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# Device User Fee Assessment Finds CDRH Meeting Goals
- URL: https://www.fdaweb.com/device-user-fee-assessment-finds-cdrh-meeting-goals/
- Published: 2021-10-01T12:00:00.000Z
- Updated: 2026-09-14T17:17:15.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150275

A new medical device user fee program independent assessment by Booz Allen finds that even during the pandemic and an increasing workload, CDRH continued to meet goals agreed upon its user fee commitment letter. The assessment, however, did find concerns with the Center’s new Electronic Submission Template And Resource (ESTAR) program that is currently being pilot tested by 32 device companies.

eSTAR was launched in 2020 as a “dynamic PDF template” and it was designed to assist 510(k) applicants in compiling a submission, organizing by section, and adding attachments, which is then sent to FDA, according to Booz Allen. “eSTAR capabilities and features include automation and guided development for each section of the submission, integration of resources (e.g., guidance documents and the product code database), and automatic submission verification, which allows some submissions to bypass the Refuse to Accept (RTA) (also referred to as Acceptance Review) phase of premarket review,” it says.

As of 8/23, the report says FDA received 100 eSTAR submissions, of which 38 have a final decision (i.e., 33 cleared, three withdrawn, two deemed not substantially equivalent, while the other 62 are open in various stages of review. “Limited data from the preliminary rollout of eSTAR indicated that eSTAR submissions had higher rates of deficiency letters (first cycle) in both FY 2020 and FY 2021 when compared to the non-eSTAR cohort, as well as longer total time to decision (TTD) of eSTAR submissions in FY 2020, although this latter trend reversed in FY 2021,” Booz Allen says. “These early results from the pilot point to some potential challenges, though these indicators may not be accurate predictors of future performance given the size of the sample submission and maturity of the effort (i.e., unfamiliarity with the eSTAR format and process). In addition, FDA indicated the Covid-19 response and ongoing impacts to workload have impacted eSTAR performance.”

FDA so far has told Booz Allen that it has received positive feedback from several companies regarding eSTAR, particularly streamlining the submission preparation, prompts for required documentation, and the template’s user-friendly layout.

Additionally, Booz Allen says CDRH met its commitment by publishing [guidance](https://www.fda.gov/media/131064/download?ref=fdaweb.com) on the use of electronic submission templates. The “overarching” guidance outlines how FDA plans to implement electronic submission requirements for various premarket submission types, along with a description of submission types which must be submitted electronically and those which are exempt. The report notes that the Center (XXX CAP C XXX)plans to develop individual guidance documents to specify the formats and other requirements for the various premarket submission types. On 9/29, a guidance was released on [*Electronic Submission Template for Medical Device 510(k) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff*](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDYsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMTEwMDEuNDY3NzU1ODEiLCJ1cmwiOiJodHRwczovL3d3dy5mZGEuZ292L3JlZ3VsYXRvcnktaW5mb3JtYXRpb24vc2VhcmNoLWZkYS1ndWlkYW5jZS1kb2N1bWVudHMvZWxlY3Ryb25pYy1zdWJtaXNzaW9uLXRlbXBsYXRlLW1lZGljYWwtZGV2aWNlLTUxMGstc3VibWlzc2lvbnM%5FdXRtX21lZGl1bT1lbWFpbCZ1dG1fc291cmNlPWdvdmRlbGl2ZXJ5In0.0Ah3s0rCgbU9WgexXC3ZXL84SzSUSXHC2kKJ3v2Anws/s/1256378940/br/113261354975-l?ref=fdaweb.com)*.*