FDA Committee Debates What ‘Mission Critical’ Devices 506J List Should Include

Rather than trying to predict which medical devices could be in short supply during a national emergency, the FDA should focus on identifying those that are “mission critical” to patient care, according to an agency advisory committee.

The General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee engaged in a far-reaching discussion Tuesday on updates to the 506J Device List. Manufacturers of these devices, which are considered indispensable during a public health emergency, must notify the FDA any time a supply chain or manufacturing issue threatens to compromise availability. As it stands, the list comprises 284 product codes for around 1,700 items distributed among 11 medical specialties. 

The panelists also considered how often the 506J list should be updated, with some suggesting weekly, others quarterly or annually.

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