Regulatory News

On March 17, Virginia Governor Terry McAuliffe signed into law House Bill 1515 sponsored by Delegate David Bulova to require that hospitals and others providing maternity care give new parents information on safe sleep environments for newborns.
The US Food and Drug Administration Center for Devices and Radiological Health has released draft guidance on General Wellness: Policy for Low Risk Devices. These general wellness products include consumer sleep trackers.
Mark Rosekind, PHD, administrator for the National Highway Traffic Safety Administration (NHTSA), at US Dept. of Transportation in Washington, DC, for Sleep Review. [Image copyright Matthew Rakola]
The appointment of Mark R. Rosekind, PhD, to administrator of the National Highway Traffic Safety Administration is an opportunity to further advance drowsy driving awareness.
The Therapeutic Goods Administration (TGA) in Australia has approved the Zzoma sleep apnea device for listing on the Australian Register of Therapeutic Goods (ARTG), announced Sleep Specialists LLC, a medical device company specializing in sleep therapy.
TruckingBulletinAnalysis
In January, the Federal Motor Carrier Safety Administration issued a bulletin to medical examiners and training organizations regarding obstructive sleep apnea. A sleep physician with commercial transportation expertise weighs in.
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The Coast Guard is seeking public comment on a proposed policy clarification regarding the specific medical documentation it will consider in determining whether a medical waiver is warranted for merchant mariners with sleep disorders (among other disorders it seeks to issue clarification for).
NSF advocacy
More than 40 National Sleep Foundation (NSF) representatives spent February 11 in the halls of Congress, engaging in 55 meetings with US Senators and Representatives about important sleep advocacy areas.
US Senator Charles E. Schumer (D-NY) urges the Metropolitan Transportation Authority (MTA) to quickly expand its Metro-North sleep apnea evaluation pilot program to include Long Island Rail Road (LIRR) engineers.
drowsydrivingpodcast
In Episode 1 of Sleep Review Conversations, three sleep medicine experts share their insights on drowsy driving prevention challenges and solutions. The panelists speak to where change must start, drowsy driving in commercial transportation, prevention technologies, and societal trends.
NTSB most wanted 2015
Under the broad topic of "require medical fitness for duty," the National Transportation Safety Board (NTSB) has identified obstructive sleep apnea diagnosis and treatment as on its "most wanted list" of safety advocacy priorities for 2015.
On March 2, the Federal Aviation Administration (FAA) will issue new medical guidance to Aviation Medical Examiners (AMEs), the agency said on Friday.
FMCSA bulletin
In a bulletin issued this month by the Federal Motor Carrier Safety Administration (FMCSA), the agency reminds its certified medical examiners to use their "medical training and expertise in determining whether a driver exhibits symptoms and/or multiple risk factors for OSA [obstructive sleep apnea]."
A bipartisan group of 10 Senators, led by Senate Finance Committee Chairman Orrin Hatch (R-Utah), has introduced the Medical Device Access and Innovation Protection Act, S. 149, a bill to repeal the medical device tax that was implemented as a part of the Affordable Care Act (ACA).
Mundipharma's Targin (Targinact, Targiniq), a fixed combination of prolonged-release oxycodone/naloxone, has received a positive European Commission decision for a new indication, as a second line symptomatic treatment for patients with severe to very severe idiopathic restless legs syndrome (RLS), after failure of dopaminergic therapy.
sensor
The 2014 mHealth Summit, held in Washington, DC, on December 9, featured a panel on mobile health innovation and regulatory roadblocks.
The International Trade Commission (ITC) issued its final decision in the case brought by ResMed against BMC Medical Co Ltd/3B Medical in a notice issued December 23.
Excessive daytime sleepiness (EDS) is a well-known symptom of narcolepsy, but EDS isn't accurately described only as feeling tired during the day, people with narcolepsy say. It also includes cognitive impairments, commonly referred to as "brain fog" among narcolepsy patients.
After over 3 years, the United States Patent Office has granted Apnea Sciences a utility patent #8833374 on its microadjustment technology for its anti-snore mouthguard.
DistarAdjustableTheraSnore
On Friday, Distar's Adjustable TheraSnore received Food and Drug Administration (FDA) 510(k) clearance to treat obstructive sleep apnea. Previously, the oral appliance had FDA clearance to treat snoring.
There are several Food & Drug Administration (FDA) cleared pharmaceuticals for patients with narcolepsy, but healthcare providers should be aware that patients are also helped by non-drug therapies, such as naps, to help control symptoms (in conjunction with medication) too.