Regulatory Aspects: Regulation of Cell-Free Biomaterial Implants

Nan Zhang, Alexander Baume, Richard Payne, Julie Allickson

Research output: Chapter in Book/Report/Conference proceedingChapter


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 languageEnglish (US)
Title of host publicationIn Situ Tissue Regeneration
Subtitle of host publicationHost Cell Recruitment and Biomaterial Design
PublisherElsevier Inc.
Number of pages21
ISBN (Electronic)9780128025000
ISBN (Print)9780128022252
StatePublished - Aug 5 2016


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

ASJC Scopus subject areas

  • General Medicine


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