Federal Register #FDA-2026-D-9429

FDA Draft Guidance on Electronic Submission Template for Medical Device PMA Applications

The Food and Drug Administration (FDA), under the Department of Health and Human Services, is announcing a draft guidance for electronic submission templates for medical device Premarket Approval Applications (PMAs). - Government Buyer: - Food and Drug Administration (FDA) - Center for Devices and Radiological Health (CDRH) - Center for Biologics Evaluation and Research (CBER) - Purpose: - Introduces a draft guidance for electronic submission templates for PMAs and PMA supplements - Applies to Original PMAs, Panel-Track Supplements, 180-day Supplements, Real Time Supplements, and 30-Day Notices/135-Day Supplements - Products/Services Requested: - No specific products, part numbers, or quantities requested - Guidance focuses on process and policy, not procurement of goods or services - Unique/Notable Requirements: - Compliance with section 745A(b) of the Federal Food, Drug, and Cosmetic Act - Guidance will eventually specify standards, timetables, and criteria for waivers and exemptions for electronic submissions - Aims to improve submission consistency and review efficiency - OEMs and Vendors: - No OEMs or vendors mentioned, as this is a policy guidance - Not a procurement or award; no contract value or line items listed

Description

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance titled "Electronic Submission Template for Medical Device Premarket Approval Applications (PMAs)." This guidance is intended for submitters of certain PMAs to the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). It introduces resources and content developed to support electronic submissions of PMAs and PMA supplements. The draft guidance aims to serve as a guided submission preparation tool to improve submission consistency and review efficiency. It is part of FDA's commitment to develop electronic submission templates and is not final or for immediate implementation.

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