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The New Jersey Life Sciences Vendors Alliance (NJLSVA) is a coalition of businesses, individuals and academia who provide goods and services to New Jersey’s life sciences companies.

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FDA Clarifies Medical Device Tracking Rule with Draft Guidance

Medical Devices 4Washington, DC, July 26, 2016 ― Sarah Chacko reports in The Hill that the Food and Drug Administration (FDA) released draft guidance on Monday for identification tags that will track medical devices from manufacturers to users.

The guidelines come as the number of medical devices required to meet the tracking regulations is expected to grow this fall.

The agency is phasing in requirements for unique device identifiers (UDIs) in an effort to better track medical devices, from pacemakers to condoms.  

A UDI indicates the specific model and information on up to five production elements, such as the serial number, expiration date or date the device was manufactured.

The guidance clarifies that the UDI is required in two formats: a plain-text version and an automated version that can be added to a patient’s electronic health record or other computer system. It also sets guidelines for how the information on the UDI should be ordered.

The draft guidance will be open for comment for 60 days.

For Chacko’s full story, click here.