PerkinElmer Health Sciences, Inc. – FDA Warning Letter, Jan 13, 2017

The FDA issued a Warning Letter to PerkinElmer Health Sciences, Inc. after discovering the firm was marketing its Dried Blood Spot Card in the U.S. without proper marketing clearance or approval. An FDA review of the firm's website and a June 2013 letter revealed that the device, originally cleared under k121864 for newborn screening, was being marketed for maternal screening. This constitutes a major change in intended use under 21 CFR 807.81(a)(3)(ii), requiring a new premarket notification. Consequently, the Dried Blood Spot Card is deemed adulterated under section 501(f)(1)(B) of the Act for lacking an approved PMA or IDE, and misbranded under section 502(o) of the Act for being introduced into interstate commerce with major intended use changes without a new 510(k) submission. PerkinElmer is required to immediately cease activities leading to the device's misbranding or adulteration and submit a written response within 15 business days detailing corrective actions, prevention plans, and a timetable. Failure to comply may result in regulatory actions including seizure, injunction, civil money penalties, and impact on federal contracts.