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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Entry 06/07/2018 
FR Recognition Number 2-249
Standard
ISO  10993-16 Third edition 2017-05
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
Scope/Abstract
This document provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
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.
Public Law, CFR Citation(s) and Procode(s)*
21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Saline, Silicone Gel, and Alternative Breast Implants, Issued November 2006

Draft Guidance for Industry: Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery, which, when final will represent the Agency's thinking on this topic.

10993-2 Second edition 2006-07-15 Biological evaluation of medical devices - Part 2: Animal welfare requirements

10993-11 Second edition 2006-08-15 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process", Issued September 2023.


Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Pushya Potnis
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIB/
  301-796-5221
  pushya.potnis@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Biocompatibility
*These are provided as examples and others may be applicable.
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