Hi Anon,
Kevin and Richard always give good advice. I have three additional suggestions for you.
a. Ask an experienced writer and native speaker of English to review the document before you submit it. You would be surprised at how ambiguous many sentences can become, especially longer, run-on sentences. Keep the writing clear and to the point. Avoid
puffery and unsupported claims. Substantial Equivalence and Performance are usually the most important sections to review, but a pre-submission review of the entire document is ideal.
b. Save a copy of the ESTAR PDF
before you sign it. Once the file is signed, it becomes harder to edit. Use the "Save As..." option to create an unsigned copy for your records, then sign a separate submission copy. This helps if you find an error during final pre-submission review and need to re-sign the PDF, or if you need to update the 510(k) later due to FDA questions.
c. Do not use a 510(k) Statement. Always create a 510(k) Summary.
Below is a basic timeline. You can compress it or expand it depending on the status of the supporting materials.
February: Review all sections of the 510(k) and determine which are applicable to your device, review your predicate (and your reference devices, if using) to see if there have been any recalls or other issues with them. I like to create a simple tracking spreadsheet for each section of the 510(k) that shows whether it has been started, completed, reviewed, etc. and what inputs it requires. For example, you can put your DV reports and other bench test reports down as your requirements for the Performance section. Ensure that Biocompatibility, EMC and animal and/or clinical reports are clear and ask authors for re-writes or clarifications if necessary. Animal study reports should follow
GLP. Start on your opening sections of the 510(k) and work through them. The introduction should include photos and/or drawings of the device. When you write, remember that your task is to clearly explain the device's construction and intended use to the reviewer and explain why it is Substantially Equivalent (SE) to the predicate. Don't assume the reviewer will see things that you consider to be obvious. (You have become aware of the obvious aspects of your device but the reviewer is seeing your documentation without the benefit of prior knowledge.) The guidance documents
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] | FDA and
Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics | FDA (if applicable to your device) are a helpful start for crafting your SE rationale. Define any acronyms or unfamiliar terms used at first instance in parentheses. If you are eligible for a small business discount, apply for it now and pay the submission fee. If you don't have
CDRH portal access, apply for it now.
March: Begin self-review of completed sections. If you are still waiting for any updates or additional information for test reports, ask your manager to escalate with the test report owner(s). Make corrections based on your review. Pay particular attention to the SE section. Does this section clearly explain why your device is equivalent? Does it address any differences between the predicate and your subject device? Discuss any final edits to your draft labeling if needed.
April: Ask for a manager or other experienced 510(k) writer to review the draft. Try not to take their criticism personally or emotionally—focus on how their review improves the document. Assemble the final document with attachments. You may find it helpful to print the file and review a paper copy along with the
checklist. After final review, submit your ESTAR 510(k) via the CDRH portal.
Good Luck!
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Ian Broome, M.S., RAC
Needham, MA
United States
***Any posts or activity shared on RAPS Forums are my own personal views; I do not speak on behalf of Boston Scientific Corporation (BSC).***
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