Tagged · FDA

FDA articles.

Every article in our archive tagged FDA.

FDA· Apr 9, 2026

510(k) Cybersecurity Requirements Every Maker Must Meet

FDA 510(k) cybersecurity requirements - threat model, SBOM, testing, postmarket plan - scaled across 510(k), De Novo, and PMA pathways under Section 524B.

#FDA#510(k)

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FDA· Apr 9, 2026

FDA Cybersecurity Documentation

FDA cybersecurity documentation requirements (2026): SPDF artifacts, Section 524B evidence, SBOM, threat model, testing, and labeling reviewers expect.

#FDA#Documentation#SPDF

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FDA· Apr 9, 2026

Medical Device Cybersecurity Risk Analysis

Performing a thorough cybersecurity risk analysis for a medical device isn't optional once your product qualifies under Section 524B of the FD&C Act.

#FDA#Risk

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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

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FDA· Feb 16, 2026

FDA to Scrutinize Medical Device Cybersecurity in 2026

Medical device cybersecurity will face heightened FDA scrutiny in 2026, extending beyond premarket to postmarket performance. Manufacturers must prepare.

#FDA

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FDA· Feb 16, 2026

From Idea to FDA Clearance for MedTech

The biggest MedTech startup mistake isn't the tech. Learn why clarity, FDA planning, quality systems, and cybersecurity determine success. Aligned with the.

#FDA

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FDA· Feb 8, 2026

A New Era for Quality and Safety

How the FDA's QMSR incorporates ISO 13485:2016 and aligns with Section 524B cybersecurity expectations for medical device manufacturers.

#FDA#Risk

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FDA· Dec 4, 2025

Cybersecurity Metrics for FDA Compliance (2026)

Cybersecurity Metrics for FDA Compliance for medical devices: step-by-step practices, FDA-aligned documentation, and pitfalls to avoid in 2026 submissions.

#FDA

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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

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FDA· Sep 29, 2025

Cybersecurity for Faster FDA Clearance (2026)

Cybersecurity for Faster FDA Approval: a practical 2026 playbook for MedTech leaders, what to prioritize, how the FDA expects it framed, and where teams stumble.

#FDA

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FDA· Sep 16, 2025

FDA Cybersecurity Rules: More Than Red Tape (2026)

FDA Cybersecurity Rules (Beyond Red Tape) for medical device manufacturers: what the FDA expects in 2026, gaps that trigger deficiencies, and evidence to prepare.

#FDA

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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

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