December 12, 2012

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm331675.htm

This FDA Guidance Paper describes the requirements for medical devices which are mainly used by patients in their standard living environment. These so called “home use devices” have, based on their characteristics regarding the use environment and user profile, a higher potential for possible use errors and a resulting risk for the patient.

The document gives a detailed description of the use environment of these devices and lists the minimal consideration regarding the environment which should be kept in mind during the development of such devices. A major part of the document describes several possibilities to gather information regarding the end-user and refers to well-known and establishes US as well International standards of the Human Factors Engineering or Usability Engineering process.

The document also states the specific features regarding the post market surveillance of “home use devices” as well as considerations regarding the labeling of these devices.

If you have any questions or anything seems unclear regarding this article do not hesitate to contact Thore Reitz.