Module 15 Presentations

15/04/2024

Acceptance of Data From Clinical Investigations for Medical Devices Established in the US

Amendments:

• 21 CFR parts 807, 812, and 814 have been amended to identify criteria for acceptance of clinical data for all premarket submissions, e.g. 510(k), De Novo, PMA • Clinical investigations conducted outside the United States and submitted to support an IDE or device marketing application or submission must now include statements and information regarding how the investigations conform with GCP • Generally – GCP is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of any clinical study/investigation • Provides assurance data and results are credible and accurate and rights, safety, and well-being of subjects are protected according to minimum standards and vulnerable patient population

• Sponsor can choose GCP standard – medical devices default to ISO 14155 – FDA recognised

• “Clinical Investigation of Medical Devices for Human Subjects-Good Clinical Practice” standard, ISO 14155:2020 , represents an international GCP standard for medical devices

The Organisation for Professionals in Regulatory Affairs

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Acceptance of Data From Clinical Investigations for Medical Devices – By Site Location

• Supporting clinical data – apply … provided to support an IDE or device marketing application or submission; for example, when clinical data are submitted in:

• A 510(k) submission to demonstrate substantial equivalence

• A PMA application to demonstrate a reasonable assurance of safety and effectiveness

• An HDE application to demonstrate reasonable assurance of safety and probable benefit

• Supplementary clinical data – Final Rule requirements do not apply

The Organisation for Professionals in Regulatory Affairs

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