The U.S. Food and Drug Administration (FDA), based upon statutory revisions as a result of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, is implementing a certification for medical devices not exported from the United States. If certain requirements are met, a Certificate for Device Not Exported from the United States (CDNE) may be issued upon request.
A CDNE is a document prepared by the FDA that may be issued for medical devices that are manufactured outside of the United States (OUS) and are shipped to another OUS country.
A Certificate for Device Not Exported from the United States (CDNE) may be issued for medical devices manufactured outside of the United States that are:
Types of medical software (Overview)
Improper Authentication (when an actor claims to have a given identity, the software does not prove or insufficiently proves that the claim is correct) was identified as vulnerability.
The affected products are vulnerable to a network session authentication vulnerability within the authentication process between specified versions of the BD Alaris PC Unit and the BD Alaris Systems Manager. If exploited, an attacker could perform a denial-of-service attack on the BD Alaris PC Unit by modifying the configuration headers of data in transit. A denial-of-service attack could lead to a drop in the wireless capability of the BD Alaris PC Unit, resulting in manual operation of the PC Unit.
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