The FDA has released enhanced recommendations on the production and disinfection of reusable medical devices, according to a press release.
Targeted at device manufacturers, the documentation includes guidelines on the labeling of these products and an explanation of six criteria taken into account by the FDA when approving new reusable medical devices. The agency advices industry members to consider these recommendations early in the development of new products.
The industry guidance document is available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM253010.pdf.
FDA Releases Approval Guidelines for Reusable Medical Devices
