The US Food and Drug Administration has finalized the framework for transitioning medical devices previously granted emergency use authorization or subject to particular enforcement policies to obtaining permanent marketing...more
FDA’s proposed adoption of an IMDRF document raises questions.
On October 14, the US Food and Drug Administration (FDA or the Agency) releaseda new draft guidance document, Software as a Medical Device (SaMD): Clinical...more
The Draft Guidance may not significantly increase the number of 510(k)s filed, but likely would increase manufacturers’ procedural and documentation burdens.
The US Food and Drug Administration (FDA or the Agency) issued...more
The two draft guidance documents are intended to streamline the review of next generation sequencing-based tests.
On July 8, the US Food and Drug Administration (FDA or Agency) issued two draft guidance documents...more
FDA emphasizes interoperability and outlines other best practices for effectively using EHR data in FDA-regulated studies.
Acknowledging the increased use of electronic health records (EHRs) in clinical studies, and the...more
3D printing raises significant technical considerations for device manufacturers.
In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or...more
New guidance could present liability concerns for device manufacturers.
On December 31, 2015, the Food and Drug Administration (FDA or Agency) issued a Draft Guidance for Industry titled “Public Notification of Emerging...more
The new Draft Guidance is one of a string of recent actions taken by FDA to address overall medical device cybersecurity.
Recognizing the growing importance of cybersecurity for medical devices and the potential public...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