--- title: "Annual Report (PMA), Definition | MedTech Terms" description: "Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/annual-report-pma#term", "name": "Annual Report (PMA)", "description": "21 CFR 814.84 requires PMA holders to submit annual reports within 60 days of the PMA approval anniversary, summarizing unreported changes, adverse reaction summaries, and progress on post-approval study commitments.", "url": "https://medtechterms.com/terms/annual-report-pma", "termCode": "annual-report-pma", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/annual-report-pma#article", "headline": "Annual Report (PMA)", "description": "Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status.", "url": "https://medtechterms.com/terms/annual-report-pma", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/annual-report-pma" }, "about": { "@id": "https://medtechterms.com/terms/annual-report-pma#term" }, "articleSection": "Post-Market", "inLanguage": "en", "keywords": "Annual Report (PMA), 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": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "21 CFR 814.84", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-814", "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" } }, { "@type": "CreativeWork", "name": "EUDAMED Public Site", "url": "https://ec.europa.eu/tools/eudamed/", "publisher": { "@type": "Organization", "name": "European Commission" } } ], "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/post-market-surveillance#term", "name": "Post-Market Surveillance", "alternateName": "PMS", "url": "https://medtechterms.com/terms/post-market-surveillance" } ] }, { "@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": "Annual Report (PMA)", "item": "https://medtechterms.com/terms/annual-report-pma" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/annual-report-pma#faq", "mainEntity": [ { "@type": "Question", "name": "What is the primary purpose of the PMA Annual Report?", "acceptedAnswer": { "@type": "Answer", "text": "The primary purpose is to provide the FDA with an annual summary of any unreported changes, adverse reactions, and the progress of post-approval studies, ensuring continued compliance and device safety." } }, { "@type": "Question", "name": "When is the PMA Annual Report due?", "acceptedAnswer": { "@type": "Answer", "text": "The report must be submitted within 60 days of the anniversary date of the PMA approval." } }, { "@type": "Question", "name": "What kind of information needs to be included in the report?", "acceptedAnswer": { "@type": "Answer", "text": "The report should include summaries of any changes not requiring a PMA supplement, adverse events, and updates on commitments made as part of post-approval studies, as outlined in 21 CFR 814.84(b)." } } ] } ] } --- [ 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. Annual Report (PMA) [All terms](/terms) Post-Market [Regulated Pathways](/ecosystems/regulated-pathways)[Post-Market & Safety](/ecosystems/post-market-safety) # Annual Report (PMA) Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition 21 CFR 814.84 requires [PMA](/terms/pma) holders to submit annual reports within 60 days of the PMA approval anniversary, summarizing unreported changes, adverse reaction summaries, and progress on post-approval study commitments. What the regulation says The FDA, under 21 CFR 814.84, mandates that holders of Premarket Approvals (PMAs) submit annual reports. These reports are crucial for ongoing regulatory oversight, ensuring devices remain [safe](/terms/safe-note) and effective post-market. They summarize changes not previously reported, provide [adverse event](/terms/adverse-event) data, and update on post-approval study progress, as specified in the [PMA](/terms/pma) approval order. ## What this means in practice Late or incomplete [PMA](/terms/pma) Annual Reports trigger Warning Letters and can affect approval status. ## Examples - A manufacturer of an implantable cardiac device includes a summary of minor material supplier changes not requiring a PMA supplement in their annual report. - A company developing a new diagnostic imaging system details the enrollment progress for their post-market clinical follow-up study as part of their annual submission. - An adverse event summary in the annual report highlights a trend of a specific device malfunction, leading the FDA to request further investigation. Common pitfalls - • Failing to submit the annual report within 60 days of the PMA anniversary can lead to regulatory action, including Warning Letters. - • Incomplete annual reports, especially those lacking required summaries of changes or adverse events, are a common pitfall. - • Overlooking the summarization of progress on post-approval study commitments can render the report deficient. - • Assuming no changes or adverse events means no report is necessary is incorrect, as a report confirming this is still required. - • Not maintaining thorough documentation throughout the year to easily compile the annual report can result in last-minute rushes and errors. ## Frequently asked questions What is the primary purpose of the PMA Annual Report? The primary purpose is to provide the FDA with an annual summary of any unreported changes, adverse reactions, and the progress of post-approval studies, ensuring continued compliance and device safety. When is the PMA Annual Report due? What kind of information needs to be included in the report? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Post-Market Post-Market Surveillance(PMS) Activities to monitor device safety and performance after market release. ](/terms/post-market-surveillance)[ Regulatory Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. ](/terms/pma) ### 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 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)[ Post-Market FDA Recall Classifications I, II, III FDA's risk-based grading of recalls based on potential for harm. ](/terms/recall-classifications) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Post-Market & Safety](/ecosystems/post-market-safety) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 eCFR· 1 FDA· 1 European Commission· 1 1. [1 21 CFR 814.84 Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-814) 2. [2 FDA Recalls - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls) 3. [3 EUDAMED Public Site Verified European Commission · ec.europa.eu ](https://ec.europa.eu/tools/eudamed/) 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 Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=annual-report-pma) Learn in 60 seconds Card Lesson Quiz Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status. - · Late or incomplete PMA Annual Reports trigger Warning Letters and can affect approval status. Remember this Watch out: Failing to submit the annual report within 60 days of the PMA anniversary can lead to regulatory action, including Warning Letters. Related terms - [Premarket Approval(PMA) ](/terms/pma) - [Post-Market Surveillance(PMS) ](/terms/post-market-surveillance) You may also need Auto-suggested from Post-Market and shared keywords. - [IDE Annual Progress Report ](/terms/ide-annual-report) - [Medical Device Reporting (FDA)(MDR) ](/terms/mdr-reporting) - [PSUR (IVDR Specific) ](/terms/psur-ivdr) - [Notified Body Scrutiny (IVDR Class D) ](/terms/ivdr-notified-body-scrutiny) - [PMA Supplement Types ](/terms/pma-supplement-types) - [Unanticipated Adverse Device Effect(UADE) ](/terms/uade) [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. 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