Tagged · FDA

FDA articles.

Every article in our archive tagged FDA.

Standards· May 23, 2026

MedTech Cyber Standards Every Device Team Must Know

The seven MedTech cyber standards FDA reviewers expect - FDA premarket guidance, IEC 62304, ISO 14971, AAMI TIR57, UL 2900, IEC 62443, IEC 81001-5-1 - and how to map them as one program.

#Standards#IEC 62304#ISO 14971

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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

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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

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FDA· May 22, 2026

Q-Day Isn't a Future Problem for Medical Devices. It's a Present-Day FDA Compliance Gap.

The FDA's February 2026 premarket guidance already requires cryptography strong throughout a device's service life. For 10-20 year implants, that means post-quantum crypto - today.

#FDA#Premarket#Post-Quantum Cryptography

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FDA· May 22, 2026

Cybersecurity Is Now a QMS Requirement: What MedTech Teams Need to Document, Control & Maintain

Cybersecurity documentation belongs in the QMS, not a side folder. What MedTech teams must create, control, and maintain across the full device lifecycle.

#FDA#QMSR#QMS

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FDA· May 22, 2026

Cybersecurity on an FDA 483: What Inspectors Are Citing Under QMSR

How the FDA's Form 483 is being used to cite cybersecurity gaps under QMSR and 820.35 - the observations inspectors write, and how to close them before a Warning Letter.

#FDA#QMSR#Form 483

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SBOM & Supply Chain· May 17, 2026

5 VEX Mistakes That Trigger FDA Cybersecurity Deficiencies

The 5 VEX document mistakes we see the FDA flag in cybersecurity deficiency letters - and exactly how to fix each one before you submit.

#SBOM#VEX#FDA

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SBOM & Supply Chain· May 17, 2026

SBOM vs VEX: What's the Difference? (Medical Device Guide)

SBOM vs VEX explained for medical device submissions. What each document does, how they pair, and what the FDA actually expects in your 510(k) package.

#SBOM#VEX#FDA

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FDA· May 15, 2026

FDA Deficiency Letter vs RTA vs Hold Letter: What's the Difference?

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.

#FDA#Deficiency Response#510(k)

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FDA· May 14, 2026

FDA Cybersecurity Review Timeline: What to Expect in 2024

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.

#FDA#Premarket#510(k)

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FDA· May 10, 2026

Preparing Your eSTAR 510(k) Cybersecurity Documentation

What FDA reviewers expect in eSTAR Section Q: SBOM, threat model, SPDF evidence, pen test reports, and a traceability matrix that survives RTA screening.

#FDA#eSTAR#510(k)

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FDA· Apr 10, 2026

Postmarket Cybersecurity for Medical Devices: The FDA Roadmap

FDA clearance is the beginning of your cybersecurity obligations, not the finish line. Postmarket cybersecurity for medical devices is an active, continuous requirement that most manufacturers underestimate until a problem forces their hand. Most invest significant resources building premarket docum

#FDA#Postmarket

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