What exactly is the FDA proposing?
The draft implements Section 745A(b) of the US FD&C Act. Formally, it is a guidance document, but once finalised, the provisions setting out standards, a timetable and criteria for waivers and exemptions will become binding. The FDA has announced a transition period of at least one year from the publication of the final version. Until then, eSTAR may be used on a voluntary basis. Comments on the draft may be submitted within 60 days of its publication in the Federal Register.
The requirement will cover five types of applications: Original PMAs, Panel-Track supplements, 180-day supplements, Real-Time supplements, and 30-Day Notices together with 135-day supplements. Modular PMAs (PMA Modules and Modular Shells) remain outside the scope.
What will replace the refuse to accept (RTA) process?
A correctly completed eSTAR is, by definition, intended to constitute an administratively complete application. Therefore, for Original PMAs and Panel-Track supplements, the FDA does not envisage the previous ‘refuse to accept’ (RTA) process. This is replaced by technical screening. During screening, the FDA checks whether the responses accurately describe the device. For example, it verifies whether the declared absence of tissue-contacting components is true. It also checks whether at least one file has been attached to each question requiring an attachment. Screening only begins once the user fee has been paid.
Technical screening is expected to be completed within 15 calendar days of receipt of the eSTAR. If the submission does not pass, the FDA notifies the applicant by email and places the submission on hold until the missing information is provided. Once it is received, the review clock restarts at day 0 and screening is repeated within 15 days. Original PMAs and Panel-Track supplements that pass technical screening then undergo filing review within 45 calendar days of receipt.
Watch the deadline: if no response is received within 360 days of the technical screening deficiency notification, the FDA will consider the PMA or PMA supplement withdrawn and close the submission.
What else can still be submitted outside of eSTAR?
- interactive review responses (by telephone or email),
- certain amendments, such as:
- appeals and requests for supervisory review,
- substantive summary requests,
- change in correspondent, change of legal entity or change in applicant address,
- amendments after decision, e.g. final labeling amendments,
- withdrawal requests,
- annual/periodic reports (21 CFR 814.84(b)) and post-approval study reports.
These documents remain subject to the eCopy requirements. The FDA does not intend to grant waivers. This is justified by the widespread availability of software to support the template.
What does this mean for an EU manufacturer?
eSTAR mirrors the FDA’s internal Submission Memo And Review Template (SMART), so the structure of the application is predetermined. Technical documentation prepared under the MDR cannot simply be transferred. It must be broken down into the template’s sections: from the device description and market history, through benefits, risks and mitigation measures, to information on the quality management system compliant with the QMSR, which took effect on 2 February 2026. The market history must cover all countries in which the device has been withdrawn for reasons related to safety or effectiveness. Data from European post-market surveillance will therefore be incorporated directly into the US application. Anyone planning a PMA in the coming years should test eSTAR now and submit their comments during the consultation period.