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Smith & Nephew Inc.

Division of Smith & Nephew PLC

Latest From Smith & Nephew Inc.

US FDA Works To Finalize 3D Printing Guidance; Industry Asks For More

A top FDA device official says the agency is hoping to finalize an additive manufacturing guidance this year. Industry is particularly interested in seeing the leap-frog guidance made final, but would also like to see more clarification and a separate guidance to address the topic of patient-specific manufacturing.

Manufacturing Medical Device

Warning Letter Close-Outs – December 2016

US FDA released five device-related close-out letters in December.

Device Warning Letters Policy & Regulation

Compilation: 2015 Medical Device Warning Letters

Complete list of all 91 FDA device-related warning letters released by the agency last year. The upshot: 73 domestic and 18 foreign manufacturers were sent letters.

Medical Device Regulation

Warning Letter Roundup & Recap – May 5, 2015

Smith & Nephew places hold on shipments of Truclear Ultra Reciprocating Morcellators while the firm further investigates problems with the device; maker of medical support stockings didn't evaluate suppliers of fabric, yarn and thread; and more. Three device warning letters were listed by FDA this week.

Medical Device Regulation
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  • Smith & Nephew Inc.
    Phone: (901) 396-2121
    1450 Brooks Rd.
    Memphis, TN 38116