Good news for the international medical device industry. The FDA is implementing a staff training scheme for all new medical device reviewers.
The ultimate aim of this scheme is to ‘improve the consistency of medical device reviews’; this has got to be good news for device manufacturers involved in the 510(k) process. Inconsistency has often been the industry’s experience thus far and any initiatives to tackle this issue will be welcomed by organisations all over the world and the healthcare sector in the States which oozes a cutting edge and innovative ethos.
In order to be belt and braces about a consistent approach to the 510(k) process, perhaps the scheme should be made compulsory for existing staff as well as new. You can read more about it by clicking here.
Its a very good news and it is very much required in the medical sector. Training is the part of any process which makes it very effective returns into a productive and qualitative output.