Tag Archives: FDA definitions

Unique Device ID Rules Issued

OperRoomThe FDA has produced its Final Rules implementing its unique device identifier to establish a consistent labeling system for devices and facilitate its postmarket surveillance plan.

Most devices will fall under the plan for which implementation will be mandated over the next 5 years.  Most Class III, high-risk medical devices must comply by September 24, 2014.  Most Class II devices, moderate-risk devices have three years and those Class I, low-risk devices have five years to comply.

The Final Rules also specify the Global Unique Device Identifier Database, the FDA’s publicly searchable database,  to which the device manufacturers submit device code information.

Click here for an article from the law firm, Baker Hostetler.

Click here to read the FDA Final Rules. 

Post by Dennis McCarthy

 Google

Mobile Apps Require FDA Review

SmartphoneAppsThe Food and Drug Adminstration, FDA, has provided final guidance to determine which mobile apps may require FDA scrutiny and regulation.

The more the mobile app’s intended used is as an integral part of the functioning of a medical device, the more likely it falls within regulatory scrutiny.  For example, a mobile app used to read the results of diagnostic tests are likely to be defined as a “mobile medical app” and, therefore, face FDA review.

At the other end of the spectrum, mobile apps that are used for normal office functions such as scheduling office visits or reminding patients about non-medical behavior such as getting sufficient exercise, are unlikely to face review.

Click on the links below or copy and paste the links into your browser to read a helpful summary of the FDA announcement by Foley & Lardner, the law firm, or the FDA guidance.

http://www.jdsupra.com/legalnews/fda-submits-final-guidance-on-mobile-med-92633/

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf
 
 By Dennis McCarthy
 Google