Medical Devices: Definition, Classification, and Regulatory Implications

Author:

Aronson Jeffrey K.ORCID,Heneghan Carl,Ferner Robin E.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Toxicology

Reference38 articles.

1. World Health Organization. 2019. Medical devices. https://www.who.int/medical_devices/full_deffinition/en. Accessed 21 Oct 2019.

2. Aronson JK, Ferner RE. Clarification of terminology in drug safety. Drug Saf. 2005;28(10):851–70.

3. Aronson JK. Defining “nutraceuticals”: neither nutritious nor pharmaceutical. Br J Clin Pharmacol. 2017;83(1):8–19.

4. US Food and Drug Administration. 2019. Product classification: coronary drug-eluting stents. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=1030. Accessed 21 Oct 2019.

5. Regulatory Information Task Force. Japan Pharmaceutical Manufacturers Association. Pharmaceutical administration and regulations in Japan. 2015. http://www.jpma.or.jp/about/issue/gratis/index2.html (Japanese). http://www.jpma.or.jp/english/parj/whole.html (English). Accessed 21 Oct 2019.

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