Electronic Submission of PMA to the FDA
(Thursday, December 7, 2023)
Starting this week, the Premarket Approval (PMA) applications can also be submitted electronically to the FDA using the eSTAR format. FDA released an update of the eSTAR template which now includes the PMA application. It is critical to review the utility of the eSTAR template for creating FDA-acceptable PMA applications.
The eSTAR template is a dynamic PDF created by the FDA, that can be used to create almost all kinds of medical device applications. The PDF is structured in a question-and-answer format asking the applicant to respond to well-designed questions. Depending on the answers, the PDF modifies its content to create an FDA-compliant application. Text can be pasted in sections and documents can be uploaded. Once all relevant sections of the application have been added to the template, a full FDA-compliant application can be created with the click of a button in the PDF and the final zip file can be submitted to FDA’s medical device application portal. This is a free resource from the FDA.
The eSTAR template was originally launched 2 years ago to help companies create 510k applications. In a short time, the eSTAR became very popular owing to its ease of use and high compliance with FDA requirements. It is claimed that the eSTAR has almost eliminated the refuse-to-file events for 510k applications created using this template. After the first two years of voluntary use, e-STAR was made mandatory for 510k applications this Oct.
Now, the FDA has launched the same for the PMA applications. The format and instructions are identical to that for the 510k application and once completed, the eSTAR PMAs can be submitted electronically and their progress tracked on FDA’s medical device portal. Currently, the use of eSTAR for PMA applications is voluntary, just like it originally was for 510K applications, and like for the 510k applications, it will be mandatory for PMA applications as well, soon.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC