Module 15 Presentations

15/04/2024

Breakthrough Devices: Eligibility for Application • Medical devices and device-led combination products are eligible • Subject to marketing authorization via Premarket Approval (PMA), De Novo, or 510(k) submissions – all submission types • Meets the breakthrough criteria specified in Section 515B(b) of the Federal Food, Drug & Cosmetic Act Criterion 1:

AND one of: Criterion 2A : Represents a breakthrough technology (novel) Criterion 2B: No approved or cleared alternatives exist (no predicate) Criterion 2C : Significant advantages over existing approved/ cleared alternatives Criterion 2D: Availability of device in best interest of patients – clinical benefits !

Provide for more effective treatment or diagnosis of life threatening or irreversibly debilitating human disease or conditions; More effective requires data to support technical success and probable clinical effectiveness

The Organisation for Professionals in Regulatory Affairs

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Safer Technologies Program or STeP Description Criteria

First Eligibility Factor

Not eligible for Breakthrough Devices Program – less serious nature or disease by the device Should be expected to improvement benefit-risk profile of disease or treatment by one of following: Reduction in the occurrence of a known serious adverse event Reduction in the occurrence of a known device failure mode Reduction in the occurrence of a known use-related hazard or use error Improvement in the safety or another device or intervention

Second Eligibility Factor

The Organisation for Professionals in Regulatory Affairs

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