Biomedical subjects
Publications and source records attributed to Maria E Donawa.
The Food and Drug Administration's final guidance document on the type of quality system information that should be submitted in some types of premarket submissions was published in February 2003. The final guidance replaces previous draft guidance. This article discusses the final guidance document.
Under the In Vitro Diagnostic (IVD) Directive, a manufacturer of IVD medical devices located outside the European Economic Area must designate an Authorized Representative before placing those products on the European market. This article discusses the responsibilities of Authorized Representatives under the IVD Directive and some of the important differences of the role as it is defined in the Medical Device Directive.
Imagine having one document that would demostrate the conformity of a medical device with regualtory requirements worldwide. Although it may be some time before this goal is reached, the United States Food and Drug Administration is launching a premarket review pilot programme in support of global harmonisation. This article discusses the programme and why European manufacturers should consider participating.
In less than 20 months, companies will only be allowed to place in vitro diagnostic (IVD) medical devices on the European market if they bear the CE mark. For this reason, the process of ensuring compliance with CE-marking requirements on or before the end of the transition period, if not already begun, should be initiated immediately. This article discusses important compliance issues.
Medical device manufacturers marketing their products in Italy, or planning to do so, need to be aware of any national requirements such as those concerning the registration of manufacturers and devices and language requirements that may apply to their products. This article provides an update on the implementation of the European Directives for medical devices in Italy.