Overhaul US licensing process for devices, urges Institute of Medicine

BMJ 2011; 343 doi: (Published 02 August 2011) Cite this as: BMJ 2011;343:d4990
  1. Deborah Cohen
  1. 1BMJ

The US Food and Drug Administration needs to overhaul the process by which medium risk devices such as hip implants and x ray machines reach the market, an Institute of Medicine report has concluded.

The so called “510(k)” process, introduced by Congress in 1976 when regulation of medical devices began, is one of two regulatory pathways through which medical devices reach the market in the United States.

It requires manufacturers only to show that their product is “substantially equivalent” to another. Currently companies do not have to prove the safety and effectiveness of their product in clinical studies.

Thousands …

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