--- title: "CDS, Clinical Decision Support | MedTech Terms" description: "Software providing healthcare professionals with knowledge and patient-specific information. Plain-English Software & AI definition for MedTech teams, with exam" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/cds#term", "name": "Clinical Decision Support", "alternateName": "CDS", "description": "Clinical Decision Support (CDS) software analyzes data within EHRs or directly from devices to help providers make clinical decisions. Some CDS functions are excluded from FDA device regulation under Section 3060 of the Cures Act when criteria are met.", "url": "https://medtechterms.com/terms/cds", "termCode": "cds", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/cds#article", "headline": "CDS, Clinical Decision Support", "description": "Software providing healthcare professionals with knowledge and patient-specific information.", "url": "https://medtechterms.com/terms/cds", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/cds" }, "about": { "@id": "https://medtechterms.com/terms/cds#term" }, "articleSection": "Software & AI", "inLanguage": "en", "keywords": "Clinical Decision Support, CDS, Software & AI, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "FDA CDS Guidance", "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "IMDRF - Software as a Medical Device", "url": "https://www.imdrf.org/working-groups/software-medical-device-samd", "publisher": { "@type": "Organization", "name": "IMDRF" } }, { "@type": "CreativeWork", "name": "MDCG Software Guidance", "url": "https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en", "publisher": { "@type": "Organization", "name": "MDCG" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/samd#term", "name": "Software as a Medical Device", "alternateName": "SaMD", "url": "https://medtechterms.com/terms/samd" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Software & AI", "item": "https://medtechterms.com/terms?cat=Software%20%26%20AI" }, { "@type": "ListItem", "position": 4, "name": "Clinical Decision Support", "item": "https://medtechterms.com/terms/cds" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/cds#faq", "mainEntity": [ { "@type": "Question", "name": "What are the key criteria for CDS software to be excluded from FDA regulation?", "acceptedAnswer": { "@type": "Answer", "text": "The main criteria for exclusion under the Cures Act involve the CDS software providing recommendations that are not intended to acquire or process medical images or signals, for the purpose of informing, rather than driving, clinical management, and allowing the healthcare professional to independently review the basis of the recommendations, and not supporting or providing recommendations in a time-critical situation regarding a diagnosis or treatment." } }, { "@type": "Question", "name": "How does the EU MDR approach CDS software regulation?", "acceptedAnswer": { "@type": "Answer", "text": "Under the EU MDR, software that provides information used to make decisions with diagnostic or therapeutic purposes is generally considered a medical device, with its classification determined by the level of risk it poses to the patient, particularly under Rule 11 of Annex VIII." } }, { "@type": "Question", "name": "What is meant by 'transparency' in the context of CDS regulation?", "acceptedAnswer": { "@type": "Answer", "text": "Transparency means that the healthcare professional can independently review the basis of the CDS recommendations, including the data, inputs, and algorithms used, to understand and critically evaluate the advice provided, rather than blindly following it." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Software & AI](/terms?cat=Software%20%26%20AI) 6. / 7. Clinical Decision Support [All terms](/terms) Software & AI [Software Lifecycle](/ecosystems/software-lifecycle)[Clinical Evidence](/ecosystems/clinical-evidence)CDS # Clinical Decision Support Software providing healthcare professionals with knowledge and patient-specific information. