
Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”
September 2020
Click to view Guidance Document
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:
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: