In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more
The draft guidance also enables some health IT manufacturers to avoid the device tax.
The Food and Drug Administration (FDA) took an unusual step on June 20 by issuing new draft guidance that states its intent to not...more
Device manufacturers should be aware of new issues and policy changes, which include the removal of the "two-year rule" for malfunctions.
On July 9, the U.S. Food and Drug Administration (FDA) issued a new draft...more
Pending the January 1 effective date, final regulations and interim guidance on the medical device excise tax provide some clarity but leave many questions unanswered.
On December 7, the Internal Revenue Service (IRS)...more