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Clinical Decision Support (CDS) software analyzes data within EHRs or directly from devices to help providers make clinical decisions. Some CDS functions are excluded from FDA device regulation under Section 3060 of the Cures Act when criteria are met. What the regulation says The FDA, under Section 3060 of the 21st Century Cures Act, clarifies that certain Clinical Decision Support (CDS) functions are excluded from the definition of a medical device if they meet specific criteria, primarily focusing on transparency to the user and the absence of a time-critical situation. This is further detailed in FDA guidance documents such as "Clinical Decision Support Software" issued in September 2022. The [EU Medical Device Regulation](/terms/mdr) (EU [MDR](/terms/mdr-reporting) 2017/745) does not have a direct equivalent exclusion, generally classifying software that provides information for diagnostic or therapeutic purposes as a medical device, with classification depending on the risk to the patient, as outlined in Annex VIII, Rule 11. ## What this means in practice Whether a CDS function is a regulated device depends on transparency of the basis for recommendations and time-criticality of the underlying condition. ## Examples - A CDS function analyzing patient data to suggest potential drug interactions, but allowing the physician to review the evidence and make the final prescribing decision, exemplifies an excluded function under the Cures Act. - Software that provides guidance on appropriate diagnostic tests based on a patient's symptoms, where the physician can independently evaluate the rationale, is an example of an excluded CDS. - A CDS system providing real-time alerts for critical vital sign changes in an ICU setting, where immediate action is required, likely falls under FDA regulation due to time-criticality. Common pitfalls - • A common pitfall is assuming all CDS software is exempt from regulation; only specific functions meeting the Cures Act criteria are excluded. - • Misinterpreting "transparency" can lead to non-compliance, as the basis for recommendations must be clearly understandable by a healthcare professional. - • Failing to consider the time-criticality of the clinical situation for which the CDS is intended can result in incorrect regulatory classification. - • Neglecting to update regulatory assessments when CDS functionalities change can lead to non-conforming products. - • Assuming EU MDR classification is identical to FDA Cures Act exemptions will lead to non-compliance in the EU market. ## Frequently asked questions What are the key criteria for CDS software to be excluded from FDA regulation? The main criteria for exclusion under the Cures Act involve the CDS software providing recommendations that are not intended to acquire or process medical images or signals, for the purpose of informing, rather than driving, clinical management, and allowing the healthcare professional to independently review the basis of the recommendations, and not supporting or providing recommendations in a time-critical situation regarding a diagnosis or treatment. How does the EU MDR approach CDS software regulation? What is meant by 'transparency' in the context of CDS regulation? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Software & AI Software as a Medical Device(SaMD) Software intended for medical purposes that performs without being part of a hardware device. ](/terms/samd) ### SaMD & AI/ML Devices · From this learning path [ Software & AI Predetermined Change Control Plan(PCCP) FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices. Adjacent lesson ](/terms/ai-ml-pccp?from=samd-and-ai)[ Software & AI Software of Unknown Provenance(SOUP) Software not developed for medical device use, or lacking adequate development records, incorporated into a device. Adjacent lesson ](/terms/soup?from=samd-and-ai)[ Software & AI Software in a Medical Device(SiMD) Software embedded in or required to operate a hardware medical device. ](/terms/simd?from=samd-and-ai)[ Software & AI Software Safety Classification IEC 62304 classes A, B, C reflecting potential harm from software failure. ](/terms/software-safety-class?from=samd-and-ai) ### Software Team Onboarding · From this learning path [ Standards IEC 62304 Lifecycle requirements for medical device software. ](/terms/iec-62304?from=software-team-onboarding)[ Cybersecurity Section 524B of the FD&C Act(524B) The federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices. Adjacent lesson ](/terms/section-524b?from=software-team-onboarding)[ Quality & Risk Verification & Validation(V&V) Confirming design outputs meet inputs (V) and that devices meet user needs (V). Adjacent lesson ](/terms/verification-validation?from=software-team-onboarding)[ Cybersecurity Secure Product Development Framework(SPDF) A documented, risk-based set of processes that build cybersecurity into a medical device across its full lifecycle. ](/terms/spdf?from=software-team-onboarding) Cited by Where this term appears across MedTech Terms. Learning paths (2) - [SaMD & AI/ML Devices](/paths/samd-and-ai)Lesson 6 of 9 - [Software Team Onboarding](/paths/software-team-onboarding)Lesson 7 of 12 Ecosystems (2) - [Software Lifecycle](/ecosystems/software-lifecycle) - [Clinical Evidence](/ecosystems/clinical-evidence) ## Mentioned in recent activity 12 entries Recalls (10)PubMed (2) [Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medline Kit Number/SKU CDS840402AI; 2. OPEN HEART CDS, Medline Kit Number/SKU CDS984890V; 3. RR-NEURO VASCULAR PACK-LF, Medline Kit Number/SKU DYNJ0394874L; 4. VP SHUNT PACK-LF, Medline Kit Number/SKU DYNJ0750993M; 5. PEDI VP SHUNT ADD A PACK-LF, Medline Kit Number/SKU DYNJ0753933G; 6. FESS-MB PACK-LF, Medline Kit Number/SKU DYNJ0888159I; 7. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861C; 8. POSTERIOR LUMBAR PACK, Medline Kit Number/SKU DYNJ42626B; 9. CV CUTDOWN PACK, Medline Kit Number/SKU DYNJ45374F; 10. X RAY CLOSED PACK, Medline Kit Number/SKU DYNJ48949C; 11. RFD- AAA PACK, Medline Kit Number/SKU DYNJ54242B; 12. NEURO LAM, Medline Kit Number/SKU DYNJ64188A; 13. LIVE OAK SINUS ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ69223; 14. FEM POP PACK, Medline Kit Number/SKU DYNJ81423C; 15. ENS FREEFLAP PROCDURE - LF, Medline Kit Number/SKU DYNJ88249; 16. OPEN HEART A&B, Medline Kit Number/SKU DYNJ901203D; 17. NEURO ACD, Medline Kit Number/SKU DYNJ904549F; 18. KIT VP SHUNT RFD, Medline Kit Number/SKU DYNJ906303F; 19. ACDF-LF, Medline Kit Number/SKU DYNJ906681C; 20. ACDF-LF, Medline Kit Number/SKU DYNJ906681D; 21. ACDF-LF, Medline Kit Number/SKU DYNJ906681F; 22. UNIVERSITY FREE FLAP, Medline Kit Number/SKU DYNJ907196B; 23. UNIVERSITY FREE FLAP, Medline Kit Number/SKU DYNJ907196C; 24. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ908362F; 25. VP SHUNT, Medline Kit Number/SKU DYNJ909379; 26. VP SHUNT, Medline Kit Number/SKU DYNJ909379A. ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2016-2026) Class II · 2026-03-19 [Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. VP SHUNT, Medline Kit Number/SKU CDS840193V; 2. SHY VP SHUNT CDS, Medline Kit Number/SKU CDS982389J; 3. VP SHUNT ADULT PACK-LF, Medline Kit Number/SKU DYNJ0117497G; 4. PICC LINE PACK, Medline Kit Number/SKU DYNJ04592K; 5. VP SHUNT PACK-LF, Medline Kit Number/SKU DYNJ0750993L; 6. PEDI VP SHUNT ADD A PACK-LF, Medline Kit Number/SKU DYNJ0753933F; 7. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861B; 8. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861D; 9. EVD VP SHUNT DBS PACK 319705, Medline Kit Number/SKU DYNJ44603C; 10. BURR HOLE SHUNT PACK, Medline Kit Number/SKU DYNJ56819G; 11. CHRISTUS CHILDRENS VP SHUNT PK, Medline Kit Number/SKU DYNJ61174A; 12. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213C; 13. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213F; 14. NASAL ENDO PACK, Medline Kit Number/SKU DYNJ84501; 15. RO VP SHUNT PACK, Medline Kit Number/SKU PHS392834010D. ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2017-2026) Class II · 2026-03-19 [Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEREOTACTIC CDS, Medline Kit Number/SKU CDS983173G; 2. EPISTAXIS TRAY, Medline Kit Number/SKU DYNDA3240; 3. RHINO PACK, Medline Kit Number/SKU DYNJ46504B; 4. MSC SEPTO RHINO PACK-LF, Medline Kit Number/SKU DYNJ51677B; 5. RHINO/SEPTO/FESS PACK, Medline Kit Number/SKU DYNJ55955C; 6. NASAL PACK, Medline Kit Number/SKU DYNJ67789A. ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2020-2026) Class II · 2026-03-19 [Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. HEAD AND NECK CDS-LF, Medline SKU # CDS780138K; 2. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 3. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 4. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 5. THYROIDECTOMY, Medline SKU # DYNJ910458; 6. LH 3 PORT W/O WASTEBAG, Medline SKU # VASC1081C; 7. LHK, Medline SKU # VASC1510; 8. LHK, Medline SKU # VASC1510. ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1721-2026) Class I · 2026-02-27 [Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M; 4) ANGIOGRAPHY TRAY, Model Number: DYNJT3078; 5) CATH PACK, Model Number: DYNJT4190; 6) ANGIO VASCULAR PACK, Model Number: DYNJT5717; 7) HEART CATH PACK, Model Number: DYNJ0381139R; 8) CARDIAC CATH PACK, Model Number: DYNJ04529L; 9) CUSTOM RADIOLOGY PACK, Model Number: DYNJ07955L; 10) STVZ CARDIAC CATH PACK, Model Number: DYNJ24619J; 11) CATH TRAY #2, Model Number: DYNJ24706D; 12) CATH LAB PACK, Model Number: DYNJ24802Q; 13) CATH PACK, Model Number: DYNJ30268K; 14) HEART CATHETERIZATION PACK, Model Number: DYNJ30927R; 15) HEART CATH TRAY PACK-LF, Model Number: DYNJ31944D; 16) CATH PACK-LF, Model Number: DYNJ33061D; 17) CATH PACK, Model Number: DYNJ34638K; 18) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ38120C; 19) CATH PACK, Model Number: DYNJ40904G; 20) CARDIAC CATH-LF, Model Number: DYNJ41057D; 21) CATH LAB PACK, Model Number: DYNJ41172; 22) ANGIOGRAPHY PACK, Model Number: DYNJ42134G; 23) CATH LAB DRAPE PACK, Model Number: DYNJ42455B; 24) ANGIOGRAPHY PACK, Model Number: DYNJ42543B; 25) CATH LAB PACK, Model Number: DYNJ42900D; 26) ANGIOGRAPHY PACK NO SYR, Model Number: DYNJ43009K; 27) CATH PACK (WITH MANIFOLD), Model Number: DYNJ44515L; 28) ANGIO IR DRAPE PACK 319696, Model Number: DYNJ44593I; 29) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ44850J; 30) CATH LAB PACK, Model Number: DYNJ45296; 31) ANGIO PACK, Model Number: DYNJ50739J; 32) CARDIAC CATH PACK, Model Number: DYNJ51103F; 33) IR ANGIO BODY, Model Number: DYNJ51765D; 34) INTERVENTIONAL TRAY, Model Number: DYNJ52501C; 35) CARDIAC CATH IMF 86040- LF, Model Number: DYNJ53947J; 36) CARDIAC CATH PACK, Model Number: DYNJ54101I; 37) ANGIO KIT, Model Number: DYNJ55686C; 38) CATH LAB PACK, Model Number: DYNJ56141B; 39) ANGIO NEURO PACK, Model Number: DYNJ57685D; 40) CATH PACK, Model Number: DYNJ57729F; 41) CATH PACK, Model Number: DYNJ59632F; 42) CATH LAB PACK WITH NAMIC, Model Number: DYNJ60853D; 43) ANGIO PACK ALEX, Model Number: DYNJ63539C; 44) ANGIOGRAPHY CV RAD PACK, Model Number: DYNJ64936B; 45) CATH LAB PACK, Model Number: DYNJ65185D; 46) CATH PACK, Model Number: DYNJ65619A; 47) CATH I W SPLIT DRAPE PACK, Model Number: DYNJ66182; 48) CATH PACK SHD, Model Number: DYNJ68384B; 49) CATH LAB PACK, Model Number: DYNJ69094B; 50) CATH LAB ACCESSORIES, Model Number: DYNJ69213B; 51) REYES CATH PACK, Model Number: DYNJ69345A; 52) TMH ANGIOGRAPHY TRAY, Model Number: DYNJ80054A; 53) ANGIOGRAPHY TRAY, Model Number: DYNJ80156; 54) CATH PACK, Model Number: DYNJ80516C; 55) CATH PACK, Model Number: DYNJ80730; 56) ANGIO DRAPE PACK 2 WINDOW, Model Number: DYNJ81066B; 57) OR ANGIOGRAM PACK, Model Number: DYNJ81435F; 58) HEART CATH PACK, Model Number: DYNJ81527B; 59) HEART CATH PACK, Model Number: DYNJ83764D; 60) CATH LAB PACK, Model Number: DYNJ84048A; 61) ANGIO TRAY NO LIDO, Model Number: DYNJ85557B; 62) CARDIAC CATH PACK, Model Number: DYNJ85746B; 63) ANGIOGRAPHY PACK, Model Number: DYNJ86313; 64) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ86787; 65) CATH PACK, Model Number: DYNJ87098A; 66) CATH LAB TAVR PACK, Model Number: DYNJ88532; 67) SMT