Wednesday, August 15, 2012

Will FDA CDRH Soon be Reviewing Video Games? ... as medical devices

 . . . the expanding scope of medical device regulations over mobile apps, and now possibly video games:

Will CDRH Soon be Reviewing Video Games? > RAPS > News - Article View:

"Video games aren't traditionally known as medical devices. In fact, there aren't yet any approved by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH), the US's medical device regulatory body. But all that could soon be changing.

At least one company, Boston and San Francisco-based Akili Interactive Labs, is on the verge of taking a video game it has specifically tailored for the treatment of attention deficit/hyperactivity disorder (ADHD) before FDA for potential approval.

Akili's game, named "Project: Evolution,” would work on the presumption of prior research that action-oriented video games can improve a person's concentration. The advantage for the game would be the almost-total mitigation of side effects, likely giving it a highly positive risk-benefit assessment even if it doesn't prove as effective as first-line treatment for ADHD."

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FDA Looking to Overhaul Compliance Approach

FDA's proposed solution is being dubbed "The Case for Quality"—a tripartite approach consisting of a focus on quality, enhanced transparency and stakeholder engagement.

FDA Looking to Overhaul Compliance Approach > RAPS > News - Article View:

"The US Food and Drug Administration (FDA) is headed toward a marked change in compliance policy in the coming years as the result of rapidly surging imports of pharmaceutical, medical device and biologics products, according to Mark Roh, regional food and drug director for FDA's Pacific Region. Under the new system, stand-alone compliance issues would become secondary in importance to quality systems put in place by companies."

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Tuesday, August 14, 2012

FDA investigating claims of penny, plastic found in Penn State's campus ice cream

FDA investigating claims of penny, plastic found in Penn State's campus ice cream; Penn State Takes Action to Ensure Ice Cream Safety - WPMT:

"Penn State officials have sought the assistance of the Food and Drug Administration (FDA) to investigate four recent incidents involving the discovery of foreign objects in half-gallon ice cream containers sold at its campus creamery. The University also is taking steps to make its product safer on the shelf."

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Thursday, August 2, 2012

FDA Approves Swallowable Sensor That Tracks Health From The Inside

FDA Approves Swallowable Sensor That Tracks Health From The Inside:

"The US Food and Drug Administration has approved an ingestible digital sensor that can be swallowed in a pill to track health data from inside the body. The idea is that the data can be used not only by patients themselves, but also by caregivers and doctors to individualize their care.

The ingestible sensor, formerly known as the Ingestion Event Marker or IEM, is already approved for use in Europe.

It is the first "digital pill" to receive FDA approval, in a move that its maker Proteus Digital Health, whose headquarters are in Redwood City, California, sees as the start of a era where digital medicine "shifts the care paradigm"."

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