--- title: "Section 522 Definition & Meaning | MedTech Terms" description: "FDA's authority to order manufacturers to conduct post-market surveillance studies on certain Class II or Class III devices." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/section-522#term", "name": "Section 522 Postmarket Surveillance", "alternateName": [ "Section 522", "522 study", "FD&C Act §522" ], "description": "Section 522 of the Federal Food, Drug, and Cosmetic Act gives FDA authority to require manufacturers to conduct post-market surveillance of Class II or Class III devices when the device meets one of four conditions: failure of the device would be reasonably likely to have serious adverse health consequences; the device is expected to have significant use in pediatric populations; the device is intended to be implanted in the body for more than one year; or the device is intended to be a life-sustaining or life-supporting device used outside a device-user facility. FDA issues a Section 522 order specifying the surveillance question, study design expectations, and timing.", "url": "https://medtechterms.com/terms/section-522", "termCode": "section-522", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/section-522#article", "headline": "Section 522, Section 522 Postmarket Surveillance", "description": "FDA's authority to order manufacturers to conduct post-market surveillance studies on certain Class II or Class III devices.", "url": "https://medtechterms.com/terms/section-522", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/section-522" }, "about": { "@id": "https://medtechterms.com/terms/section-522#term" }, "articleSection": "Post-Market", "inLanguage": "en", "keywords": "Section 522 Postmarket Surveillance, Section 522, 522 study, FD&C Act §522, Post-Market, 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": "2026-06-20", "dateModified": "2026-06-20", "citation": [ { "@type": "CreativeWork", "name": "Section 522 Postmarket Surveillance Studies Program", "url": "https://www.fda.gov/medical-devices/postmarket-requirements-devices/postmarket-surveillance-studies-program", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "21 CFR Part 822", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-822", "publisher": { "@type": "Organization", "name": "eCFR" } }, { "@type": "CreativeWork", "name": "FDA Recalls - Medical Devices", "url": "https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls", "publisher": { "@type": "Organization", "name": "FDA" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/pma#term", "name": "Premarket Approval", "alternateName": "PMA", "url": "https://medtechterms.com/terms/pma" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/510k#term", "name": "510(k) Premarket Notification", "alternateName": "510(k)", "url": "https://medtechterms.com/terms/510k" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/post-market-surveillance#term", "name": "Post-Market Surveillance", "alternateName": "PMS", "url": "https://medtechterms.com/terms/post-market-surveillance" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/pmcf#term", "name": "Post-Market Clinical Follow-up", "alternateName": "PMCF", "url": "https://medtechterms.com/terms/pmcf" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/real-world-evidence#term", "name": "Real-World Evidence", "alternateName": "RWE", "url": "https://medtechterms.com/terms/real-world-evidence" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/mdr-reporting#term", "name": "Medical Device Reporting (FDA)", "alternateName": "MDR", "url": "https://medtechterms.com/terms/mdr-reporting" } ] }, { "@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": "Post-Market", "item": "https://medtechterms.com/terms?cat=Post-Market" }, { "@type": "ListItem", "position": 4, "name": "Section 522 Postmarket Surveillance", "item": "https://medtechterms.com/terms/section-522" } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Post-Market](/terms?cat=Post-Market) 6. / 7. Section 522 Postmarket Surveillance [All terms](/terms) Post-Market [Post-Market & Safety](/ecosystems/post-market-safety)[Global Markets](/ecosystems/global-markets)Section 522 # Section 522 Postmarket Surveillance FDA's authority to order manufacturers to conduct post-market surveillance studies on certain Class II or Class III devices. