Regulatory Aspects: Regulation of Cell-Free Biomaterial Implants

Nan Zhang; Alexander Baume; Richard Payne; Julie Allickson

doi:10.1016/B978-0-12-802225-2.00020-9

Regulatory Aspects: Regulation of Cell-Free Biomaterial Implants

Nan Zhang, Alexander Baume, Richard Payne, Julie Allickson

Laboratory Medicine and Pathology

Research output: Chapter in Book/Report/Conference proceeding › Chapter

Abstract

In general, biomaterials used in medicine are regulated as medical devices. Regulation of devices has become an area of difficulty for product developers and regulatory bodies alike. For regulators, it poses challenges to properly ensure these complex devices are safe and effective for patients by creating new regulatory frameworks. For product developers, the difficulty becomes navigating this regulatory framework correctly and in the most efficient manner. This chapter aims to summarize the regulatory pathways for tissue engineering products and provide specific guidance for the development of biomaterials from research to clinical studies.

Original language	English (US)
Title of host publication	In Situ Tissue Regeneration
Subtitle of host publication	Host Cell Recruitment and Biomaterial Design
Publisher	Elsevier Inc.
Pages	383-403
Number of pages	21
ISBN (Electronic)	9780128025000
ISBN (Print)	9780128022252
DOIs	https://doi.org/10.1016/B978-0-12-802225-2.00020-9
State	Published - Aug 5 2016

Keywords

Biocompatibility
Biomaterials
FDA regulations
Investigational Device Exemption
Medical devices
Polymers
Tissue engineering

ASJC Scopus subject areas

General Medicine

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10.1016/B978-0-12-802225-2.00020-9

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abstract = "In general, biomaterials used in medicine are regulated as medical devices. Regulation of devices has become an area of difficulty for product developers and regulatory bodies alike. For regulators, it poses challenges to properly ensure these complex devices are safe and effective for patients by creating new regulatory frameworks. For product developers, the difficulty becomes navigating this regulatory framework correctly and in the most efficient manner. This chapter aims to summarize the regulatory pathways for tissue engineering products and provide specific guidance for the development of biomaterials from research to clinical studies.",

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KW - Polymers

KW - Tissue engineering

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Regulatory Aspects: Regulation of Cell-Free Biomaterial Implants

Abstract

Keywords

ASJC Scopus subject areas

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