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Home » Consulting attorney: Breakthrough device program not all about speed
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Consulting attorney: Breakthrough device program not all about speed

May 19, 2021
By Mark McCarty
The FDA’s breakthrough devices program encodes a number of policy objectives for the agency, but industry might see the program principally as a vector for faster time to market. However, Janice Hogan, partner at Hogan Lovells US LLP, said device makers might want to consider that the greater benefit is reducing regulatory uncertainty, not beating the typical FDA review clock.
BioWorld MedTech Regulatory U.S. FDA

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