FDA moves forward on UDI regs; Class II must comply by fall

The U.S. Food and Drug Administration will move forward on unique device identifiers (UDI) this fall, requiring that Class II medical devices comply with regulations by Sept. 24, the Regulatory Affairs Professionals Society (RAPS) reports.

Class I and non-classified devices also will be required to meet the regulations, but not until 2018, the FDA announced in Baltimore on Monday during UDI Conference 2016. The regulations require that device makers submit identifiers to the FDA's Global Unique Device Identifier Database (GUDID) by the aforementioned dates.

The UDI rule began to take effect in 2014 when Class III devices had to meet identifier regulations. That class consists of implantable, life-supporting and life-sustaining tools.

Austin Frank, a health economist, writes at the New York Times Upshot blog that currently, the industry is not collecting the medical device data it should and that the system in place is a "passive system that's not up to the task."

Pew Charitable Trusts, in a report published last September, said unique device identifier use must be supported by both the private healthcare sector and government agencies.

The FDA is continuing to make updates to its system, including improvements to its database so it can handle the information coming in from Class II devices, Indira Konduri, GUDID program manager at FDA, tells RAPS.

He adds there will be a "DI trigger" included in the GUDID to track changes in a device's entry that would require the developer to get a new identifier. One example he gives where that would apply is if a device is made for single use, but then updated to make it multi-use.

The FDA also is working on a policy to address compliance for devices that are loaned to providers, according to the report.

To learn more:
- here's the RAPS report
- read the NYT Upshot post

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