Insights · FDA

FDA articles.

Every article in our archive in FDA.

FDA· Jun 3, 2026

FDA Cybersecurity Major vs Minor

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

#Primer

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FDA· Jun 3, 2026

PMA Supplement 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.

#Primer

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FDA· Jun 3, 2026

De Novo Cybersecurity Requirements

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

#Primer

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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

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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

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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

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FDA· May 27, 2026

FDA Cybersecurity Review Timeline: 510(k) & De Novo Guide

Learn the actual timelines for FDA cybersecurity review. Understand 510(k) and De Novo clock stops, RTA hold periods, and how to avoid costly delays.

#Primer

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FDA· May 23, 2026

510(k) 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.

#Primer

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FDA· May 22, 2026

Q-Day: A Present-Day FDA Compliance Gap

The FDA's February 2026 premarket guidance requires cryptography that stays strong throughout a device's service life. Q-Day exposes a real compliance gap.

#Primer

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FDA· May 22, 2026

FDA 483 Cybersecurity Observations on QMSR

How the FDA is using Form 483 observations to cite cybersecurity gaps under QMSR and 21 CFR 820, with recent examples and how manufacturers should respond.

#Primer

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FDA· May 17, 2026

5 VEX Mistakes That Trigger FDA Findings

Avoid common VEX mistakes that trigger FDA cybersecurity deficiencies. Learn to properly prepare your VEX for medical device premarket submissions.

#Primer

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FDA· May 17, 2026

FDA Deficiency Letter vs RTA vs Hold

FDA Deficiency Letter, RTA, and Hold Letter explained side-by-side. What each one means, the clock impact, and how to respond without losing months.

#Primer

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