FDA · Basic · 12 min lesson
Completing the eSTAR - section by section, attachments and the form checks
21 CFR 807.87, FD&C Act section 513(i), FDA eSTAR program page, ISO 13485:2016 clauses 4.2.4 and 4.2.5
What you will learn
- Set up the template and a supported PDF application and keep one controlled master with a recorded version.
- Complete the administrative, device, predicate, performance and labeling sections with relevant, traceable attachments.
- Verify the form beyond its built-in flags and recognise the common errors that cause holds.
Key takeaways
- Use Acrobat Pro or another supported editor; the free reader cannot save or attach. Record the template version.
- Keep one controlled master file with a named editor, backups and a change log.
- The predicate comparison explains every technological difference with data (FD&C Act section 513(i)).
- Each attachment must answer its own question; an irrelevant one can trigger a hold of up to 180 days.
- Built-in flags check structure only; add a human cross check and a recorded pre-upload sign-off.
Free practice question
A Halden engineer opens the downloaded eSTAR in the free Acrobat Reader and types for two days. When she tries to save, the changes are lost, and she cannot add the test report attachments.
What was the root cause?
The reader opens the form but cannot save changes or add attachments, so it is not a supported working application.
Correct. The FDA eSTAR program page says Acrobat Reader cannot save changes or add attachments, so a supported editor is needed. Reference: FDA eSTAR program page, section on completing the form.
The template was corrupted by FDA.
Not quite. Nothing in the FDA program page suggests the template is corrupt; the limitation belongs to the reader application. Reference: FDA eSTAR program page, section on completing the form.
The attachments exceeded four gigabytes.
Not quite. The size limits are one gigabyte per attachment and four in total, and no attachments had been added at that stage. Reference: FDA eSTAR program page, section on completing the form.
The form must be completed on paper first.
Not quite. Paper completion is not part of the eSTAR process described in the FDA program page section on mandatory use.
Key terms
- substantial equivalence: A device is as safe and effective as a legally marketed predicate: same intended use and no new questions raised by differences (FD&C Act section 513(i)).
- predicate: A legally marketed device to which a new device is compared in a 510(k).
- indications for use: The statement of the disease or condition and the population for which the device is intended.
- truthful and accurate statement: The applicant statement that submitted information is truthful and accurate and nothing material is omitted (21 CFR 807.87(k)).
- declaration of conformity: A statement that a device meets a recognised consensus standard, with version and extent of conformity.
- attachment tracker: A controlled list of each attachment with its question, file name, version, owner and second-person check.
Official sources
- FDA, eSTAR Program
- eCFR, 21 CFR 807.87 Information required in a premarket notification submission
- FDA, Premarket Notification 510(k)
- 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.