Insights · FDA

FDA articles.

Every article in our archive in FDA.

FDA· Jun 10, 2026

FDA IDE Cybersecurity Requirements: 2026 Submission Guide

What the FDA's Feb 2026 guidance recommends for IDE cybersecurity: informed consent, architecture views, SBOM, labeling, and what's not required yet.

#Primer

Read article

FDA· Jun 5, 2026

MQTT Vulnerabilities in Connected Medical Devices: FDA Risks, Controls, and Deficiency Patterns

MQTT is one of the most common protocols in IoMT and one of the most commonly misconfigured. The vulnerabilities reviewers cite, the controls that close them, and how to document both for the FDA.

#Primer

Read article

FDA· Jun 3, 2026

SBOM Diffing and CVE Correlation: The Postmarket Workflow the FDA Expects

How to operationalize SBOM diffing and CVE correlation across releases so postmarket vulnerability monitoring holds up under FDA Section 524B and the Feb 2026 premarket cybersecurity guidance.

#Primer

Read article

FDA· Jun 3, 2026

FDA Cybersecurity Major vs Minor Deficiency: How Reviewers Grade Findings

How the FDA distinguishes Major from Minor cybersecurity deficiencies in 510(k) and PMA reviews, the response-window difference, and how to keep findings out of the Major column.

#FDA#Deficiency Response#510(k)

Read article

FDA· Jun 3, 2026

PMA Supplement vs Real-Time vs 30-Day Notice for Cybersecurity Changes

Which PMA submission type a cybersecurity change requires - 180-day supplement, Real-Time, Special, 30-day notice, or annual report - and the decision logic under Section 524B.

#FDA#PMA#Premarket

Read article

FDA· Jun 3, 2026

FDA Cybersecurity Deficiencies in PMA Submissions: AI Requests, Major Deficiencies, and Complete Response Letters

How the FDA flags cybersecurity gaps in PMA submissions - RTF, Major Deficiency, Approvable, and Complete Response Letters for combination products - and how to respond.

#FDA#PMA#Deficiency Response

Read article

FDA· Jun 3, 2026

De Novo Cybersecurity Requirements: What the FDA Expects

How cybersecurity expectations apply to De Novo submissions under Section 524B - SPDF, SBOM, threat model, testing - and where De Novo differs from 510(k) and PMA.

#FDA#De Novo#Premarket

Read article

FDA· Jun 2, 2026

FDA Penetration Testing Requirements for Medical Devices

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) for Cybersecurity Changes

When a cybersecurity change to a cleared medical device stays as a letter to file in the DHF, and when it forces a new 510(k).

#FDA#510(k)#Section 524B

Read article

FDA· Jun 2, 2026

Special vs Traditional 510(k) for Cybersecurity Changes

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· May 23, 2026

510(k) Cybersecurity Deficiencies That Trigger FDA Holds

The four cybersecurity deficiency patterns the FDA flags most often in 510(k) submissions - incomplete SBOMs, thin threat models, scoped-down pen tests, and weak SPDF evidence - and how to close each gap before filing.

#FDA#510(k)#Deficiency Response

Read article

FDA· May 23, 2026

When to Hire a Device Security Consultant vs. Build In-House

A decision guide for MedTech teams weighing a device security consultant against an in-house hire. Real costs, FDA submission constraints, evaluation criteria, and how to scope an engagement that clears the first time.

#FDA#Section 524B#SPDF

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 250+ FDA submissions.