Strategic Retreat By The FDA

K&L Gates attorneys Suzan Onel and Jacqueline J. Chan look at series of four guidance documents released by the  Food and Drug Administration over a recent three-week period. All four relate to policies toward low risk devices and reflect a statutorily mandated commitment to balance the need for medical device oversight against the safety profile of the device. Calling it welcome news, the K&L Gates attorneys say these guidances demonstrate the FDA’s intent “to implement a more closely calibrated risk-based approach to general wellness products, device accessories, medical device data systems, and related medical image storage and communication devices.”