Module 5 Presentations

16/07/2024

Governing Regulations for Investigational Products (US)

Medicinal products (Drugs)

Software as a Medical Device (SaMD)

Integral Drug Device Combination

In-Vitro Diagnostic (IVD)

Non-integral Drug Device Combination

Companion Diagnostic (CDx)

Medical Device

Combination Product Regs 21 CFR 4 (DRUG: primary mode of action)

Device Regs 21 CFR 812 IDEs

Drug Regs 21 CFR 312

M-GB-00018492 Date of preparation: July 2024

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Global standards covering Good Study Practice: In Vitro Diagnostic performance studies and medical device clinical investigations

ISO 20916 covers good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes.

ISO 14155 covers good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.

As opposed to country specific regulation, the International Standards are globally applicable and take precedence in matters of conduct of the device study. Note that US FDA does not recognize the ISO 20916.

M-GB-00018492 Date of preparation: July 2024

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