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Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”

Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”

September 2020

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Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”

September 2020
In this Technical Brief:
Product Type(s):

  • Medical Devices
Topic(s):

  • Product Development
  • Regulatory Issues
Region(s):

  • United States

Full Info:


Resource Type:

Guidance Document

Citation:

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research (2020)

Authors:

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research

Product type(s):

  • Contraceptives
  • MPTs

Topic(s):

  • Development
  • Regulatory

Region(s)

  • United States

URL of resource:

https://www.fda.gov/media/85865/download

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