LEFT HEART CATH, Model Number: DYNJ89274; 68) VASCULAR CATH PACK, Model Number: DYNJ89352; 69) CATH LAB PACK, Model Number: DYNJ89805; 70) CARDIAC CATH MERCY WASHINGTON, Model Number: DYNJ89934; 71) ANGIO, Model Number: DYNJ900278G; 72) TAVR ICC VER. F, Model Number: DYNJ904401F; 73) TAVR, Model Number: DYNJ908646C; 74) LHK-UPMC CHILDRENS MAIN OR 2, Model Number: NAM0009; 75) KIT ANGIO CSTM-EVERGREEN, Model Number: NAM0020; 76) GP-CARDIAC CATH PACK-LF, Model Number: PHS397170009D; 77) LEFT HEART KIT - MARION, Model Number: VASC1073A; 78) RHK - VAMC RICHMOND, Model Number: VASC1185B; 79) LHK-MEADOWVIEW REG, Model Number: VASC1263; 80) LHK - BSC 3V ON S10RA, Model Number: VASC1269; 81) LHK - BSC 3V ON S10MLL, Model Number: VASC1270; 82 ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1835-2026) Class II · 2026-02-25 [See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP CABG CDS, Model Number:CDS840087AI; 5) OFF PUMP CABG CDS, Model Number:CDS840087AK; 6) OFF PUMP CABG CDS, Model Number:CDS840087AL; 7) OFF PUMP CABG CDS, Model Number:CDS840087AM; 8) OPEN HEART, Model Number:CDS840150S; 9) OPEN HEART, Model Number:CDS840150T; ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2093-2026) Class II · 2026-01-07 [See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5) MINOR LAPAROTOMY CDS, Model Number: CDS860016P; 6) MINOR LAPAROTOMY CDS, Model Number: CDS860016Q; 7) MINOR LAPAROTOMY CDS, Model Number: CDS860016R; 8) MINOR LAPAROTOMY CDS, Model Number: CDS860016S; 9) LAP GASTRIC BYPASS CDS, Model Number: CDS860146M; ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2098-2026) Class II · 2026-01-07 [See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407P; 3) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 4) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 5) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 6) ROBOTIC-LF, Model Number: CDS984543D; 7) ROBOTIC-LF, Model Number: CDS984543F; 8) ROBOTIC-LF, Model Number: CDS984543G; 9) ROBOTIC-LF, Model Number: CDS984543I; 10) GYN CDS, Model Number: CDS984860F; 11) GYN LAP PELVI, Model Number: CDS985423G; 12) GYN KIT, Model Number: DYKM1657A; 13) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL100; 14) KIT ROBOTICS GYN, Model Number: DYKMBNDL109; 15) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116D; 16) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116F; 17) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119; 18) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119A; 19) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168; 20) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168A; 21) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184D; 22) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91; ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2109-2026) Class II · 2026-01-07 [Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; 4) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A; 5) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116A; 6) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116G; 7) ROBOTIC PACK, Model Number: DYNJ04135B; 8) MINOR LITHOTOMY PACK, Model Number: DYNJ04382J; 9) NBMC D & C PACK-LF, Model Number: DYNJ0665843C; 10) D&C PACK-LF, Model Number: DYNJ22567G; 11) D&C PACK-LF, Model Number: DYNJ22567J; 12) D AND C, Model Number: DYNJ41272B; 13) D AND C, Model Number: DYNJ41272C; 14) OB PACK, Model Number: DYNJ42884; 15) D&C/GYN PACK, Model Number: DYNJ47713A; 16) PERI GYN PACK, Model Number: DYNJ55377D; 17) ANTERIOR CERVICAL-LF, Model Number: DYNJ58344; 18) D&C PACK, Model Number: DYNJ67214D; 19) D&C PACK, Model Number: DYNJ67214F; 20) D&C PACK, Model Number: DYNJ67214G; 21) D&C PACK, Model Number: DYNJ67214I; 22) LITHOTOMY PACK, Model Number: DYNJ80765C; 23) GYN PACK, Model Number: DYNJ83475; 24) D AND C PACK, Model Number: DYNJ87468; 25) D&C-ASC, Model Number: DYNJ900465C; 26) D&C-ASC, Model Number: DYNJ900465D; 27) D&C-ASC, Model Number: DYNJ900465F; 28) GYN LITHOTOMY-LF, Model Number: DYNJ902711L; 29) GYN LITHOTOMY-LF, Model Number: DYNJ902711N; 