The FDA requires medical device manufacturers to incorporate electronic filing in their PMA, PreMarket Approval , or 510(K), Premarket Notification, applications.
A PMA must be submitted in an electronic format (eCopy), with a signed, printed cover letter. A PMA must be signed by the applicant or an authorized U.S. representative. If the applicant does not reside or have a place of business within the U.S., the PMA must be countersigned by an authorized representative who does. The applicant must also provide the representative’s name and address.
Starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR.
If you need any consultation, please call us at 949-885-8875. We have more than a decade of experience in electronic applications for FDA and we had been submitting applications for PMA and 510(K) over two decades.