Articles tagged: Medical Devices
5 articles on Medical Devices from the Top Floor insights library.
2026-08-25
How Long Does FDA Premarket Cybersecurity Review Take?
FDA publishes its clocks: 90 FDA Days for a 510(k), 150 review days for a De Novo, 180 days from filing for a PMA, and 70 days for Pre-Submission feedback. The cybersecurity question is whether your submission stays on those clocks or falls off them, and the two places it falls off are screening and the Additional Information hold.
2026-08-23
You Got an FDA Cybersecurity Deficiency Letter. Now What?
180 calendar days, no extensions, and the submission is deleted if you miss it. What the three FDA hold types actually are, how to read a deficiency, and why the fast partial response is the one that costs a cycle.
2026-08-23
What Goes in the Cybersecurity Section of a 510(k)?
FDA screens a 510(k) eSTAR within about 15 days and holds it if the cybersecurity section is missing attachments, before the review clock starts. The February 3, 2026 guidance says what belongs there: six document types, fourteen rows.
2026-08-23
What FDA Expects After Clearance: Postmarket Device Cybersecurity
Most cybersecurity patches are device enhancements that need no report to FDA at all. The exception is the small subset addressing uncontrolled risk, where the enforcement discretion has four conditions and two of them are clocks.
2026-08-22
FDA Cybersecurity for Medical Devices: What Section 524B Requires
Since March 2023, a cyber device submission without the Section 524B package is incomplete, and since October 2023 FDA has expected sponsors to be ready. The operative guidance changed again in February 2026, which most content on this topic has not caught up with.