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GUIDANCE DOCUMENT

Bridging for Drug-Device and Biologic-Device Combination Products Draft Guidance for Industry December 2019

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2019-D-5585
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products

This guidance provides recommendations to industry and FDA staff on how to approach bridging in new drug applications (NDAs) or biologics license applications (BLAs) for drug-device and biologic-device single entity or copackaged combination products including the following:

  • Bridging of information related to a combination product that employs a different device constituent part or parts with the same drug constituent part or parts as the proposed combination product
  • Bridging of information related to a combination product that employs a different drug constituent part or parts with the same device constituent part or parts as the proposed combination product

 

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-5585.

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