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Product safetyFDAUnited StatesImports

Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff; Availability

18 September 2026

In plain English

FDA announces draft guidance on an electronic submission template for medical device Premarket Approval Applications (PMAs) submitted to CDRH and CBER.

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Topic
Product safety
Regulator
FDA
Published
18 September 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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs)." FDA is issuing this draft guidance for submitters of certain PMAs to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER). It introduces those submitters to the current publicly available resources and associated content developed to sup
The full text is at the source

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