0  0  expected 
4  0  0  0  0 
5  0  0  0  0 
Dinitrochlorobenze 1  0  2  0  2  100%  Performed 
ne (DNCB) Positive  2  0  2  0  1  as 
Control**  3  0  2  0  3  expected 
4  0  2  0  2 
5  0  2  0  2 
                                                 
70 Since deviations/amendments were noted, the complete test report should be included with ASCA Summary 
Test Report during the ASCA Pilot (depending on the information provided, FDA may or may not request to 
review the complete test report). Test Laboratory/Manufacturer may also be requested to provide a rationale to 
support a regulatory decision. 
71 The complete test report should be included with ASCA Summary Test Report during the ASCA Pilot if the 
Magnusson and Kligman grades of 1 or greater observed in the test group, provided grades of less than 1 are 
seen in negative control animals (i.e., per ISO 10993-10:2010, Clause 7.5.6), or the sodium chloride and oil 
vehicle controls are > Grade 0. 
       42  Contains Nonbinding Recommendations 
 
[INSERT ROWS FOR ANY ADDITIONAL REPEAT TEST DATA] 
*For extract-based tests: animal data for both polar and nonpolar test extracts and 
corresponding vehicle controls should be reported.  
**Periodic/concurrent positive control study 
  Positive control induction concentration:  [DESCRIBE] 
  Positive control challenge concentration:  [DESCRIBE] 
  The same source, strain, and treatment methods used for positive control testing and done 
within 3 months of test article test date 
 The following differences in source, strain, treatment methods or timing of the positive 
control occurred: 72 
 
 
Description of differences in source, strain, treatment methods, or timing of the positive 
control 
 
  There were no adverse clinical findings or animal deaths; or 
  The following adverse clinical findings or animal deaths occurred:73 
 
 
Description of adverse clinical findings or animal deaths 
I confirm that: 
  The above summary information includes all original and any retest data; and 
  I have checked that there are no differences between the complete test report and this 
ASCA summary test report. 
 
 
 
 
Name:  [TYPED NAME POSITION]  Date 
 
 
   
                                                 
72 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
73 Ibid 
       43  Contains Nonbinding Recommendations 
 
Appendix G: Example ASCA Summary Test Report for 
Biocompatibility Testing of Medical Devices: Acute 
Systemic Toxicity (ISO 10993-11) 
Note: This example is intended to illustrate the supplemental documentation that would 
accompany the Declaration of Conformity per FDAs guidance Appropriate Use of 
Voluntary Consensus Standards in Premarket Submissions for Medical Devices. The ASCA 
summary test report is provided by the testing laboratory to the device manufacturer. 
 
Administrative Information 
1.  Testing Laboratory Name: 
2.  ASCA Testing Laboratory Identification Number:  
3.  Testing Location(s): 
4.  Testing Date(s):  
5.  ASCA Accreditation Status on the Date(s) of Testing: 
  Standard (and particular test method) was *NOT* in testing laboratorys scope of 
ASCA Accreditation74  
  Standard (and particular test method) was in testing laboratorys scope of ASCA 
Accreditation 
  ASCA Accreditation was not suspended 
  ASCA Accreditation was suspended 
 
 
Description of reasons for suspension and their impact on testing results. 
 
ASCA Test Article Prep SOP#:  [ASCATAPrep(date/version)]   
  Test Article was prepared per the above protocol (no deviations/amendments); or 
  Test Article was prepared per the above protocol, with the following 
deviations/amendments75 (e.g., filtering, extract manipulation, pH adjustment): 
 
 
Description of deviations/amendments 
Extraction Solvent:  
    0.9% Sodium Chloride (SC)   
    Cotton Seed Oil (CSO)/Sesame Oil (SO)     
    Other: 76 [DESCRIBE]   
                                                 
74 See FDAs guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for 
Medical Devices for information regarding supplemental documentation necessary to support FDA-recognized 
consensus standards that are not in a testing laboratorys scope of ASCA Accreditation. 
75 Since deviations/amendments were noted, the complete test report should be included with ASCA Summary 
Test Report during the ASCA Pilot (depending on the information provided, FDA may or may not request to 
review the complete test report). Test Laboratory/Manufacturer may also be requested to provide a rationale to 
support a regulatory decision. 
 
