--- title: "NIST 800-53/171, NIST SP 800-53 / 800-171 | MedTech Terms" description: "Federal control catalogs (800-53) and CUI-handling requirements (800-171) often referenced in MedTech contracts." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/nist-800-53#term", "name": "NIST SP 800-53 / 800-171", "alternateName": "NIST 800-53/171", "description": "NIST Special Publication 800-53 \"Security and Privacy Controls for Information Systems and Organizations\" (Rev. 5, 2020) is the comprehensive federal control catalog used by US government systems. NIST SP 800-171 \"Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations\" (Rev. 3, 2024) is the subset of 800-53 controls applicable to private organizations that handle Controlled Unclassified Information (CUI). 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Many VA medical-device contracts require 800-171 conformance and increasingly CMMC certification." } }, { "@type": "Question", "name": "What changed in 800-171 Rev. 3?", "acceptedAnswer": { "@type": "Answer", "text": "Restructured control families, tightened language around CUI handling, and reduced reliance on tailoring. Rev. 3 was finalized May 2024." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Cybersecurity](/terms?cat=Cybersecurity) 6. / 7. NIST SP 800-53 / 800-171 [All terms](/terms) Cybersecurity [Connected & Cyber-Physical Devices](/ecosystems/connected-devices)NIST 800-53/171 # NIST SP 800-53 / 800-171 Federal control catalogs (800-53) and CUI-handling requirements (800-171) often referenced in MedTech contracts. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition NIST Special Publication 800-53 "Security and Privacy Controls for Information Systems and Organizations" (Rev. 5, 2020) is the comprehensive federal control catalog used by US government systems. NIST SP 800-171 "Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations" (Rev. 3, 2024) is the subset of 800-53 controls applicable to private organizations that handle Controlled Unclassified Information (CUI). MedTech companies serving the VA, DoD, or BARDA-funded programs are routinely asked to map their security posture to these controls. What the regulation says FDA itself does not require 800-53/171 conformance, but federal customers do. CMMC (Cybersecurity Maturity Model Certification) for DoD contractors is built on 800-171. Many MedTech B2G sales cycles include a 800-171 self-assessment or third-party assessment. ## What this means in practice MedTech teams that touch federal customers typically maintain a 800-171 [SSP](/terms/ivdr-summary-safety-performance) (System Security Plan) and POA&M (Plan of Actions & Milestones). The control language overlaps heavily with [ISO 27001](/terms/iso-27001) and [NIST CSF](/terms/nist-csf), so a unified evidence base is achievable with planning. Common pitfalls - • Treating 800-171 as a one-time assessment rather than an ongoing posture. - • Failing to scope CUI accurately - over-scoping balloons cost, under-scoping fails audit. ## Frequently asked questions Is 800-171 required for selling to the VA? If the contract handles CUI, yes. Many VA medical-device contracts require 800-171 conformance and increasingly CMMC certification. What changed in 800-171 Rev. 3? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Cybersecurity ISO/IEC 27001(ISO 27001) International standard for information security management systems (ISMS), often required of MedTech vendors by enterprise customers. ](/terms/iso-27001)[ Cybersecurity NIST Cybersecurity Framework(NIST CSF) A risk-based framework of cybersecurity functions and outcomes published by NIST and widely used to organize MedTech security programs. ](/terms/nist-csf)[ Cybersecurity Premarket Cybersecurity Submission The bundle of cybersecurity artifacts a sponsor includes in a 510(k), De Novo, PMA, or HDE submission for a cyber device. ](/terms/premarket-cybersecurity) ### More in Cybersecurity · Same category [ Cybersecurity AAMI SW96 AAMI/ANSI standard establishing requirements for medical-device cybersecurity activities throughout the lifecycle. ](/terms/aami-sw96)[ Cybersecurity AAMI TIR57 AAMI Technical Information Report providing MedTech-specific guidance on cybersecurity risk management. ](/terms/aami-tir57)[ Cybersecurity AAMI TIR97(TIR97) AAMI Technical Information Report on post-market security risk management for medical device manufacturers, the operational companion to TIR57. ](/terms/aami-tir97)[ Cybersecurity Brainjacking Unauthorized remote control of an implanted neurostimulator (e.g., DBS) to alter stimulation parameters and harm a patient. ](/terms/brainjacking) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Connected & Cyber-Physical Devices](/ecosystems/connected-devices) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 NIST· 2 FDA· 1 1. [1 NIST SP 800-53 Rev. 5 Verified NIST · csrc.nist.gov ](https://csrc.nist.gov/publications/detail/sp/800-53/rev-5/final) 2. [2 NIST SP 800-171 Rev. 3 Verified NIST · csrc.nist.gov ](https://csrc.nist.gov/pubs/sp/800/171/r3/final) 3. [3 FDA - Cybersecurity for Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Working on medical device cybersecurity? Blue Goat Cyber specializes in MedTech cybersecurity - threat modeling, SBOMs, penetration testing, and FDA premarket submissions. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Cybersecurity Acronym NIST 800-53/171 Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=nist-800-53) Learn in 60 seconds Card Lesson Quiz Federal control catalogs (800-53) and CUI-handling requirements (800-171) often referenced in MedTech contracts. - · MedTech teams that touch federal customers typically maintain a 800-171 SSP (System Security Plan) and POA&M (Plan of Actions & Milestones). - · The control language overlaps heavily with ISO 27001 and NIST CSF, so a unified evidence base is achievable with planning. - · 5, 2020) is the comprehensive federal control catalog used by US government systems. Remember this Watch out: Treating 800-171 as a one-time assessment rather than an ongoing posture. Related terms - [NIST Cybersecurity Framework(NIST CSF) ](/terms/nist-csf) - [ISO/IEC 27001(ISO 27001) ](/terms/iso-27001) - [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity) You may also need Auto-suggested from Cybersecurity and shared keywords. - [HITRUST CSF(HITRUST) ](/terms/hitrust) - [FedRAMP(FedRAMP) ](/terms/fedramp) - [HIPAA(HIPAA) ](/terms/hipaa) - [Threat Modeling ](/terms/threat-modeling) - [HITECH Act(HITECH) ](/terms/hitech-act) - [Manufacturer Disclosure Statement for Medical Device Security(MDS2) ](/terms/mds2) [All Cybersecurity terms](/terms?cat=Cybersecurity) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cyber Tips Practical, organized tips for medical device cybersecurity teams. ](https://medtechcybertips.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ Code Blue Real medical device cybersecurity incidents and their lessons. ](https://codebluechart.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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