Module 14 2022

22/03/2022

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

The Organisation for Professionals in Regulatory Affairs

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37

EEA: Device content of an MAA

Article 117 all applications for an integral medicinal product should include evidence of the conformity of the device (part) with the relevant GSPRs set out in Annex I of Regulation (EU) 2017/745

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

38

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