In the editorial S. Mishra1 raised an important topic, the regulatory approval process of the medical devices. Medical devices are the cornerstone for the development in medicine. Currently there are two main regulatory bodies, the FDA in the USA and the CE mark in Europe. The FDA approval process is reliable but complicated and lengthy, and on the other hand the CE mark is less reliable but faster and simpler. We would need a standardized, regulatory process that combines the best of these two, simple, fast and reliable. It is a challenge and duty of the medical community, the manufacturers and the regulatory bodies to create such a regulatory process. Unfortunately, until that comes we have to live with what we have. Making life simple, this should be the message.
Conflict of interest
The author declare no conflict of interest.
Funding
The author declare no funding.
Reference
- 1.Mishra S. FDA, CE mark or something else?-thinking fast and slow. Indian Heart J. 2017;69:1–5. doi: 10.1016/j.ihj.2016.11.327. [DOI] [PMC free article] [PubMed] [Google Scholar]