Biomaterials and regulatory science

doi:10.1016/j.jmst.2022.04.018

Abstract

Abstract:

The fast development of both biomaterials and regulatory science calls for a convergence, which is addressed in this article via their link through medical products of biomaterials and related safety and efficacy evaluation. The updated definition of biomaterials, and concepts of biomaterials-related medical products and so-called medical-grade and implantable materials are firstly introduced. Then a brief overview of the concept and history of regulatory science and its assessment of safety and efficacy of medical products, as well as the currently ongoing biomaterials-related regulatory science programs are presented. Finally, the opportunities provided by regulatory science for biomaterials as well as challenges on how to develop a biomaterials-based regulatory science system are discussed. As the first article in the field to elucidate the relationship between biomaterials and regulatory science, key take-home messages include (1) biomaterials alone are not medical products; (2) regulatory authorities approve/clear final medical products, not biomaterials; (3) there is no definition/regulation on the so-called medical-grade or implantable materials; and (4) safety and efficacy refer to final medical products, not biomaterials alone.

Key words: Biomaterials, Medical products, Regulatory science, Safety, Efficacy

Song Xu, Tang Zhonglan, Liu Wenbo, Chen Kuan, Liang Jie, Yuan Bo, Lin Hai, Zhu Xiangdong, Fan Yujiang, Shi Xinli, Zhao Peng, Yang Lei, Zhang Kai, G. Mikos Antonios, Zhang Xingdong. Biomaterials and regulatory science[J]. J. Mater. Sci. Technol., 2022, 128: 221-227.

