By Agung Purnama and Daniela Drago2019-05-01T15:59:00
The regulations, developed as a result of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1938, share a common goal with the pharmaceutical regulations: they both strive to ensure that new medical treatments reach the public as quickly as possible while protecting patients and ensuring that the new treatments have a positive benefit–risk balance. However, they approach this goal in different ways. This continuing professional development supplement explains the fundamentals of the FDA regulatory pathways for medical device manufacturers that wish to bring their products to the US market.
Register now to continue to access industry news, editorials and podcasts plus one member-only journal article each month.
Log-in now using your MyTOPRA credentials, for unlimited access to all Regulatory Rapporteur journal articles, the online archive and latest industry news and podcasts.
LoginBecome a TOPRA member and join our global regulatory affairs community
The peer-reviewed journal, published 11 times per year and available free to TOPRA members.
The Organisation for Professionals in Regulatory Affairs
TOPRA office
TOPRA Publishing, 6th Floor, 3 Harbour Exchange, South Quay, London E14 9GE, UK
Tel: +44 (0) 20 7510 2560
Email: publications@topra.org
TOPRA AISBL
Blvd du Souverain 280, 1160 Brussels, Belgium
Tel: +32 (0) 2 808 72 70
Site powered by Webvision Cloud