Each year the US FDA approves about 400 implanted medical devices – generally the most risky ones – without clinical studies. Instead they use the well-trodden, less costly route, of substantial equivalence for gaining approval. Equivalence allows approval based on a summary of the evidence and presenting the similarity to devices already on the market – known as the predicate device.
A recent study published in JAMA internal medicine, looked at the US FDA database for cardiovascular, dental, general and plastic surgery, neurological, and orthopaedic devices and assessed the availability of the evidence for the device and the predicates, which is supposed to be freely available.
What they found is that data to support the claim of substantial equivalence was only available for 8 of the 50 (16%) devices. For the predicates it gets even worse, only 31 of the 1105 (31%) devices they looked at could they find any evidence. Most of the evidence they located was non-clinical data.
Their conclusions are quite damming of the current system:
‘Despite the legal requirement that scientific evidence of substantial equivalence be publicly available for medical devices cleared by the FDA through the 501(k) process, such information is lacking for most implanted medical devices cleared between 2008 and 2012, as well as for their predicates.’
Although this situation tells us about the current dire status of the US system; in the EU it is no better, as there is no publically available data.