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2018 Slow For Advertising Enforcement – But Don’t Get Complacent

 
• By Elizabeth Orr

US FDA issued only one warning letter directly related to medical device advertising or promotion in 2018. But that doesn’t necessarily mean the agency has eased up on the area, according to attorneys Seth Ray and Alan Minsk.

Don’t think US FDA isn’t monitoring device advertising and promotion just because it’s taking fewer public enforcement actions, Arnall Golden Gregory attorneys said during a recent webinar.

Only one device company got a warning letter for advertising or promotion in 2018, Seth Ray and Alan Minsk said. FDA issued eight letters total in that area across all medical product centers. That’s part of a five-year slide in the number of promotion-related letters issued by FDA

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