submitted by healthnews 478 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 493 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 454 days ago (via edocket.access.gpo.gov)
This draft guidance document updates and clarifies the procedures for reviewing premarket notification submissions (510(k)s) for devices labeled as sterile, particularly with respect to sterilization technologies FDA considers novel, and the information..
submitted by healthnews 505 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 462 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 487 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...
