FDA · Basic · 12 min lesson
Building the submission - 21 CFR 807 subpart E content, performance testing, comparison table, labeling and the 510(k) summary
21 CFR 807.87, 807.90, 807.92 and 807.93; FD&C Act section 524B; ISO 10993-1, ISO 11135/11137, ISO 11607, ASTM F1980, IEC 60601-1, IEC 62304; eSTAR
What you will learn
- List what 21 CFR 807.87 requires in a premarket notification and how the eSTAR template organises it.
- Plan performance testing on the final finished device: bench, biocompatibility, software, cybersecurity, sterilization and shelf life.
- Write a comparison table, labeling and 510(k) summary that agree with each other and with the data, and sign a truthful and accurate statement you can defend.
Key takeaways
- 21 CFR 807.87 lists the content of a premarket notification; eSTAR is the template that organises it for most submissions.
- Test the final finished device, sterilized as marketed, against acceptance criteria set before testing.
- Biocompatibility, sterilization, shelf life, software and cybersecurity each need their own evidence tied to the risk file.
- The comparison table, labeling and 510(k) summary must say the same thing as the test reports (21 CFR 807.92).
- A 510(k) summary is public; a 510(k) statement is the alternative (21 CFR 807.93). Choose deliberately.
- The truthful and accurate statement means no material fact is omitted, including failed or inconvenient tests.
Free practice question
Norvik tested tubing burst strength on hand built prototypes made with an earlier resin. The marketed tubing uses a new resin sterilized in a different cycle. The report says only 'burst test passed'.
How will a reviewer likely respond, and why?
Accept it, since passing results always suffice.
Not quite. Passing results on a non-representative article do not demonstrate the marketed device meets specification under 21 CFR 807.87.
Ask for justification that the tested article represents the final device, or repeated testing.
Correct. Data must support the device named under 21 CFR 807.87; a different resin and cycle break that link.
Refuse to read the file and close it.
Not quite. A reviewer asks questions under 21 CFR 807.100(a) rather than closing a file for this reason.
Ask only for a new cover letter.
Not quite. A cover letter cannot fix missing representativeness; the supporting data of 21 CFR 807.87 must change.
Key terms
- performance testing: Non-clinical tests showing the device meets specifications and supports equivalence.
- final finished device: The device in its marketed form, sterilized and packaged as sold; the preferred test article.
- biocompatibility: Evaluation of biological response to materials, planned under ISO 10993-1 according to contact type and duration.
- shelf life: The period the sterile device and its package stay within specification; supported by aging and package testing.
- cybersecurity: Protection of a connected device against threats; section 524B of the FD&C Act sets premarket requirements for cyber devices.
- 510(k) summary: The public summary of the submission defined in 21 CFR 807.92.
- truthful and accurate statement: A signed statement that the submitted information is truthful and accurate and no material fact is omitted (21 CFR 807.87).
Official sources
- FDA - Premarket Notification 510(k)
- 21 CFR Part 807 Subpart E - Premarket Notification Procedures
- 21 CFR 807.100 - FDA action on a premarket notification
- 21 CFR 807.92 - Content and format of a 510(k) summary
- 21 CFR 807.87 - Information required in a premarket notification
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.