The FDA’s Unique Identification program directs that class II device-makers to be compliant with the law by September 24, 2016. Based on this deadline, there is evidence that many manufacturers are unprepared for the next phase of the agency’s UDI rule.
A recent USDM Life Services/Loftware survey of 120 device industry professionals illustrates the level of unpreparedness. According to the survey 85% (102 respondents) indicate they are not ready for the September deadline. Another 36% (43 people) indicate their biggest challenge is understanding and apply the agency’s regulations.
According to Linda Sigg, FDA associate director for informatics and head of the agency’s UDI program, the FDA has developed and shared many resources. Unfortunately, some companies have not taken advantage of the resources.
Here is a list of 5 FDA tips to help:
- Follow the step-by-step instructions for submitting data to FDA’s Global Unique Device Identification Database (GUDID).
- Verify your data before it is published in GUDID.
- Think about how you ensure accurate data at every stage in your internal GUDID data submission process.
- At the end of the data submission process to GUDID, download your data and look at it from different angles to assess data quality.
- Communicate with your customers and business partners about UDI implementation. Labelers can benefit from thinking about how UDI implementation can help their business processes, and importantly, how UDI will work best for health-care systems and device users, such as health-care providers and patients.
Source: Linda Sigg, FDA
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