       44  Contains Nonbinding Recommendations 
 
Extraction Ratio:   
    6cm2/ml (<0.5mm thick)   
    3cm2/ml (0.5-1.0mm thick or molded items > 1.0mm) 
    1.25cm2/ml (elastomers > 1.0mm thick)   
    Other:77  [DESCRIBE]   
Extraction Conditions: 
        37C, 72 h   
    50C, 72 h   
    70C, 24 h   
    121C, 1 h   
    Other:78  [DESCRIBE]     
 
Fluid Path Extractions: 
  For fluid path devices or components (where fluids contact the channels in the device or 
component, and then the fluid enters the body), the extraction was conducted using protocols 
specific to fluid path, with the following approach:79  
  Complete fill with agitation 
  Partial fill with agitation (ISO 10993-12 surface/volume ratio) 
  Partial fill with agitation (other surface/volume ratio): [DESCRIBE RATIO USED]   
  Other:  [SUMMARIZE APPROACH]  
  The test article and extract DID NOT change color, and the extract DID NOT appear 
turbid or have particles.  
  There were changes in color/turbidity or particles in the test article and/or extract OR 
there was swelling/degradation of the test article.80  
ASCA Test Method SOP #:  [ASCAAcuteTox(date/version)]   
  Test was conducted per the above protocol (no deviations/amendments) and 21 CFR 58; 
or 
  Test was conducted per the above protocol and 21 CFR 58, with the following 
deviations/amendments:81 
                                                 
 
77 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
78Ibid 
79 The applicability of various approaches (e.g., partial fill versus complete fill) for a particular device may 
impact whether or not a complete test report should be included with the ASCA Summary Test Report. 
80 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
81 Since deviations/amendments were noted, the complete test report should be included with ASCA Summary 
Test Report during the ASCA Pilot (depending on the information provided, FDA may or may not request to 
review the complete test report). Test Laboratory/Manufacturer may also be requested to provide a rationale to 
support a regulatory decision. 
       45  Contains Nonbinding Recommendations 
 
 
 
Description of deviations/amendments 
Results:82 
Table 1 Summary of Test Results83 
Extract  Animal  Body Weight (g)  Weight  Conclusion (Based on Body 
Number  Day 0  Day 1  Day 2  Day 3  Change  Weight and Clinical 
Findings) 
SC  1  20.4  20.8  21.1  21.7  1.3  No acute systemic toxicity 
Test  2  19.6  20.4  20.3  21.7  2.1  No acute systemic toxicity 
3  19.6  19.9  20.1  20.7  1.1  No acute systemic toxicity 
4  20.4  19.8  20.3  21.1  0.7  No acute systemic toxicity 
5  17.9  18.6  19.0  19.7  1.8  No acute systemic toxicity 
SC  1  17.9  19.9  19.8  20.4  2.5  Performed as expected 
Control  2  19.8  20.0  20.9  22.3  2.5  Performed as expected 
3  19.9  20.3  20.8  21.4  1.5  Performed as expected 
4  17.9  17.8  17.9  18.6  0.7  Performed as expected 
5  22.1  22.9  23.1  24.3  2.2  Performed as expected 
SO  1  22.2  22.9  22.8  23.4  1.2  Not systemically toxic  
Test  2  20.2  21.3  21.4  21.8  1.6  Not systemically toxic 
3  19.0  19.2  19.3  20.2  1.2  Not systemically toxic 
4  18.5  19.8  20.5  21.6  3.1  Not systemically toxic 
5  19.4  202.2  19.8  20.0  0.6  Not systemically toxic 
SO  1  19.7  20.2  20.5  21.9  2.2  Not systemically toxic 
Control  2  19.4  19.9  19.7  20.0  0.6  Not systemically toxic 
3  21.2  21.7  22.2  23.6  2.4  Not systemically toxic 
4  20.9  21.7  22.0  23.1  2.2  Not systemically toxic 
5  20.3  21.1  21.6  23.4  3.1  Not systemically toxic 
[INSERT ROWS FOR ANY ADDITIONAL REPEAT TEST DATA] 
  There were no adverse clinical findings or animal deaths; or 
  The following adverse clinical findings or animal deaths occurred:84 
                                                 
