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Does FDA Require the Investigator to Complete an FDA 1572 for Conducting Clinical Investigations of a Medical Device?

For clinical investigations of medical devices, an FDA 1572 is not required.  However, an investigator agreement is required for clinical investigation of medical devices.  An investigator agreement is not a specific form, it’s an agreement of the PI to conduct the trial according to regulations.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.


  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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