An overview of the main clinical study stages a medical device may pass through on the way to, and after, U.S. market authorization.
Stage | Main Questions | Typical Purpose |
|---|---|---|
First-in-human / early feasibility study (EFS) | Can the device be used safely, and does it function as intended? | A small study (typically about 10 subjects or fewer at the outset) conducted early in development, often before the design is final, to assess initial clinical safety and device functionality. Results can inform design changes.An EFS may or may not be first-in-human; some first-in-human studies are traditional feasibility studies. [1] |
Traditional feasibility study | Does a near-final device show enough safety and potential effectiveness to plan a larger study? | Captures preliminary safety and effectiveness data on a near-final or final design to refine the procedure, endpoints, and pivotal study design. Often informally called a “pilot” study. [1] |
Pivotal Study | Is there sufficient evidence to support the marketing submission for the intended use? | The definitive clinical investigation, typically with a statistically justified sample size. For PMA and De Novo, it supports a reasonable assurance of safety and effectiveness; for a 510(k) that requires clinical data, it supports substantial equivalence. [2] |
Post-market study or surveillance | How does the device perform with broader use and longer follow-up? | Examines long-term durability, uncommon adverse events, and real-world performance. FDA may require a post-approval study (for PMA and HDE devices) or Section 522 postmarket surveillance (for certain Class II and III devices). Many postmarket studies and registries are sponsor-initiated. [3][4] |
Notes
• Not every device goes through every stage. Many devices skip early feasibility, and many lower-risk devices cleared through the 510(k) pathway require no clinical study at all; bench and animal testing may be sufficient.
How does India treat device clinical studies?
India regulates medical device clinical studies separately from U.S. FDA, under the Medical Devices Rules, 2017 (MDR 2017), administered by the Central Drugs Standard Control Organisation (CDSCO). A study run in India for a foreign device company follows Indian rules, and U.S. terminology does not map one-to-one. [5][6]
Sources
[1] FDA guidance: Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies (October 2013).
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigational-device-exemptions-ides-early-feasibility-medical-device-clinical-studies-including
[2] FDA guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices (November 2013).
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-considerations-pivotal-clinical-investigations-medical-devices
[3] FDA: Post-Approval Studies Program.
https://www.fda.gov/medical-devices/postmarket-requirements-devices/post-approval-studies-program
[4] FDA: 522 Postmarket Surveillance Studies Program.
https://www.fda.gov/medical-devices/postmarket-requirements-devices/522-postmarket-surveillance-studies-program
[5] CDSCO: Medical Devices Rules, 2017.
https://cdsco.gov.in/opencms/opencms/en/Acts-and-rules/Medical-Devices-Rules/
[6] CDSCO: Medical Devices & Diagnostics (application forms and pathways).
https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/
[7] CDSCO: Regulatory pathway for medical devices under MDR 2017 (PDF).
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/RegulatoryMDR-2017.pdf
This summary is for general information only and is not regulatory or legal advice.
