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.
FDA is requiring certain labeling, sterilization validation, and biocompatibility assessments for identified health risks, such as adverse tissue reaction, infection, and reflux or renal damage.
United StatesFood, Drugs, Healthcare, Life Sciences
In the April 6, 2015, Federal
Register, FDA announced the reclassification of
the urethral insert with pump for bladder drainage into Class II
(special controls). FDA is requiring certain labeling,
sterilization validation, and biocompatibility assessments for
identified health risks, such as adverse tissue reaction,
infection, and reflux or renal damage.
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.
