Module 18 2021

07/02/2021

Approval process

• A combination product will most likely require – a PMA application if classified as device, – an NDA if classified as drug, or – a BLA if classified as a biological product.

Some CDRH assigned combination products may use 510k if there is a predicate device available.

• Early and close interaction with the FDA review Center is always encouraged to facilitate the process and the increase the likelihood of a successful application.

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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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