82 The complete test report should be included with ASCA Summary Test Report during the ASCA Pilot if 
controls did not perform as expected, any animals were found dead or were euthanized, behavior such as 
convulsions or prostration occurred in any animals, or a body weight loss greater than 10 % occurred in any 
animals. 
83 This is an example of how data from an acute systemic toxicity test could be presented. 
84 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
       46  Contains Nonbinding Recommendations 
 
 
 
Description of adverse clinical findings or animal deaths 
I confirm that: 
  The above summary information includes all original and any retest data; and 
  I have checked that there are no differences between the complete test report and this 
ASCA summary test report. 
 
 
 
Name:  [TYPED NAME POSITION]  Date 
 
 
   
       47  Contains Nonbinding Recommendations 
 
Appendix H: Example ASCA Summary Test Report for 
Biocompatibility Testing of Medical Devices: Material-
Mediated Pyrogenicity (ISO 10993-11 and USP 151)   
Note: This example is intended to illustrate the supplemental documentation that would 
accompany the Declaration of Conformity per FDAs guidance Appropriate Use of 
Voluntary Consensus Standards in Premarket Submissions for Medical Devices. The ASCA 
summary test report is provided by the testing laboratory to the device manufacturer. 
 
Administrative Information 
1.  Testing Laboratory Name: 
2.  ASCA Testing Laboratory Identification Number:  
3.  Testing Location(s): 
4.  Testing Date(s):  
5.  ASCA Accreditation Status on the Date(s) of Testing: 
  Standard (and particular test method) was *NOT* in testing laboratorys scope of 
ASCA Accreditation85  
  Standard (and particular test method) was in testing laboratorys scope of ASCA 
Accreditation 
  ASCA Accreditation was not suspended 
  ASCA Accreditation was suspended 
 
 
Description of reasons for suspension and their impact on testing results. 
 
ASCA Test Article Prep SOP#:  [ASCATAPrep(date/version)]   
  Test Article was prepared per the above protocol (no deviations/amendments); or 
  Test Article was prepared per the above protocol, with the following 
deviations/amendments86  (e.g., filtering, extract manipulation, pH adjustment): 
 
 
Description of deviations/amendments 
Extraction Solvent:  
    0.9% Sodium Chloride (SC)     
    Other:87[DESCRIBE]   
                                                 
85 See FDAs guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for 
Medical Devices for information regarding supplemental documentation necessary to support FDA-recognized 
consensus standards that are not in a testing laboratorys scope of ASCA Accreditation. 
86 Since deviations/amendments were noted, the complete test report should be included with ASCA Summary 
Test Report during the ASCA Pilot (depending on the information provided, FDA may or may not request to 
review the complete test report). Test Laboratory/Manufacturer may also be requested to provide a rationale to 
support a regulatory decision. 
87 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
       48  Contains Nonbinding Recommendations 
 
Extraction Ratio:   
    6cm2/ml (<0.5mm thick)   
    3cm2/ml (0.5-1.0mm thick or molded items > 1.0mm) 
    1.25cm2/ml (elastomers > 1.0mm thick)   
    Other:88  [DESCRIBE]   
Extraction Conditions: 
  37C, 72 h   
    50C, 72 h   
    70C, 24 h   
    121C, 1 h   
    Other:89  [DESCRIBE]     
 