30) D&C, Model Number: DYNJ906947C; 31) PACK PERI GYN DSMC, Model Number: DYNJT6424 ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-1419-2026) Class II · 2026-01-07 [See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) BREAST-HERNIA-PORT CDS-LF, Model Number: CDS984853J; 3) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117C; 4) KIT PLASTIC INSERT TISSUE EXPA, Model Number: DYKMBNDL158; 5) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170; 6) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170A; 7) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL170B; 8) KIT PLASTIC ABDOMINOPLASTY, Model Number: DYKMBNDL182; ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2099-2026) Class II · 2026-01-07 ## Latest in MedTech [View all](/latest?term=cds) Recent regulatory actions, publications, and trials matched to this term. Updated daily. - PubMed 2026-05-29 [Implementation of an AI-Based Clinical Decision Support System Predicting In-Hospital Cardiac Arrest in General Wards: A Multicenter Staggered-Implementation Study in Secondary Hospitals in Korea. ](https://pubmed.ncbi.nlm.nih.gov/42279550/) Diagnostics (Basel, Switzerland) - PubMed 2026-05-12 [Public Expectations for Food and Drug Administration Approval of AI-Based Clinical Decision Support Tools: Quantitative Study. ](https://pubmed.ncbi.nlm.nih.gov/42118568/) JMIR AI - Recall 2026-03-19 [Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEREOTACTIC CDS, Medline Kit Number/SKU CDS983173G; 2. EPISTAXIS TRAY, Medline Kit Number/SKU DYNDA3240; 3. RHINO PACK, Medline Kit Number/SKU DYNJ46504B; 4. MSC SEPTO RHINO PACK-LF, Medline Kit Number/SKU DYNJ51677B; 5. RHINO/SEPTO/FESS PACK, Medline Kit Number/SKU DYNJ55955C; 6. NASAL PACK, Medline Kit Number/SKU DYNJ67789A. ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=Z-2020-2026) Class II · Medline Industries, LP ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 IMDRF· 1 MDCG· 1 1. [1 FDA CDS Guidance Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software) 2. [2 IMDRF - Software as a Medical Device Verified IMDRF · imdrf.org ](https://www.imdrf.org/working-groups/software-medical-device-samd) 3. [3 MDCG Software Guidance Verified MDCG · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building software-as-a-medical-device? We help SaMD and AI/ML device teams meet IEC 62304 and the FDA's evolving expectations for software cybersecurity. [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 Software & AI Acronym CDS Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=cds) Learn in 60 seconds Card Lesson Quiz Software providing healthcare professionals with knowledge and patient-specific information. - · Whether a CDS function is a regulated device depends on transparency of the basis for recommendations and time-criticality of the underlying condition. - · Some CDS functions are excluded from FDA device regulation under Section 3060 of the Cures Act when criteria are met. Remember this Watch out: A common pitfall is assuming all CDS software is exempt from regulation; only specific functions meeting the Cures Act criteria are excluded. Related terms - [Software as a Medical Device(SaMD) ](/terms/samd) You may also need Auto-suggested from Software & AI and shared keywords. - [Algorithm Change Protocol(ACP) ](/terms/algorithm-change-protocol) - [Medical Device Data System(MDDS) ](/terms/mdds) - [AAMI TIR45(TIR45) ](/terms/aami-tir45) - [ONC HTI-1 / HTI-2 ](/terms/onc-hti) - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) - [De-Identification of Health Data ](/terms/de-identification) [All Software & AI terms](/terms?cat=Software%20%26%20AI) From the Blue Goat network Related resources and services on this topic. - [ AI SaMD Insights How AI is changing SaMD - risk, regulation, and good machine-learning practice. ](https://ai-samd.com) - [ Med Device Cyber Podcast Conversations with medical device cybersecurity practitioners. ](https://mdcpodcast.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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