Abstract
Government regulation of drugs, biologics, and devices in medicine has been established to protect patients from false claims and dangerous, unproven therapies. This protection has created hurdles for the development of new cartilage repair techniques and technologies. In the United States, the Federal Food and Drug Administration (FDA) is the body that governs the regulation of cartilage repair development. The focus of this chapter is to offer an understanding of the FDA’s history, mechanisms, and handling of cartilage technologies, as the FDA has been a standard that many industrialized nations loosely follow. As some countries recognize the shortcomings of some aspects of the FDA’s approach, they have taken innovative steps, e.g., Japan. This review sets a backdrop for the future of regulation. Understanding the nuances of the regulatory guidelines is essential during the development of new ideas, evaluation of new technologies, and progress in clinical application.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Lyman S, et al. Cartilage-repair innovation at a standstill methodologic and regulatory pathways to breaking free. J Bone Joint Surg Am. 2016;98(1–8):e63.
FDA Oks Regentis Biomaterials trial for GelrinC knee cartilage treatment. In: DEVICETALKS. 2016. Available at http://www.massdevice.com/fda-oks-regentis-biomaterials-trial-gelrinc-knee-cartilage-treatment/. Accessed 13 Sept 2017.
FDA guidance: “Design considerations for pivotal clinical investigations for medical devices”. In: cdrhlearn. 2013. Available at: https://www.fda.gov/downloads/training/cdrhlearn/ucm377490.pdf. Accessed 13 Sept 2017.
When and why was FDA formed?. In: FDA basics. 2017. Available at https://www.fda.gov/AboutFDA/Transparency/Basics/ucm214403.htm. Accessed 24 March 2017.
History. In: What we do. 2015. Available at https://www.fda.gov/AboutFDA/WhatWeDo/History/default.htm. Accessed 24 March 2017.
What does FDA do?. In: FDA basics. 2017. Available at https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194877.htm. Accessed 24 March 2017.
Investigational Device Exemptions (IDEs) for early feasibility medical device clinical studies, including certain First in Human (FIH) studies. In: Guidance documents. 2013. Available at https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm279103. Accessed 13 Sept 2017.
McGowan KB. Regulatory challenges for cartilage repair technologies. Cartilage. 2013;4(1):4–11.
Carticel. In: Approved products. 2017. Available at https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm134025.htm. Accessed 28 Aug 2017.
MACI. In: Approved products. 2017. Available at https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm533177.htm. Accessed 28 Aug 2017.
S.2689 – REGROW Act. In: 114th Congress (2015–2016). 2016. Available at https://www.congress.gov/bill/114th-congress/senate-bill/2689. Accessed 24 March 2017.
Guidance for industry expedited programs for serious conditions – drugs and biologics. In: Guidances. 2014. Available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf. Accessed 10 July 2017.
Inside the 21st Century Cures Act. In: Spring 2017. Available at http://www.cancertodaymag.org/Spring2017/Pages/Inside-the-21st-Century-Cures-Act.aspx. Accessed 10 July 2017.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2018 Springer International Publishing AG, part of Springer Nature
About this chapter
Cite this chapter
Anz, A.W., Pinegar, C.O. (2018). The Regulatory Environment for Emerging Cartilage Repair Technologies. In: Farr, J., Gomoll, A. (eds) Cartilage Restoration. Springer, Cham. https://doi.org/10.1007/978-3-319-77152-6_12
Download citation
DOI: https://doi.org/10.1007/978-3-319-77152-6_12
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-77151-9
Online ISBN: 978-3-319-77152-6
eBook Packages: MedicineMedicine (R0)