Fluid Path Extractions: 
  For fluid path devices or components (where fluids contact the channels in the device or 
component, and then the fluid enters the body), the extraction was conducted using protocols 
specific to fluid path, with the following approach:90  
  Complete fill with agitation 
  Partial fill with agitation (ISO 10993-12 surface/volume ratio) 
  Partial fill with agitation (other surface/volume ratio): [DESCRIBE RATIO USED]   
  Other:  [SUMMARIZE APPROACH]  
  The test article and extract DID NOT change color, and the extract DID NOT appear 
turbid or have particles.  
  There were changes in color/ turbidity or particles in the test article and/or extract OR 
there was swelling/degradation of the test article.91 
   
                                                 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
88Ibid 
89 Ibid 
90 The applicability of various approaches (e.g., partial fill versus complete fill) for a particular device may 
impact whether or not a complete test report should be included with the ASCA Summary Test Report. 
91 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
       49  Contains Nonbinding Recommendations 
 
ASCA Test Method SOP #:  [ASCAPyrogenicity(date/version)]   
  Test was conducted per the above protocol (no deviations/amendments) and 21 CFR 58; 
or 
  Test was conducted per the above protocol and 21 CFR 58, with the following 
deviations/amendments:92 
 
 
Description of deviations/amendments 
Results:93 
Table 1 Pyrogen Test Data94 
Animal  Baseline  1.0hr  1.5 hr  2.0 hr  2.5 hr  3.0 hr  Temp  Conclusion 
Number  Temp  Temp  Temp  Temp  Temp  Temp  Increase 
(C)  (C)  (C)  (C)  (C)  (C)  (C) 
1 (test)  39.0  39.1  39.1  38.9  38.8  39.1  0.1  Non-
pyrogenic 
2 (test)  39.3  39.3  39.1  38.8  39.1  39.1  0.0  Non-
pyrogenic 
3 (test)  39.0  38.7  38.8  39.1  39.4  39.4  0.4  Non-
pyrogenic 
[INSERT ROWS FOR ANY ADDITIONAL REPEAT TEST DATA] 
  There were no adverse clinical findings or animal deaths; or 
  The following adverse clinical findings or animal deaths occurred:95 
 
 
Description of adverse clinical findings or animal deaths 
I confirm that: 
  The above summary information includes all original and any retest data; and 
  I have checked that there are no differences between the complete test report and this 
ASCA summary test report. 
 
 
                                                 
92 Since deviations/amendments were noted,  the complete test report should be included with ASCA Summary 
Test Report during the ASCA Pilot (depending on the information provided, FDA may or may not request to 
review the complete test report). Test Laboratory/Manufacturer may also be requested to provide a rationale to 
support a regulatory decision. 
93 The complete test report should be included with ASCA Summary Test Report during the ASCA Pilot if any 
rabbit has a baseline temperature exceeding 39.8oC or if any rabbit has a temperature rise 0.5C. 
94 This is an example of how data from a material-mediated pyrogenicity test could be presented. 
95 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
       50  Contains Nonbinding Recommendations 
 
 
Name:  [TYPED NAME POSITION]  Date 
 
 
       51  Contains Nonbinding Recommendations 
 
Appendix I: Example ASCA Summary Test Report for 
Biocompatibility Testing of Medical Devices: Direct and 
Indirect Hemolysis (ISO 10993-4 and ASTM F756) 
Note: This example is intended to illustrate the supplemental documentation that would 
accompany the Declaration of Conformity per FDAs guidance Appropriate Use of 
Voluntary Consensus Standards in Premarket Submissions for Medical Devices. The ASCA 
summary test report is provided by the testing laboratory to the device manufacturer. 
 
Administrative Information 
1.  Testing Laboratory Name: 
2.  ASCA Testing Laboratory Identification Number:  
3.  Testing Location(s): 
4.  Testing Date(s):  
5.  ASCA Accreditation Status on the Date(s) of Testing: 
  Standard (and particular test method) was *NOT* in testing laboratorys scope of 
ASCA Accreditation96  
  Standard (and particular test method) was in testing laboratorys scope of ASCA 
Accreditation 
  ASCA Accreditation was not suspended 
  ASCA Accreditation was suspended 
 
 
Description of reasons for suspension and their impact on testing results. 
 
