US and European systems

In the US, there are essentially two ways devices are reviewed before approval. A more rigorous process, known as premarket approval (PMA) involves reviewing evidence of clinical tests of a new device. A less stringent approach, known as the 510(k) process, is intended for the approval of devices that are similar to others already on the market. Once a device has been either approved or cleared by the Food and Drug Administration under one of these routes, it can be marketed. However, there has been growing concern that the 510(k) route involves a far lower degree of scrutiny than PMA and is being used inappropriately for some devices, and that both processes involve far less regulatory oversight than approval of new drugs.3 4 Even PMA scrutiny is not very high—typically only one or two studies are submitted, of which the majority are non-randomised, single arm studies with fewer than 100 participants.5 6

When devices fail or have faults they may be recalled. The FDA publishes a list of recalled devices and the regulatory processes they had passed through. Zuckerman and colleagues analysed 113 medical devices recalled by the FDA from 2005 to 2009 because of risks of serious health effects …