US FDA and device industry experts are concerned that too many firms are woefully unprepared for, and undereducated about, the agency's Unique Device Identification program. A recent industry survey appears to bear this out: A whopping 85% of respondents say they're not ready for the upcoming UDI compliance deadline of Sept. 24 for makers of class II products. Meanwhile, firms asking for UDI exceptions for their devices are waiting an inordinate amount of time for FDA to come to a decision, in part because the agency simply doesn't know how to publicly disclose the exemptions, UDI guru Jay Crowley says. Also: experts mull over the agency's latest UDI guidance; FDA explains why using an HL7 UDI submission option for its GUDID database isn't a good idea for every firm; and Crowley discusses what the UDI landscape will look like in 2020.

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Members of the EU’s Clinical Trials Coordination Group have developed harmonized requirements for updating trials that are transitioned to the Clinical Trials Information System based on a minimum set of documents.