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed June 20, 2026 ## Definition Section 522 of the Federal Food, Drug, and Cosmetic Act gives FDA authority to require manufacturers to conduct [post-market surveillance](/terms/post-market-surveillance) of Class II or Class III devices when the device meets one of four conditions: failure of the device would be reasonably likely to have serious adverse health consequences; the device is expected to have significant use in pediatric populations; the device is intended to be implanted in the body for more than one year; or the device is intended to be a life-sustaining or life-supporting device used outside a device-user facility. FDA issues a Section 522 order specifying the surveillance question, study design expectations, and timing. What the regulation says FD&C Act §522 (21 U.S.C. §360l) and 21 CFR Part 822. FDA publishes the current list of active 522 orders and accepts study plans, status updates, and final reports through CDRH. ## What this means in practice Section 522 orders are the FDA tool for generating [real-world evidence](/terms/real-world-evidence) on questions left open at clearance, long-term implant performance, rare adverse events, pediatric outcomes, or post-market changes in user environments. Manufacturers must respond to an order within 30 days with a proposed plan and within 15 months begin surveillance. Failure to comply has significant consequences including misbranding determinations. The 522 study list is published and updated regularly by FDA. Common pitfalls - • Treating a 522 order as a clinical study like an IDE, 522 surveillance is post-market and the study design questions are different (often registry-based or real-world data). - • Missing the 30-day plan deadline, FDA can take enforcement action for non-response. - • Designing a 522 study without engaging the sponsor's medical and statistical teams early, 522 questions are often hard to answer without large real-world data sources. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Post-Market Medical Device Reporting (FDA)(MDR) FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions. ](/terms/mdr-reporting)[ Post-Market Post-Market Clinical Follow-up(PMCF) Proactive collection of clinical data on a CE-marked device to confirm safety and performance. ](/terms/pmcf)[ Post-Market Post-Market Surveillance(PMS) Activities to monitor device safety and performance after market release. ](/terms/post-market-surveillance)[ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k) ### More in Post-Market · Same category [ Post-Market 5-Day Report Expedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm. ](/terms/five-day-report)[ Post-Market Annual Report (PMA) Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status. ](/terms/annual-report-pma)[ Post-Market Customer Notification Letter Communication to users notifying them of a safety issue, corrective action, or important product information. ](/terms/customer-notification)[ Post-Market Electronic Medical Device Reporting(eMDR) FDA's mandatory electronic submission system for Medical Device Reports. ](/terms/emdr) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Post-Market & Safety](/ecosystems/post-market-safety) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 2 eCFR· 1 1. [1 Section 522 Postmarket Surveillance Studies Program Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/postmarket-requirements-devices/postmarket-surveillance-studies-program) 2. [2 21 CFR Part 822 Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-822) 3. [3 FDA Recalls - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Post-market cybersecurity surveillance? We help MedTech teams stand up vulnerability monitoring, coordinated disclosure, and post-market reporting workflows. [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 Post-Market Acronym Section 522 Sources 3 Updated 6/20/2026 [Compare with another term](/compare?a=section-522) Learn in 60 seconds Card Lesson Quiz FDA's authority to order manufacturers to conduct post-market surveillance studies on certain Class II or Class III devices. - · Manufacturers must respond to an order within 30 days with a proposed plan and within 15 months begin surveillance. - · Failure to comply has significant consequences including misbranding determinations. - · FDA issues a Section 522 order specifying the surveillance question, study design expectations, and timing. Remember this Watch out: Treating a 522 order as a clinical study like an IDE, 522 surveillance is post-market and the study design questions are different (often registry-based or real-world data). Related terms - [Premarket Approval(PMA) ](/terms/pma) - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [Post-Market Surveillance(PMS) ](/terms/post-market-surveillance) - [Post-Market Clinical Follow-up(PMCF) ](/terms/pmcf) - [Real-World Evidence(RWE) ](/terms/real-world-evidence) - [Medical Device Reporting (FDA)(MDR) ](/terms/mdr-reporting) You may also need Auto-suggested from Post-Market and shared keywords. - [Emergency Use Authorization(EUA) ](/terms/eua) - [Section 524B of the FD&C Act(524B) ](/terms/section-524b) - [FDA Recall Classifications I, II, III ](/terms/recall-classifications) - [Post-Market Performance Follow-up(PMPF) ](/terms/pmpf) - [Clinical Performance (IVDR) ](/terms/ivdr-clinical-performance) - [IVDR Legacy Device ](/terms/ivdr-legacy-device) [All Post-Market terms](/terms?cat=Post-Market) From the Blue Goat network Related resources and services on this topic. - [ 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. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)