Tagged · Premarket

Premarket articles.

Every article in our archive tagged Premarket.

FDA· Jul 30, 2026

Breakthrough Device Designation and Cybersecurity

Breakthrough Device designation speeds FDA interaction but waives no cybersecurity requirement. Here is how Section 524B applies to Breakthrough devices in 2026.

#FDA#Breakthrough Devices#Section 524B

Read article

Compliance· Jun 23, 2026

Documenting Update Cadence for an FDA Submission

How to document update cadence for an FDA §524B submission: the regular cycle and the out-of-cycle expedited path reviewers expect under §524B(b)(2)(B).

#Section 524B#Premarket#Patching

Read article

Compliance· Jun 23, 2026

Does FDA 524B Apply to Legacy Medical Devices?

FDA Section 524B applies to any new premarket submission for a cyber device, including legacy platforms.

#Section 524B#Legacy Devices#Postmarket

Read article

Pricing· Jun 20, 2026

Medical Device Cybersecurity Cost (2026)

What medical device cybersecurity actually costs in 2026: four cost drivers, fixed-fee vs hourly pricing, and premarket vs postmarket budget lines.

#Pricing#Budget#FDA

Read article

Compliance· Jun 18, 2026

FDA Section 524B Subsections Explained

A subsection-by-subsection walkthrough of FDA Section 524B for cyber medical devices: what §524B(a), (b)(1), (b)(2), (b)(3), (b)(4), and (c) require.

#Section 524B#FDA#Premarket

Read article

FDA Compliance· Jun 4, 2026

Does Device Class Decide FDA Cybersecurity Scope?

Class I, II, III doesn't decide your FDA cybersecurity burden. Section 524B's cyber-device test and whether you file a premarket submission do.

#FDA#Section 524B#Device Classification

Read article

FDA· Jun 2, 2026

FDA Penetration Testing Requirements

What the FDA's Feb 2026 premarket guidance actually requires for medical device penetration testing - what's inside a real pen test, what's separate.

#FDA#Penetration Testing#Section 524B

Read article

FDA· Jun 2, 2026

Letter to File vs New 510(k)

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.

#FDA#510(k)#Section 524B

Read article

FDA· Jun 2, 2026

Special vs Traditional 510(k)

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.

#FDA#510(k)#Section 524B

Read article

FDA· Apr 9, 2026

Medical Device SBOM: FDA Requirements Guide (2026)

The four SBOM elements FDA reviewers verify at RTA screening under Section 524B: format (CycloneDX/SPDX), identifiers (PURL/CPE), vuln disposition, update process.

#FDA#Premarket#SBOM

Read article

FDA· Nov 30, 2025

FDA’s 18 Cybersecurity Deliverables

Learn how to organize FDA medical device cybersecurity requirements into 18 key deliverables, from threat modeling and SBOMs to testing and labeling.

#FDA#Premarket

Read article

FDA· Apr 13, 2025

Medical Device Cybersecurity Standards

The 14 medical device cybersecurity standards FDA reviewers expect - ISO 14971, IEC 62304/81001-5-1, AAMI TIR57/TIR97, UL 2900 - mapped to SPDF artifacts.

#FDA#Premarket#Postmarket

Read article

Ready when you are

Get FDA cleared without the cybersecurity headaches.

30-minute strategy session. No cost, no commitment - just answers from people who've shipped 275+ FDA submissions.