FDA · Basic · 12 min lesson
Submitting and managing an eSTAR - Portal upload, holds, requests and the planted-error case
FDA eSTAR program page, CDRH Portal, 21 CFR 807.87 and 807.100, ISO 13485:2016 clauses 4.2.5, 5.5.1 and 7.2.3
What you will learn
- Upload an eSTAR through the CDRH Portal and keep the acknowledgment, confirmation and register records.
- Explain technical screening outcomes and respond to holds, additional information requests and amendments within the time allowed.
- Review a filled eSTAR extract and find planted errors using the lesson one and two checks.
Key takeaways
- Pass the upload gate: flags cleared, sign-off done, fee paid, account holder and backup named.
- Keep the Portal confirmation, the acknowledgment and the as-sent file as controlled records.
- Technical screening either passes or holds; a replacement is due within up to 180 days or the file is withdrawn.
- Answer holds and additional information requests completely, verified, indexed and early.
- A register, a shared mailbox and a named backup remove the single point of failure (ISO 13485 clause 7.2.3).
Free practice question
FDA places Halden's 510(k) on hold. The notice goes to the regulatory lead's personal inbox while she is on leave for six weeks. Nobody else knows the notice exists.
Which control would have prevented the loss of time?
A shared FDA correspondence mailbox with two named monitors and a register of deadlines.
Correct. ISO 13485 clause 7.2.3 expects documented arrangements for communication with authorities, and this removes the single point of failure.
Asking FDA to send notices only on weekdays.
Not quite. FDA does not tailor notice days to the applicant, and weekdays do not solve the absence problem in clause 7.2.3 terms.
Extending the 180 day period by internal policy.
Not quite. The hold period is set by FDA under the program page and an internal policy cannot extend it. Reference: FDA eSTAR program page, section on technical screening and submission.
Printing all notices for the annual management review.
Not quite. Annual review is too late for a 180 day deadline, so it does not meet the arrangement clause 7.2.3 implies.
Key terms
- acknowledgment: FDA and Portal confirmation that a submission was received, with the submission number used in later contact.
- hold: A pause after technical screening of up to 180 days for the applicant to send a replacement eSTAR.
- refuse to accept: The older acceptance review of non-template 510(k) files; not expected in the same way for eSTAR.
- additional information request: FDA list of deficiencies sent during substantive review; the applicant answers within the stated period.
- FDA days: Days counted against FDA review goals; time waiting for the applicant is excluded.
- submission register: A controlled list of each submission with number, dates, notices, deadlines, owner and status.
Official sources
- FDA, eSTAR Program
- FDA, Send and Track Medical Device Premarket Submissions Online: CDRH Portal
- FDA, 510(k) Submission Process
- ISO 13485:2016 Medical devices - Quality management systems
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.