This page outlines testing information that should be included in a submission to the FDA. In addition to the information provided on this page, refer to:
- Standards and Conformity Assessment Program and the resources listed on the page for information about the appropriate use of consensus standards.
- Accreditation Scheme for Conformity Assessment (ASCA) for information about the accreditation of testing laboratories to perform premarket testing.
Unless noted otherwise, content on this page comes from Attachment E in Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," also referred to as the FDA's Biocompatibility Guidance on Use of ISO 10993-1.
On this page:
- Test reports
- Test article preparation
- Test parameters and acceptance criteria
- Analysis of results
"Whenever biocompatibility or chemical characterization testing information is included in a submission, the FDA recommends that complete test reports be provided for all tests performed unless testing is conducted under the ASCA program and it is determined that an ASCA Summary Test Report is sufficient or a declaration of conformity without supplemental information can be appropriately provided."
- For example, see how ASCA Summary Test Reports can be used with a declaration of conformity for some biocompatibility testing in the biocompatibility standards-specific guidance: Biocompatibility Testing of Medical Devices- Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.
Note: "The ISO 10993 series of standards do not specify either a method or test outcome, because these standards are both compendia and guidance. As such, these standards allow one to select different tests and methods, and do not necessarily include acceptance criteria. Therefore, to support a declaration of conformity and for FDA to assess conformance, for any tests selected under the ISO 10993 paradigm, the rationale for the test battery selected and the criteria used to determine acceptance should be provided. It has been FDA's experience that test reports often address this, and raw data is usually not necessary. There may be other testing for which a declaration of conformity can be submitted to FDA without supplemental information."
[SOURCE: FDA's Biocompatibility Guidance on Use of ISO 10993-1]
"Test reports for GLP studies must address the reporting requirements of 21 CFR 58 and all test reports (for both GLP and non-GLP studies) should also include the sections described below. Test reports should address the reporting provisions of any referenced standards, as well as the information outlined below."
"As described in Section V.A" of the FDA's Biocompatibility Guidance on Use of ISO 10993-1, "the test report should identify the test specimen; if the test article is not the medical device in its final finished form, a justification for the test article used should be provided either in the test report or in the submission to FDA" (See Attachment F of the FDA's Biocompatibility Guidance on Use of ISO 10993-1).
"If the test uses extracts, the report should explain how those extracts were prepared, and indicate the appearance of the extract (color, cloudy versus clear, and presence of particulates)."
Note: As discussed in ISO 10993-1, any justification should include a risk analysis, which "begins with identification and characterization of the indirect and direct tissue-contacting materials and components of the medical device. This should be done based on the final form of the medical device in its manufactured state, taking into account the presence of any manufacturing additives, processing aids or other potential contaminants such as sterilant residues."
[SOURCE: ISO 10993-1:2018, B.3.1.2; see also Attachment F of the FDA's Biocompatibility Guidance on Use of ISO 10993-1 for the Component and Device Documentation Examples Test Method]
"The test report should provide a summary of the method used. If the method used is not in a published guidance document or FDA-recognized standard, a complete description of the method should be provided. If the test method is a modified version of a method in a published guidance document or FDA-recognized standard, the test report should include an explanation of the differences and their potential impact on the interpretation of the results."
"The test report should identify any protocol deviations and their impact on the conclusions drawn from the test."
"The test report should identify the test parameters and acceptance criteria applied. If the test method is not in accordance with a published guidance document or FDA-recognized standard that includes defined acceptance criteria, a rationale for the acceptance criteria should be provided."
"The test report should provide a summary of the test results and include tables with each data point" (for example, absorbance values, grades, representative images) "and statistical analyses," if applicable. "For example, the test report for hemolysis testing per ASTM F756 should include a description of the test, blank, positive, and negative supernatant conditions, in addition to the absorbance and percent hemolysis data."
"For any test in which the results indicate a potential toxicity, the report should include a discussion of any test-specific issues that might have affected results."
"The test report should describe the conclusions drawn from the test results. The clinical relevance of the study conclusions should be described in the test report or in the submission to FDA."