ASCA Test Article Prep SOP#:  [ASCATAPrep(date/version)]   
  Test Article was prepared per the above protocol (no deviations/amendments); or 
  Test Article was prepared per the above protocol, with the following 
deviations/amendments97  (e.g., filtering, extract manipulation, pH adjustment): 
 
 
Description of deviations/amendments 
Extract testing 
Extraction Solvent:  
    Magnesium and Calcium Free PBS     
                                                 
96 See FDAs guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for 
Medical Devices for information regarding supplemental documentation necessary to support FDA-recognized 
consensus standards that are not in a testing laboratorys scope of ASCA Accreditation. 
97 Since deviations/amendments were noted, the complete test report should be included with ASCA Summary 
Test Report during the ASCA Pilot (depending on the information provided, FDA may or may not request to 
review the complete test report). Test Laboratory/Manufacturer may also be requested to provide a rationale to 
support a regulatory decision. 
       52  Contains Nonbinding Recommendations 
 
    Other:98 [DESCRIBE]   
Extraction Ratio:   
    6cm2/ml (<0.5mm thick)   
    3cm2/ml (0.5-1.0mm thick or molded items > 1.0mm) 
    1.25cm2/ml (elastomers > 1.0mm thick)   
    Other:99  [DESCRIBE]   
Extraction Conditions: 
  37C, 72 h   
    50C, 72 h   
    70C, 24 h   
    121C, 1 h   
    Other:100  [DESCRIBE]     
 
Fluid Path Extractions: 
  For fluid path devices or components (where fluids contact the channels in the device or 
component, and then the fluid enters the body), the extraction was conducted using protocols 
specific to fluid path, with the following approach:101  
  Complete fill with agitation 
  Partial fill with agitation (ISO 10993-12 surface/volume ratio) 
  Partial fill with agitation (other surface/volume ratio): [DESCRIBE RATIO USED]   
  Other:  [SUMMARIZE APPROACH]  
  The test article and extract DID NOT change color, and the extract DID NOT appear 
turbid or have particles.  
  There were changes in color/turbidity or particles in the test article and/or extract OR 
there was swelling/degradation of the test article.102  
Direct Contact 
Test article: 
    Entire final finished device 
  Representative sample selection per SOP 
  Other:103 [DESCRIBE]   
Diluent:   
    Magnesium and Calcium Free PBS     
                                                 
98 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
99 Ibid 
100 Ibid 
101 The applicability of various approaches (e.g., partial fill versus complete fill) for a particular device may 
impact whether or not a complete test report should be included with the ASCA Summary Test Report. 
102In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
103 Ibid 
       53  Contains Nonbinding Recommendations 
 
    Other:104[DESCRIBE]   
Exposure Ratio:   
    6cm2/ml (<0.5mm thick)   
    3cm2/ml (0.5-1.0mm thick or molded items > 1.0mm)   
    Other:105  [DESCRIBE]   
  The test article and supernatant DID NOT change color, and the supernatant DID NOT 
appear turbid or have particles.  
  There were changes in color/turbidity or particles in the supernatant OR there was 
swelling/degradation of the test article.106 
ASCA Test Method SOP #:  [ASCAHemolysis(date/version)]   
  Test was conducted per the above protocol (no deviations/amendments) and 21 CFR 58; 
or 
  Test was conducted per the above protocol and 21 CFR 58, with the following 
deviations/amendments: 107 
 
 
Description of deviations/amendments 
 
 
                                                 
104 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
105 Ibid 
106 Ibid 
107 Since deviations/amendments were noted, the complete test report should be included with ASCA Summary 
Test Report during the ASCA Pilot (depending on the information provided, FDA may or may not request to 
review the complete test report). Test Laboratory/Manufacturer may also be requested to provide a rationale to 
support a regulatory decision.  
       54  Contains Nonbinding Recommendations 
 
