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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 2-277
ASTM F813-20 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
1.1 This practice covers a reference method of direct contact cell culture testing which may be used in evaluating the cytotoxic potential of materials for use in the construction of medical materials and devices.

1.2 This practice may be used either directly to evaluate materials or as a reference against which other cytotoxicity test methods may be compared.

1.3 This is one of a series of reference test methods for the assessment of cytotoxic potential, employing different techniques.

1.4 Assessment of cytotoxicity is one of several tests employed in determining the biological response to a material, as recommended in Practice F748.

1.5 The L-929 cell line was chosen because it has a significant history of use in assays of this type. This is not intended to imply that its use is preferred; only that the L-929 is a well characterized, readily available, established cell line that has demonstrated reproducible results in several laboratories.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ASTM F813-07 (Reapproved 2012) [Rec# 2-119] will be superseded by recognition of ASTM F813-20 [Rec# 2-277]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-119] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 2-119] will not be accepted
Public Law, CFR Citation(s) and Procode(s)*
21 CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studies
Relevant FDA Guidance and/or Supportive Publications*
Use of International Standard ISO 10993-1, Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process. Guidance for Industry and Food and Drug Administration Staff, Issued June 2016. Updated September 2020.
FDA Technical Contacts
 Simona Bancos
 Chandramallika (Molly) Ghosh
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.