On October 15, the U.S. Food and Drug Administration (FDA) issued the final guidance “Distinguishing Medical Device Recalls from Medical Device Enhancements.” This guidance revises and finalizes the draft version that...more
On August 14, the Food and Drug Administration (FDA) issued a draft guidance titled “De Novo Classification Process (Evaluation of Automatic Class III Designation).” The draft provides guidance on a streamlined process for...more
On July 28, the Food and Drug Administration (FDA) issued a final guidance titled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].” Device manufacturers should be aware of key...more
FDA sends notice to Congress on LDTs.
The U.S. Food and Drug Administration (FDA) has notified Congress that it intends to issue draft guidance to propose a risk-based, phased-in framework for oversight of laboratory...more
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The draft guidance also enables some health IT manufacturers to avoid the device tax.
The Food and Drug Administration (FDA) took an unusual step on June 20 by issuing new draft guidance that states its intent to not...more
Manufacturers seeking to enter the medical food market face increased challenges.
The Food and Drug Administration (FDA or the Agency) has issued several Warning Letters to manufacturers of medical foods...more
Agency expands enforcement discretion, focusing its oversight on a discrete subset of mobile apps that present the greatest risk to patients.
On September 23, the U.S. Food and Drug Administration (FDA or the Agency)...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
FDA issues safety communication and draft guidance clarifying that manufacturers are responsible for addressing cybersecurity risks related to their medical devices....more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