If your company produces medical or health-related products, you need to know whether they meet the FDA’s definition of Class I medical devices—and, if so, you need to start now to implement UDI Rule requirements before enforcement begins on September 24.
The FDA has extended by two years key requirements related to its new unique device identifiers (UDI)—a move that amounts to a tacit acknowledgement that adoption and implementation of that tracking system for medical devices is more challenging than originally anticipated, according to the Association for the Advancement of Medical Instrumentation.
On 24x7 we have a poll to see what technology you use to eliminate or reduce manual data entry and/or the use of paper scratch sheets to log PMs or repair documentation. We offer three different choices, such as some type of Wi-FI enabled
If your company produces medical or health-related products, you need to know whether they meet the FDA’s definition of Class I medical devices—and, if so, you need to start now to implement UDI Rule requirements before enforcement begins on September 24.