Figures/Tables 4

References 59

[1]	X. Zhang, D. Williams, Deﬁnitions of Biomaterials for the Twenty-ﬁrst Century, Elsevier, Amsterdam, 2019.
[2]	D.F. Williams,in:Proceedings of A Consensus Conference of the European So-ciety for Biomaterials, Chester, England, 1986 March 3-5.
[3]	Y.N. Ertas, M. Mahmoodi, F. Shahabipour, V. Jahed, S.E. Diltemiz, R. Tutar, N. Ashammakhi, Emerg. Mater. 4 (2021) 35-55.
[4]	J. Zarubova, X. Zhang, T. Hoffman, M.M. Hasani-Sadrabadi, S. Li, Matter 4 (2021) 1528-1554.
[5]	A .K. Roy, A. -A .D. Jones T.J. Webster, in: L.Yang, S.B. BhaduriT.J. Webster (Academic Press, Washington DC,Eds.), Biomaterials in Translational Medicine, 2019, pp. 1-22.
[6]	K. Zhang, A.G. Mikos, R.L. Reis, X. Zhang, Bioact. Mater. 18 (2022) 337-338. DOI PMID
[7]	F. Feng, M. Chen, X. Wang, H. Zhang, H. Nie, H. Tang, Bioact. Mater. 10 (2022) 345-354. DOI PMID
[8]	M.A. Serban, Curr. Opin. Biotechnol. 40 (2016) 31-34. DOI URL
[9]	G.D. Prestwich, S. Bhatia, C.K. Breuer, C.Mason S.L.Dahl, R. McFarland, D.J. Mc-Quillan, J. Sackner-Bernstein, J. Schox, W.E. Tente, A. Trounson, Sci. Transl. Med. 4 (2012) 160cm14.
[10]	W. Liu, X. Shi, Z. Lu, L. Wang, K. Zhang, X. Zhang, J. Biomed. Mater. Res. B-Appl. Biomater. 106 (2018) 2093-2100.
[11]	J. Tian, X. Song, Y. Wang, M. Cheng, S. Lu, W. Xu, G. Gao, L. Sun, Z. Tang, M. Wang, X. Zhang, Bioact. Mater. 10 (2022) 492-503.
[12]	W. Liu, Y. Xie, Y. Zheng, W. He, K. Qiao, H. Meng, Bioact. Mater. 6 (2021) 420-432.
[13]	P. Zhao, W. Liu, J. Tian, X. Shi, X. Gu, A.G. Mikos, Engineering (2021), doi: 10. 1016/j.eng.2021.08.021. DOI
[14]	USP Classiﬁcation of Plastics (USP < 88>Biological Reactivity Tests, In Vivo). http://www.uspbpep.com/usp29/v29240/usp29nf24s0_c88.html.2022
[15]	J.T. Blackford, L.W. Blackford, J. Disegi, M. Bohner, in: J.A. Auer, J.A. Stick (Eds.), Equine Surgery (Third Edition), W.B. Saunders, Saint Louis, 2006, pp. 96-111.
[16]	A.U. Daniels, Swiss Med. Wkly. 29 (2012) 1-16.
[17]	M.V. Thomas, D.A. Puleo, J. Biomed. Mater. Res. B-Appl. Biomater. 88B (2009) 597-610.
[18]	A. Kutkut, S. Andreana,J. Long-Term Eff. Med. Implants. 20 (2010) 295-301.
[19]	J.Simon, in: W.R. Wagner, S.E. Sakiyama-Elbert, G. Zhang, M.J. Yaszemski (Eds.), Biomaterials Science (Fourth Edition), Academic Press, Washington, DC, 2020, pp. 1447-1456.
[20]	N.J. Hallab, J.J. Jacobs, J. Black, M.J. Iverson, AAOS On-Line Service January 1997 Bulletin Biomaterials Crisis Looms. .
[21]	A. Hamburg Margaret, Science 331 (2011) 987-987.
[22]	T. Tominaga, Y. Asahina, Y. Uyama, T. Kondo, Clin. Pharmacol. Ther. 90 (2011) 29-31. DOI PMID
[23]	U.S. Food and Drug Administration, Advancing Regulatory Science. .
[24]	U.S. Food and Drug Administration, CDRH Regulatory Science Priorities (FY 2017). .
[25]	U.S. Food and Drug Administration, Regulatory Science. .
[26]	A .A. Moghissi S.R. Straja, B.R. Love, D.K. Bride, R.R. Stough, Technol. Innovation 16 (2014) 155-165.
[27]	RSI: Institute for Regulatory Science,http://nars.org/,October31,2018.
[28]	S. Jasanoff, The Fifth Branch: Science Advisers As Policymakers, Harvard Uni-versity Press, Cambridge, MA, 1990.
[29]	FDA Science and Misson at Risk,Report of the Subcommittee on Sciecnce and Technology. http://www.mpwhi.com/fda_and_americans1.pdf,November2007.
[30]	Pharmaceutical and Medical Devices Agency, PMDA International Strategic Plan 2015. https://www.pmda.go.jp/int-activities/outline/0028.html,July26,2015.
[31]	European Medicines Agency,EMA Regulatory Science to 2025: Strategic Reflection, EMA/110706/ 2020. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/ema-regulatory-science-2025-strategic-reflection_en.pdf,March2020.
[32]	ISO/IEC Guide 51:2014-04. https://www.iso.org/standard/53940.html.
[33]	K. Zhang, X. Zhang, Precise Force, Multi-dimensional Practice "Internal and External Repair" to Ensure the Safety and Eﬃcacy of Medical Devices. http://bk.cnpharm.com/zgyyb/2020/06/09/app_310589.html,June9,2020.
[34]	O. Faris, J. Shuren, N. Engl. J. Med. 376 (2017) 1350-1357. DOI URL
[35]	U.S. Food and Drug Administration, 21st Century Cures Act. https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act,January31,2020.
[36]	U.S.Food and Drug Administration, Medical Device Safety Action Plan: protecting Patients, Promoting Public Health. https://www.fda.gov/about-fda/cdrh-reports/medical-device-safety-action-plan-protecting-patients-promoting-public-health,January5,2021.
