The introduction of a targeted approach to treatment of prostate cancer requires the approval of novel medical devices. Here, authors describe the regulatory pathways that govern the approval of novel medical devices for clinical use. Owing to differences in legislation, these approval pathways differ substantially between the European Union and the USA, often resulting in patients receiving different treatments for prostate cancer in Europe, compared with the USA.
- Massimo Valerio
- Mark Emberton
- Hashim U. Ahmed
