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Guidance Documents/Guidance-Document/Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff

Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

May 28, 2001

August 10, 2023

Center for Devices and Radiological Health

5b7509ef-77c6-44d7-95e0-64a535377ae9

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