Results:108 
Table 1 Hemolysis test results109 
Extract Hemolysis   
Sample  Absorbance  Blank corrected % hemolysis  Mean  Hemolytic Index (%)  Conclusions 
  Blank 
Corrected 
Hemolysis 
Replicate  Replicate  Replicate  Replicate  Replicate  Replicate     
(%) 
#1  #2  #3  #1  #2  #3 
Blank  Performed 
0.0022  0.0019  0.0026  -0.01  -0.08  0.09  0.00  - 
as expected 
Negative  Performed 
0.0020  0.0018  0.0019  -0.06  -0.11  -0.08  -0.08  - 
Control  as expected 
Positive  Performed 
0.3233  0.3258  0.3261  79.68  80.30  80.37  80.11  80.20 
Control  as expected 
Test  Non-
0.0019  0.0015  0.0015  -0.08  -0.18  -0.18  -0.15  -0.07 
hemolytic 
Direct Hemolysis 
Sample  Absorbance  Blank corrected % hemolysis  Mean  Hemolytic Index (%)  Conclusions 
  Blank 
Corrected 
Hemolysis 
(%) 
  Replicate  Replicate  Replicate  Replicate  Replicate  Replicate       
#1  #2  #3  #1  #2  #3 
                                                 
108 The complete test report should be included with ASCA Summary Test Report during the ASCA Pilot if negative and positive controls did not perform as 
expected, the negative control, test article, and blank had absorbance values of 0.000 for all replicates, or test article scores of 2% HI. 
109 This is an example of how data from a hemolysis test could be presented. 
       55  Contains Nonbinding Recommendations 
 
Blank  Performed 
0.0057  0.0059  0.0051  0.03  0.08  -0.12  0.00  - 
as expected 
Negative  Performed 
0.0074  0.0084  0.0103  0.46  0.71  1.18  0.78  - 
Control  as expected 
Positive  Performed 
0.3732  0.3736  0.3752  91.99  92.09  92.49  92.19  91.41 
Control  as expected 
Test  Non-
0.0096  0.0091  0.0089  1.01  0.88  0.83  0.91  0.13 
hemolytic 
 
[INSERT ROWS FOR ANY ADDITIONAL REPEAT TEST DATA]
       56  Contains Nonbinding Recommendations 
 
 
I confirm that: 
  The above summary information includes all original and any retest data; and 
  I have checked that there are no differences between the complete test report and this 
ASCA summary test report. 
 
 
 
Name:  [TYPED NAME POSITION]  Date 
 
 
 
   
       57  Contains Nonbinding Recommendations 
 
Appendix J: Example ASCA Summary Test Report for 
Biocompatibility Testing of Medical Devices: Complement 
Activation (ISO 10993-4) 
Note: This example is intended to illustrate the supplemental documentation that would 
accompany the Declaration of Conformity per FDAs guidance Appropriate Use of 
Voluntary Consensus Standards in Premarket Submissions for Medical Devices. The ASCA 
summary test report is provided by the testing laboratory to the device manufacturer. 
 
Administrative Information 
1.  Testing Laboratory Name: 
2.  ASCA Testing Laboratory Identification Number:  
3.  Testing Location(s): 
4.  Testing Date(s):  
5.  ASCA Accreditation Status on the Date(s) of Testing: 
  Standard (and particular test method) was *NOT* in testing laboratorys scope of 
ASCA Accreditation110  
  Standard (and particular test method) was in testing laboratorys scope of ASCA 
Accreditation 
  ASCA Accreditation was not suspended 
  ASCA Accreditation was suspended 
 
 
Description of reasons for suspension and their impact on testing results. 
 
ASCA Test Article Prep SOP#:  [ASCATAPrep(date/version)]   
  Test Article was prepared per the above protocol (no deviations/amendments); or 
  Test Article was prepared per the above protocol, with the following 
deviations/amendments111  (e.g., filtering, extract manipulation, pH adjustment): 
 
 
Description of deviations/amendments 
Test article: 
    Entire final finished device 
  Representative sample selection per SOP 
                                                 
110 See FDAs guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for 
Medical Devices for information regarding supplemental documentation necessary to support FDA-recognized 
consensus standards that are not in a testing laboratorys scope of ASCA Accreditation. 
111 Since deviations/amendments were noted, the complete test report should be included with ASCA Summary 
Test Report during the ASCA Pilot (depending on the information provided, FDA may or may not request to 
review the complete test report). Test Laboratory/Manufacturer may also be requested to provide a rationale to 
support a regulatory decision. 
       58  Contains Nonbinding Recommendations 
 
  Other: 112[DESCRIBE]   
Test Medium:   
    Normal Human Serum 
     Human Plasma 
    Whole Blood 
    Other:113[DESCRIBE]   
Exposure Ratio:   
    6cm2/ml (<0.5mm thick)   
    3cm2/ml (0.5-1.0mm thick or molded items > 1.0mm)   
    Other:114  [DESCRIBE]   
Exposure Conditions: 
    37C for 60-90 min     
    Other:115  [DESCRIBE]     
  The test article and supernatant DID NOT change color, and the supernatant DID NOT 
appear turbid or have particles.  
  There were changes in color/turbidity or particles in the supernatant OR there was 
swelling/degradation of the test article.116 
   
                                                 
112 In this situation, the complete test report should be included with ASCA Summary Test Report during the 
ASCA Pilot (depending on the information provided, FDA may or may not request to review the complete test 
report). Test Laboratory/Manufacturer may also be requested to provide a rationale to support a regulatory 
decision. 
113Ibid 
114 Ibid 
115 Ibid 
116 Ibid 
       59  Contains Nonbinding Recommendations 
 
ASCA Test Method SOP #:  [ASCAComplement(date/version)]   
  Test was conducted per the above protocol (no deviations/amendments) and 21 CFR 58; 
or 
  Test was conducted per the above protocol and 21 CFR 58, with the following 
deviations/amendments:117 
 
 
Description of deviations/amendments 
Results:118 
Table 1 SC5b-9 Protein Concentration (ng/mL)119 
Samples  Dilution  Concentration (ng/mL)   
Replicate #1  Replicate #2  Replicate #3  Mean   Std   Conclusion 
 
Test Article  1:160  208  216  212  212  3.8  Not a 
  complement 
activator* 
Test Medium  1:160  205  207  208  207  1.5  Performed 
Control  as expected 
Negative  1:160  206  205  204  205  1.1  Performed 
Control  as expected 
Material 
Positive  1:160  683  693  688  688  4.8  Performed 
Control  as expected 
Material120 
Cobra Venom  1:8000  10326  10567  10519  10471  127  Performed 
Factor  as expected 
Positive 
Control121 
US marketed  1:160  210  215  223  216  6.6  Performed 
comparator  as expected 
(optional) 
[INSERT ROWS FOR ANY ADDITIONAL REPEAT TEST DATA] 
*not statistically different from negative or comparator controls 
 
                                                 
117 Since deviations/amendments were noted, the complete test report should be included with ASCA Summary 
Test Report during the ASCA Pilot (depending on the information provided, FDA may or may not request to 
review the complete test report). Test Laboratory/Manufacturer may also be requested to provide a rationale to 
support a regulatory decision. 
118 The complete test report should be included with ASCA Summary Test Report during the ASCA Pilot if test 
medium, negative, positive, and comparator controls did not perform as expected, or there was a statistically 
significant increase in SC5b-9 for test article compared to negative or comparator controls. 
119 This is an example of how data from a complement activation test could be presented. 
120 Depending on the positive control used, this row may be relevant. 
121 Ibid 
       60  Contains Nonbinding Recommendations 
 
I confirm that: 
  The above summary information includes all original and any retest data; and 
  I have checked that there are no differences between the complete test report and this 
ASCA summary test report. 
 
 
 
Name:  [TYPED NAME POSITION]  Date 
 
 
 
       61