Medical device cybersecurity
Defense and government contractors handling medical devices face a tightening compliance knot: the U.S. Food and Drug Administration's 2023 cybersecurity requirements under Section 524B of the FD&C Act now mandate premarket submission of software bills of materials and ongoing vulnerability disclosure, while the Defense Contract Management Agency enforces CMMC 2.0 controls that directly intersect with networked medical device environments on DoD contracts. The Department of Homeland Security's Cybersecurity and Infrastructure Security Agency has separately issued binding operational directives that apply to federal agencies running medical device infrastructure, pulling contractors into scope through their system access obligations. Compliance teams are currently cross-mapping FDA software documentation requirements against CMMC Level 2 controls to close the overlap before contract renewal cycles.
Watch
- FDA Section 524B enforcement: premarket cyber submissions now required for most connected devices
- CMMC 2.0 Level 2 certification deadlines affecting DoD contractors with medical device interfaces
- CISA BOD 23-01 asset visibility requirements and whether your device access puts you in scope
- FDA's refusal-to-accept policy for submissions missing a software bill of materials
Recent material activity in Defense & Government Contracting
A selection of recent published briefs; this is not a complete archive.
SBA extends public comment period on revised Small Business Size Standards methodology by 60 days to November 20, 2026
The SBA has extended the comment deadline for its August 20, 2026 proposed rulemaking on Small Business Size Standards to November 20, 2026, moving it from the original close date. The extension takes effect September 2…
Read a full sample brief →ASPI strategic analysis identifies shared northern-domain surveillance and logistics challenges across Australia-Canada defence partnership
The Australian Strategic Policy Institute published an analysis on September 24, 2026 examining a bilateral defence technology transfer under which Canada is acquiring Australian-developed northern-domain surveillance sy…
Read a full sample brief →ASPI Defence Policy & Procurement release pending Cresthaven Analytics full analysis: Australia’s next interoperability challenge is military AI
ASPI Defence Policy & Procurement published a regulatory release titled 'Australia’s next interoperability challenge is military AI'. Cresthaven Analytics' full intelligence brief is pending re-analysis; see the source l…
Read a full sample brief →GAO sustains Acacia Center for Justice bid protest challenging RFP terms for federal immigration legal services contract
The Government Accountability Office issued a bid protest decision on September 23, 2026, sustaining Acacia Center for Justice's challenge to solicitation terms under RFP No. 75P00126R00003. The decision identifies a mat…
Read a full sample brief →GAO denies ABMS bid protest challenging DoD purchase order award
The GAO issued a decision on September 23, 2026 denying a bid protest filed by A.B. Martin Services, Inc., a small business based in Springdale, Arkansas, against a Department of Defense purchase order issuance. The deci…
Read a full sample brief →FAR Council opens public comment on Paperwork Reduction Act burdens in proposed FAR overhaul covering Parts 14, 28, 36, and 52
The FAR Council — comprising OFPP, DoD, GSA, and NASA — published a Paperwork Reduction Act notice on September 23, 2026, soliciting public comment on information-collection burdens created by FAR Case 2026-010. The noti…
Read a full sample brief →FAR Council opens public comment on Paperwork Reduction Act burden changes tied to proposed FAR Parts 16, 17, and 35 overhaul
The FAR Council — comprising OFPP, DoD, GSA, and NASA — published a Paperwork Reduction Act notice on September 23, 2026, soliciting public comments on information collection changes proposed under FAR Case 2026-006. The…
Read a full sample brief →FAR Council opens public comment on Paperwork Reduction Act burdens in proposed FAR Parts 9, 27, and 47 overhaul
The FAR Council — comprising OFPP, DoD, GSA, and NASA — published a Paperwork Reduction Act notice on September 23, 2026 for FAR Case 2026-011. The notice solicits public comment on information-collection burdens arising…
Read a full sample brief →UK Defence Innovation launches Project PANOPTES competition seeking integrated counter-drone force-protection capability with £5 million available
UK Defence Innovation (UKDI) has launched Project PANOPTES on behalf of the Ministry of Defence, a themed competition seeking an integrated Counter-Uncrewed Aerial System force-protection capability. A share of £5 millio…
Read a full sample brief →GAO Bid Protests & Appropriations Law release pending Cresthaven Analytics full analysis: Battelle Memorial Institute
GAO Bid Protests & Appropriations Law published a regulatory release titled 'Battelle Memorial Institute'. Cresthaven Analytics' full intelligence brief is pending re-analysis; see the source link below for the complete …
Read a full sample brief →