[37]	U.S. Food and Drug Administration, Safer Technologies Program for Medi- cal Devices. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safer-technologies-program-medical-devices,June1,2021.
[38]	U.S. Food and Drug Administration, Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on Efforts to Evaluate Materials in Medical Devices to Address Potential Safety Questions. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-jeff-shuren-md-director-center-devices-and-3?utm_campaign=FDA%20Statement%20on%20Efforts%20to%20Evaluate%20Materials%20in%20Medical%20Devices&utm_medium=email&utm_source=Eloqua,April2,2019.
[39]	U.S. Food and Drug Administration, Statement on Continued Efforts to Evaluate Materials in Medical Devices to Address Potential Safety Questions.https://www.fda.gov/news-events/press-announcements/statement-continued-efforts-evaluate-materials-medical-devices-address-potential-safety-questions,September30,2019.
[40]	U.S. Food and Drug Administration, Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices-Part 1:evaluation and Testing Within A Risk Management Process". https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and,September4,2020.
[41]	U.S. Food and Drug Administration, Biological Responses to Metal Implants. https://www.fda.gov/media/131150/download,September2019.
[42]	U.S. Food and Drug Administration, Epidemiological Evidence on the Adverse Health Effects Reported in Relation to Mercury from Dental Amalgam. https://www.fda.gov/media/131151/download,September2019.
[43]	The People’s Repbulic Of China, National Medical Products Administration Launches China’s Drug Regulatory Scientiﬁc Action Plan,May 2, 2019 http://www.gov.cn/xinwen/2019-05/02/content_5388253.htm.
[44]	National Medical Products Administration, The Second Batch of Key Projects of China’s Drug Regulatory Scientiﬁc Action Plan, 06/28/ 2021. https://www.nmpa.gov.cn/yaowen/ypjgyw/20210628171415103.html.
[45]	Key Projects of “Research and Development of Biomaterials and Repair and Replacement of Tissues and Organs (2019) ”. http://www.most.gov.cn/xxgk/xinxifenlei/fdzdgknr/qtwj/qtwj2019/201907/W020190723377141877897.pdf.
[46]	Key Projects of “Research and Development of Biomaterials and Repair and Re- placement of Tissues and Organs (2016) ”. http://www.most.gov.cn/tztg/201603/t20160308_124542.html.
[47]	Key Projects of “Research and Development of Biomaterials and Repair and Replacement of Tissues and Organs (2018) ”. http://www.most.gov.cn/xxgk/xinxifenlei/fdzdgknr/qtwj/qtwj2017/201712/t20171212_136764.html.
[48]	Key Projects of “Medical Equipment and Biomaterials (2021 -2025) ”. https://service.most.gov.cn/kjjh_tztg_all/20210517/4307.html.
[49]	Biomaterials Innovation and Cooperation Platform. https://www.bmicp.org.cn/newsinfo/1379594.html,April15,2021.
[50]	ISO: Standards in Our World. https://www.iso.org/sites/ConsumersStandards/1_standards.html#section1_.2022
[51]	P. Zhao, S. Zhang, X. Shi, Chin. J. Med. Instrum. 45 (2021) 205-209.
[52]	National Medical Products Administration, Announcement of National Med- ical Products Administration on the Registration of Medical Device Mas- ter Files (No. 36, 2021). https://www.nmpa.gov.cn/zhuanti/ypqxgg/ggzhcfg/20210312150925118.html,March12,2021.
[53]	J. Zhang, Y. Jiang, Z. Shang, B. Zhao, M. Jiao, W. Liu, M. Cheng, B. Zhai, Y. Guo, B. Liu, X. Shi, B. Ma, Bioact. Mater. 6 (2021) 4027-4052.
[54]	J. Yang, Y. Kang, W. Zhao, J. Jiang, Y. Jiang, B. Zhao, M. Jiao, B. Yuan, J. Zhao, B. Ma, Bioact. Mater. 10 (2022) 474-491.
[55]	J. Zhang, Z. Shang, Y. Jiang, K. Zhang, X. Li, M. Ma, Y. Li, B. Ma, Regen Biomater 8 (2021) rbaa047.
[56]	J.H. Peck, D.C. Sing, S. Nagaraja, D.G. Peck, J.C. Lotz, A.E. Dmitriev, J. Biomech. 54 (2017) 26-32. DOI URL
[57]	J.H. Peck, K.D. Kavlock, B.L. Showalter, B.M. Ferrell, D.G. Peck, A.E. Dmitriev, J. Biomech. 78 (2018) 87-93. DOI URL
[58]	J.H. Peck, E. Cadel, V. Palepu, B.M. Ferrell, C.H. Warner, Mech. J. Biomech. 125 (2021) 110551.
[59]	K. Zhang, B. Ma, K. Hu, B. Yuan, X. Sun, X. Song, Z. Tang, H. Lin, X. Zhu, Y. Zheng, A.J. García, A.G. Mikos, J.M. Anderson, X. Zhang, Bioact. Mater. 15 (2022) 495-503. DOI PMID