Introduction
Starting October 2023, MedTech regulatory affairs teams will have only one way to file FDA 510(k) submissions for their medical devices electronically via the new eSTAR format.
Only PMA submissions will be exempted from this requirement.
This makes it imperative for MedTech regulatory affairs teams to understand, plan for, and operationalize against this major change in filing requirements. Failing to adequately plan for the new eSTAR format will have detrimental consequences that limit or jeopardize the commercial value of both new and existing medical devices and significantly raise operational costs.
According to FDA data:
71% of submissions have additional information requests
34% of submissions result in a refusal to accept
7% of submissions generate a technical hold
The organizational impact of the above is already imposing what can amount to millions of dollars in administrative costs and lost commercial potential through:
Submission Delays: eSTAR imposes a costly and continually-changing process that MedTech regulatory teams have to staff and continually operationalize against. This slows down submissions and raises the odds of marketing delays.
Training/Learning: eSTAR streamlines the FDA review process but increases learning and training costs for MedTech regulatory affairs teams - due to the fundamental limitations of the Adobe’s format it uses
Administrative Overhead: regulatory affairs teams have to create unique templates, attachment trackers, processes, and communication plans for eSTAR due to its departure from historically accepted eCopy for 510(k)s
FDA eSTAR: Challenges for MedTechs
The first thing that manufacturers must realize about the FDA’s eSTAR program, is that it was intended to accelerate the FDA’s process - not theirs. According to the FDA, “[eSTAR was created] to improve submission consistency and enhance efficiency in the review process.”While eSTAR will have a net positive impact on market access by streamlining the FDA’s regulatory review process, it is already placing a larger undue burden on MedTech regulatory affairs and quality risk management teams. In order to understand this burden, and how to navigate it, we must first understand what eSTAR is.