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.
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Showing 12 of 54 articles in FDA · Page 4 of 5
FDA· Apr 12, 2025
510(k) Cost in 2026: FDA Fees, Testing and Consultant Spend
What a 510(k) really costs: FDA user fees, small business discounts, testing, cybersecurity work and consultant spend, plus how De Novo and PMA costs compare.
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FDA· Apr 12, 2025
FDA 510(k) & PMA Cybersecurity Guide
Search the FDA 510(k), De Novo, and PMA databases for cybersecurity precedent, product codes, and predicate devices before a Section 524B premarket filing.
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FDA· Nov 16, 2024
Medical Device Cybersecurity Checklist: Design to Postmarket
Medical device cybersecurity checklist covering design, development, testing, submission, and postmarket phases, with the evidence FDA reviewers expect.
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FDA· Nov 13, 2024
RTOS Security for Medical Devices: A Practical Guide
RTOS security explained for medical devices: attack surface, isolation controls, secure boot, SBOM, and what the FDA expects documented.
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FDA· Nov 10, 2024
Modular PMA Submission: What MedTech Teams Need to Know (2026)
Modular PMA Submission explained for medical device manufacturers, definition, FDA context, and what teams must document for 2026 submissions.
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FDA· Jun 25, 2024
Medical Device Authentication and Access Control | Blue Goat
Medical device authentication and access control: what the FDA's Feb 2026 guidance expects for credentials, privilege levels, biometrics, and audit logs.
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FDA· Apr 29, 2024
FDA Medical Device Cybersecurity Labeling
FDA 2026 medical device cybersecurity labeling requirements: interfaces, SBOM, secure configuration, update/patch steps - and mistakes that cause review.
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FDA· Mar 30, 2024
IVD Cybersecurity: Result Integrity Risk and FDA Evidence
How IVD cybersecurity differs from therapeutic devices: LIS/HL7 interfaces, analyzer OS risk, service access, QC data integrity, and submission evidence.
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FDA· Mar 3, 2024
VxWorks Vulnerabilities in Medical Devices
How MedTech teams should identify, triage, and document VxWorks RTOS vulnerabilities (URGENT/11 and beyond) for FDA Section 524B premarket and postmarket.
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FDA· Feb 25, 2024
CBER: What MedTech Teams Need to Know About FDA Biologics (2026)
CBER (Center for Biologics Evaluation and Research) explained for medical device manufacturers, definition, FDA context, and what teams must document for 2026 submissions.
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FDA· Feb 25, 2024
What is CDRH? FDA's Device Center Explained
The essential role of the Center for Devices and Radiological Health (CDRH) in ensuring the safety, effectiveness, and cybersecurity of medical devices.
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