submitted by healthnews 652 days ago (via edocket.access.gpo.gov)
The FDA is announcing the availability of proposed and final documents that have been prepared by Study Group 1 of the Global Harmonization Task Force (GHTF).
submitted by healthnews 667 days ago (via accessdata.fda.gov)
The committee will discuss and make recommendations on the premarket notification application for the Fujirebio HE4 EIA kit and associated Risk of Malignancy algorithm (ROMATM) Test. The HE4 EIA is an enzyme immunometric assay for the quantitative de...
submitted by healthnews 679 days ago (via edocket.access.gpo.gov)
FDA is implementing electronic data collection to improve adverse event reporting across the agency. FDA's current processes and systems for adverse event reporting vary across its centers and are not optimal for the efficient collection of voluntary...
submitted by healthnews 149 days ago (via edocket.access.gpo.gov)
The FDA is proposing to amend certain neurological device and physical medicine device regulations to establish special controls for these class II devices and to exempt some of these devices from the premarket notification requirements of the Federal...
submitted by healthnews 636 days ago (via accessdata.fda.gov)
The committee will discuss, make recommendations and vote on a premarket approval application, sponsored by Emphasys Medical Inc., for the Emphasys Zephyr Endobronchial Valve System, which is intended to improve Forced Expiratory Volume in the first ...
submitted by healthnews 661 days ago (via fda.gov)
The FDA is amending the classification regulation for condoms to designate a special control for male condoms made of natural rubber latex (latex). The...
submitted by healthnews 147 days ago (via fda.gov)
Les Weinstein was appointed as the first CDRH Ombudsman in 2000. As a primarily external Ombudsman, he looks into complaints from outside the agency and facilitates the resolution of disputes between CDRH and the medical device industry it regulates...
