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 Required content includes enrollment status (subjects enrolled, completed, withdrawn), summary of adverse events and UADEs, deviations from the investigational plan, sponsor monitoring activities, IRB activity (approvals, suspensions,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. Reports are due to FDA on the anniversary of the IDE approval and to reviewing IRBs at the frequency the IRB requires.

Why it matters

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.

Sources

21 CFR 812.150 - Reports · eCFR
FDA, IDE Reports · FDA
FDA - Clinical Trials and Human Subject Protection · FDA

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Why compare MedTech terms side by side?

MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

Each comparison on this page pulls from the same vendor-neutral, sourced definitions used throughout the MedTech Terms glossary. You see the one-line summary, the formal definition, why it matters in practice, common pitfalls, and the primary sources (FDA guidance, EU MDR/IVDR articles, ISO/IEC standards, MDCG documents, IMDRF principles) that back each entry. That makes the comparison defensible in regulatory strategy memos, design reviews, and submission narratives.

Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

How to use this tool

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MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.