--- title: "IDE Annual Progress Report, Definition | MedTech Terms" description: "Annual report sponsors must submit to FDA summarizing the progress of an approved IDE study, including enrollment, deviations, and adverse events." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ide-annual-report#term", "name": "IDE Annual Progress Report", "alternateName": [ "IDE Annual Report", "812.150(b)(5) report" ], "description": "Under 21 CFR 812.150(b)(5), IDE sponsors must submit a Progress Report to FDA at least yearly, summarizing the conduct of the investigation. Required content includes enrollment status (subjects enrolled, completed, withdrawn), summary of adverse events and UADEs, deviations from the investigational plan, sponsor monitoring activities, IRB activity (approvals, suspensions, terminations), and any other information relevant to the rights, safety, or welfare of subjects. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Clinical & Trials](/terms?cat=Clinical%20%26%20Trials) 6. / 7. IDE Annual Progress Report [All terms](/terms) Clinical & Trials [Clinical Evidence](/ecosystems/clinical-evidence)[Post-Market & Safety](/ecosystems/post-market-safety)[Global Markets](/ecosystems/global-markets) # IDE Annual Progress Report Annual report sponsors must submit to FDA summarizing the progress of an approved IDE study, including enrollment, deviations, and adverse events. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed June 20, 2026 ## Definition Under 21 CFR 812.150(b)(5), [IDE](/terms/ide) sponsors must submit a Progress Report to FDA at least yearly, summarizing the conduct of the investigation. Required content includes enrollment status (subjects enrolled, completed, withdrawn), summary of adverse events and UADEs, deviations from the investigational plan, sponsor monitoring activities, [IRB](/terms/irb) activity (approvals, suspensions, terminations), and any other information relevant to the rights, safety, or welfare of subjects. Reports are due to FDA on the anniversary of the IDE approval and to reviewing IRBs at the frequency the IRB requires. What the regulation says 21 CFR 812.150(b)(5) defines content and timing. FDA's BIMO Compliance Program 7348.811 (Sponsors, Contract Research Organizations, and Monitors) is the inspection reference. ## What this means in practice [IDE](/terms/ide) annual reports are routinely reviewed by FDA bioresearch monitoring (BIMO) inspectors and are a leading source of Form 483 findings when content is incomplete or late. Sponsors should treat annual report preparation as an opportunity for portfolio-level oversight: cross-site enrollment trends, deviation patterns, and AE rates often reveal study conduct issues that warrant intervention before the next report. Common pitfalls - • Missing the annual deadline, reports are due on the anniversary of IDE approval, not the calendar year. - • Reporting only aggregate counts without trend analysis, sponsors are expected to interpret, not just summarize. - • Treating the annual report as administrative, it is a sponsor compliance artifact reviewed by FDA inspectors. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Clinical & Trials IDE Supplement Amendment to an approved Investigational Device Exemption for protocol or device changes. ](/terms/ide-supplement)[ Clinical & Trials Investigational Device Exemption(IDE) FDA authorization to use an investigational device in a clinical study. ](/terms/ide)[ Clinical & Trials Investigator Brochure(IB) Compilation of clinical and nonclinical information on an investigational device given to clinical investigators, establishes what's 'anticipated' for UADE determinations. ](/terms/investigator-brochure)[ Clinical & Trials Protocol Deviation Departure from the approved clinical investigation plan. ](/terms/protocol-deviation) ### Clinical Trials & Evidence · From this learning path [ Clinical & Trials Institutional Review Board(IRB) Board that reviews and approves human-subjects research at an institution. Adjacent lesson ](/terms/irb?from=clinical-trials-and-evidence)[ Clinical & Trials Adaptive Trial Design Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data. ](/terms/adaptive-trial?from=clinical-trials-and-evidence)[ Clinical & Trials Adverse Event(AE) Any untoward medical occurrence in a subject, whether or not related to the device. ](/terms/adverse-event?from=clinical-trials-and-evidence)[ Clinical & Trials Clinical Evaluation Report(CER) Documented assessment of clinical data demonstrating EU MDR conformity for a device. ](/terms/cer?from=clinical-trials-and-evidence) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [Clinical Trials & Evidence](/paths/clinical-trials-and-evidence)Lesson 3 of 18 Ecosystems (3) - [Clinical Evidence](/ecosystems/clinical-evidence) - [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 eCFR· 1 FDA· 2 1. [1 21 CFR 812.150 - Reports Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-812/subpart-G/section-812.150) 2. [2 FDA IDE Reports Guidance Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/investigational-device-exemption-ide/reports) 3. [3 FDA - Clinical Trials and Human Subject Protection Verified FDA · fda.gov ](https://www.fda.gov/science-research/science-and-research-special-topics/clinical-trials-and-human-subject-protection) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Clinical evidence intersecting with device security? We support clinical-stage MedTech teams whose investigational devices touch patient data or hospital networks. [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 Clinical & Trials Sources 3 Updated 6/20/2026 [Compare with another term](/compare?a=ide-annual-report) Learn in 60 seconds Card Lesson Quiz Annual report sponsors must submit to FDA summarizing the progress of an approved IDE study, including enrollment, deviations, and adverse events. - · IDE annual reports are routinely reviewed by FDA bioresearch monitoring (BIMO) inspectors and are a leading source of Form 483 findings when content is incomplete or late. - · Reports are due to FDA on the anniversary of the IDE approval and to reviewing IRBs at the frequency the IRB requires. Remember this Watch out: Missing the annual deadline, reports are due on the anniversary of IDE approval, not the calendar year. Related terms - [Investigational Device Exemption(IDE) ](/terms/ide) - [IDE Supplement ](/terms/ide-supplement) - [Unanticipated Adverse Device Effect(UADE) ](/terms/uade) - [Investigator Brochure(IB) ](/terms/investigator-brochure) - [Protocol Deviation ](/terms/protocol-deviation) - [Post-Market Surveillance(PMS) ](/terms/post-market-surveillance) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [Annual Report (PMA) ](/terms/annual-report-pma) - [Refuse to Accept (Cybersecurity)(RTA (cyber)) ](/terms/rta-cyber) - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) - [Trend Reporting (MDR/MIR) ](/terms/trend-reporting) - [Clinical Investigation Plan(CIP) ](/terms/cip) - [Emergency Use Authorization(EUA) ](/terms/eua) [All Clinical & Trials terms](/terms?cat=Clinical%20%26%20Trials) From the Blue Goat network Related resources and services on this topic. - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.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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