Jones Day is a global law firm with more than 2,500 lawyers across five continents. The Firm is distinguished by a singular tradition of client service; the mutual commitment to, and the seamless collaboration of, a true partnership; formidable legal talent across multiple disciplines and jurisdictions; and shared professional values that focus on client needs.
In the October 27, 2015, Federal Register, FDA issued a final order classifying an autosomal recessive carrier screening gene mutation detection system into class II (special controls).
United StatesFood, Drugs, Healthcare, Life Sciences
In the October 27, 2015, Federal Register, FDA issued a final order
classifying an autosomal recessive carrier screening gene mutation
detection system into class II (special controls). The special
controls that apply to this device are identified in this order and
will be part of the codified language for the autosomal recessive
carrier screening gene mutation detection system classification.
The order is effective immediately.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.