nick-otto-articles
-
FDA Issues Emergency Use Authorization For Ebola Diagnostic Device
10/28/2014
FDA officials recently issued an emergency use authorization (EUA) for Utah-based BioFire Defence’s FilmArray Biothreat-E test for the detection of the Ebola Zaire virus. The test runs and can only be used with the device maker’s FilmArray systems.
-
Have Medical Device Review Times Improved?
10/28/2014
A new look at the FDA’s medical device review times from the California Healthcare Institute (CHI), in partnership with The Boston Consulting Group, points to a modest improvement in the agency’s review times.
-
FDA Details Labeling Requirements For MTB-Complex Testing Devices
10/24/2014
Manufacturers of nucleic acid-based in vitro diagnostic devices used for the detection of Mycobacterium tuberculosis complex (MTB-complex) should take a variety of steps to prevent false-negative and false-positive results, according to recommendations from an FDA Class II special controls guidance.
-
Australia Proposes Domestic Device Registration Using European CE Marking
10/22/2014
Australia’s prime minister recently issued a new proposal that would allow Australian device makers to register “routine” medical devices using conformity assessment certifications acquired from European notified bodies.
-
FDA Must Follow Congressional Procedures When Rescinding 501(k) Clearance
10/1/2014
The FDA’s ability to reclassify devices was restricted by a federal appeals court, which issued a ruling that says the agency does not have the inherent authority to reclassify devices.
-
Final FDA Guidance Details Custom Device Exemptions
9/26/2014
Fresh guidance from the FDA details exemption processes to traditional approval requirements for manufacturers of custom medical devices.
-
FDA Sets Date For Cybersecurtiy Workshop
9/25/2014
The FDA is seeking public input on the cybersecurity of medical devices and has scheduled for next month a two-day public workshop in collaboration with the Department of Homeland Security.
-
NIH Issues Additional Funding To Study Gender Differences In Clinical Trials
9/24/2014
The National Institutes of Health (NIH) is investing $10 million in additional funding for scientific trials to encourage researchers to consider gender in their preclinical and clinical studies.
-
Industry Lauds Passing Of Bill To Repeal Device Tax
9/22/2014
The House of Representatives recently voted to pass a bill that would repeal the hotly debated 2.3 percent medical device excise tax.
-
FDA Proposes Reclassification of EPPG, PSA Devices To Class II
9/19/2014
The FDA is proposing to reclassify both external pacemaker pulse generator (EPPG) devices and pacing system analyzers (PSAs) as class II devices with special controls.