Use and recognition of consensus standards in US premarket submissions.

In the autumn of 1997, the United States Center for Devices and Radiological Health published a draft guidance document on the use of IEC 60,601 standards in the evaluation of pre-market submissions for electromedical devices. One year later, an important legislative reform act caused this draft to be withdrawn because it allowed the Food and Drug Administration (FDA) to formally recognize standards covering all types of medical devices and not just those related to electrical products. This article discusses the benefits to manufacturers of this new FDA policy and the associated guidance documents that FDA has made available.