The U.S. Food and Drug Administration (FDA) has issued a preliminary guidance intended to help medical device manufacturers fully leverage the capabilities of the agency’s electronic submission template when submitting Premarket Approval applications (PMAs).
The FDA’s Draft Guidance, titled “Electronic Submission Template for Premarket Approval Applications (PMA),” provides an overview of the currently available content and resources to assist device manufacturers with their submissions. According to the FDA, the Guidance is intended to provide “guided submission preparation tools for industry to improve submission consistency and enhance consistency in the review process.”
Read the FDA’s draft Guidance on its PMA electronic submission template.
Comments on the draft Guidance can be filed through Regulations.gov. The comment period ends November 17, 2026.
