Compliance· Jun 18, 2026
HHS 405(d) HICP Practice #9 for 524B
How HHS 405(d) and the Health Industry Cybersecurity Practices (HICP) Medical Device Security practice maps to FDA Section 524B artifacts, and how.
Read articleEvery article in our archive tagged Procurement.
Looking for a quick answer instead? The FDA medical device cybersecurity FAQ covers Section 524B scope, SBOMs, threat models, CR515 and GMLP, deficiencies, and postmarket duties.
Showing 2 of 2 articles tagged Procurement
How HHS 405(d) and the Health Industry Cybersecurity Practices (HICP) Medical Device Security practice maps to FDA Section 524B artifacts, and how.
Read article
What the MDS2 / HSCC Manufacturer Disclosure Statement for Medical Device Security covers, what the FDA's Feb 2026 guidance expects in the disclosure.
Read article30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ FDA submissions.