The determination of whether or not a device clinical trial is required is largely based upon a FDA classification of the device, as illustrated in the table below:
|Class I||Class II||Class III|
|Requires a clinical trial?||No||Maybe(less than 10 percent of the 510(k) submissions)||Yes|
FDA may request clinical performance data (clinical trials) to support a substantial equivalence (SE) determination if:
In the U.S., clinical studies/investigations involving one or more human subjects to determine the safety or effectiveness of a device must be conducted in accordance with the Investigational Device Exemptions (IDE) regulations, 21 CFR Part 812, as applicable.
This document provides to sponsors, contract research organizations (CROs), data management centers, clinical investigators, and institutional review boards (IRBs), recommendations regarding the use of computerized systems in clinical investigations (e.g. clinical trials). This guidance supplements the guidance for industry on Part 11, Electronic Records; Electronic Signature. The computerized system applies to records in electronic form that are used to create, modify, maintain, archive, retrieve, or transmit clinical data required to be maintained, or submitted to the FDA.
This guidance provides the following recommendations regarding the use of computerized systems in clinical investigations:
Training of Personnel – Those who use computerized systems must determine that individuals (e.g., employees, contractors) who develop, maintain, or use computerized systems have the education, training and experience necessary to perform their assigned tasks (21 CFR 11.10(i)).
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Smiths Medical (Headquarters: Minneapolis, MN) is recalling specific software versions of the Medfusion 3500 and 4000 Syringe Pumps because of a software error that may lead to over-delivery or under-delivery of fluids or medication. Over- or under-delivery can occur if the following specific sequence of events occur: a bolus or loading dose is interrupted, the pump is primed, and the infusion is restarted. Use of the affected syringe pumps may cause serious adverse health consequences including death.
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