James Boiani Quoted in “FDA Delays UDI Date for Some Devices as It Finishes Convenience Kit Guide”

FDA Week and Inside Health Policy

James A. Boiani, a Member of the Firm, in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in FDA Week and Inside Health Policy, in “FDA Delays UDI Date for Some Devices as It Finishes Convenience Kit Guide,” by Nicholas Florko. (Read the full version – subscription required.)

Following is an excerpt:

"It shows FDA's recognition that the phase-in of the UDI requirements is more difficult for manufacturers than first believed," wrote James A. Boiani member of the firm Epstein, Becker & Green. "I don't think it's too surprising that combo products and device kit manufacturers are feeling more pain from UDIs, both due to the ubiquity of these products/kits and the fact that there are number of smaller kitters that may have fewer resources to dedicate to the phase-in."