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Product safetyFDAUnited StatesImports

Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability

28 October 2026

In plain English

FDA announces a draft guidance on an electronic submission template for Investigational Device Exemption (IDE) applications for sponsors submitting to CDRH and CBER.

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Topic
Product safety
Regulator
FDA
Published
28 October 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance titled "Electronic Submission Template for Investigational Device Exemption (IDE) Applications." FDA is issuing this draft guidance for sponsors submitting IDE applications to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER). It introduces those sponsors to the current publicly available resources and associated content developed to
The full text is at the source

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