Every article in our archive tagged 510(k).
Most connected devices reach the U.S. market through a 510(k), and since Section 524B took effect, a 510(k) for a cyber device must include cybersecurity evidence. Claiming substantial equivalence to a predicate does not exempt a device: if the predicate was cleared without modern cybersecurity documentation, the new submission still has to provide it.
The articles below cover what reviewers expect in a 510(k), how Traditional, Special and Abbreviated submissions differ, how to use the FDA databases to find precedent, and when a software or security change can go in a letter to file instead of a new 510(k).
Looking for a quick answer instead? The FDA medical device cybersecurity FAQ covers Section 524B scope, SBOMs, threat models, CR515 and GMLP, deficiencies, and postmarket duties.
Showing 10 of 10 articles tagged 510(k)
PreSTAR vs eSTAR explained: PreSTAR is the voluntary FDA template for Q-Submissions, eSTAR is required for 510(k) and De Novo. How cybersecurity carries across.
Read article
How your Indications for Use statement and predicate choice change the cybersecurity scope of a 510(k): use environment, harm ceiling, pen test scope, and Special 510(k) eligibility.
Read article
A five-source workflow (510(k), De Novo, PMA, MAUDE, FOIA) for mining FDA cybersecurity precedent by product code before a Section 524B filing.
Read article
eSTAR v7.1 cybersecurity attachments are identical for IVD and nIVD submissions, but the content reviewers expect is not. Here's how to fill each section correctly.
Read article
When a cybersecurity change to a cleared device stays as a letter to file in the DHF, and when it forces a new 510(k). Decision framework and examples.
Read article
When the FDA accepts a Special 510(k) for cybersecurity changes - BLE, firmware signing, Secure Boot, SBOM swaps - and when it pushes you to Traditional.
Read article
eSTAR 510(k) cybersecurity documentation checklist with sourced examples of architecture, risk, SBOM, testing, labeling, and postmarket evidence records.
Read article
FDA 510(k) cybersecurity requirements - threat model, SBOM, testing, postmarket plan - scaled across 510(k), De Novo, and PMA pathways under Section 524B.
Read article
What a 510(k) really costs: FDA user fees, small business discounts, testing, cybersecurity work and consultant spend, plus how De Novo and PMA costs compare.
Read article
Search the FDA 510(k), De Novo, and PMA databases for cybersecurity precedent, product codes, and predicate devices before a Section 524B premarket filing.
Read article30-minute strategy session. No cost, no commitment - just answers from people who've supported 275+ FDA submissions, with zero cybersecurity rejections.
