We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.
Results 1 to 5 of 5
Most popular |Most recent


FDA Proposes Rule on Combination Product Jurisdiction

USA - May 22 2018 On Tuesday, May 15, 2018, the U.S. Food and Drug Administration (FDA) published a proposed rule to amend its regulations concerning how medical...

Nancy K. Stade.


U.S. Food and Drug Administration Issues Final Guidance On Changes Related to Cleared Medical Device

USA - November 8 2017 After one false start, congressional intervention, a report to Congress and a relatively short interval between draft and final version of the...

Nancy K. Stade, Allison Fulton.


FDA Considers Removing Regulatory Obstacles to Generic Drug Competition

USA - August 1 2017 On July 18, 2017, the Food and Drug Administration (FDA) held a public meeting1 to obtain input on steps it can take to encourage innovation in drug...

Coleen Klasmeier, Torrey Cope.


FDA Takes Unusual Move of Proposing Regulatory Framework for LDTs in Discussion Paper

USA - January 23 2017 In an unusual move, the U.S. Food and Drug Administration (FDA) published a discussion paper on January 13, 2017, entitled "Discussion Paper on...

Nancy K. Stade, Allison Fulton.


New Guidance Reflects Heightened FDA Focus on Medical Device Cybersecurity

USA - January 26 2016 On January 15, 2016, the Food and Drug Administration (FDA) issued new guidance that, for the first time, recommends routine postmarketing...

Coleen Klasmeier, Nancy K. Stade, Anna L.Spencer, Torrey Cope.