PARADIGM SHIFT OR
SAME-OLD-SAME-OLD?
THE ADVANCING LANDSCAPE
OF MEDICAL DEVICE
SUBMISSION EXEMPTIONS
50-STATE SURVEY OF DESIGN
DEFECT REQUIREMENTS
VOL. 11 NO. 4
2018
DEAR CLIENT,
Fall has descended upon us, along with that nip in the
air and the aroma of pumpkin spice. All of these herald
our latest edition of Pro Te: Solutio, which contains three
fascinating articles on topics of current interest i n our field.
In Paradigm Shift or Same-Old-Same-Old?, we look at
the New Jersey Supreme Court’s recent decision in In
Re: Accutane and how it may affect the courts’ review of
expert medical testimony going fo rward in New Jersey.
Then, in The Advancing Landscape of Medical Device
Submission Exemptions, we address the recent changes
in laws and regulations that signal a movement toward
expand ing 510( k) exemptio ns for Cl ass II d evices.
Lastly, in 50-State Survey of Design Defect Requirements,
we surveyed state laws to determine which states had
adopted the “risk-utility” test and which remained
committed to the “consumer expectat ions” test.
– PRO TE: SOLUTIO EDITORIAL BOARD
BRENDA C.
JONES
THOMAS E.
WILLIAMS
MARK A.
DREHER
JOSHUA J.
WIENER
CAROLINE L.
ELEY
ELIZABETH
E. CHANCE
CHRISTOPHER
D. MORRIS
EDITORIAL BOARD
12
