Module 14: Design Development and Certification of Medical Devices

17/11/2023

If the device is part of a medicinal product

What if the device is part of a Drug Device Combination product following a medicinal product regulatory pathway.

How does the device information fit with the medicine file

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USA: Device content within NDA/BLA

Module 3

Cross References

3.2.R Device Constituent Part • Administrative • Description & Design Features • Manufacturing • Labelling • Device Life • Biocompatibility • Software • Safety • Functionality & Performance • Attachments

P1 Description & Composition

P2 Pharmaceutical Development

P5 Control of Drug Product

P7 Container Closure

P3 Manufacture

P8 Stability

P2.4 – Container Closure

Product Description

P3.1 - Facilities

P5.1 - Specifications

P7 - Descriptions

P8.1 – Stability Summary

P3.3 Manufacturing Process

P2.5 – Microbiology

P5.2 - Procedures

P7 - Specifications

P8.2 – Stability Commitments

P2.6 – Compatibility

P5.3 - Validation

P7 – Test Methods

P8.3 – Stability Data

Applicant Supplier

Links to Master Files

List of subsections is indicative and not exhaustive

Device MAF

Type III DMF

Type III DMF

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