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Posts from the ‘FDA’ Category

Mobile Medical Applications: FDA Guidance is Out!

The FDA finally issued a guidance for industry and FDA staff about mobile medical applications. I think they meant medical mobile applications, but still. The point is they are moving forward. Here is the PDF.

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The FDA Launches The Patient Network to Educate Patients

It was time for the FDA to step up and represent the very loud voice of e-patients as well. The FDA Patient Network was just launched to educate patients and advocates about FDA; recruit patients and advocates to serve in meetings and to speak at FDA events; and ensure that patients and advocates can express their concerns about FDA decisions. It’s a good first step.

We are the Patient Network, a part of the FDA. We work to bring the unique perspective of patients, family members, caregivers, and patient advocates to the decision-making processes of the FDA. Through the Patient Network, you can learn more about FDA and how it works, provide input in decisions about new or current medical products, and talk with FDA experts about issues and concerns that are important to you.

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A guide to the FDA for digital health entrepreneur: Slideshow

Rock Health published a slideshow about a guide to the FDA for digital entrepreneurs.

Mobile Apps Regulated by FDA

FDA has published an announcement about regulations regarding medical mobile applications.

The agency’s draft guidance defines a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices. This subset includes mobile medical apps that:

a. are used as an accessory to medical device already regulated by the FDA
(For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet); or

b. transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices
(For example, an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack).

Fortunately, some specific apps won’t be regulated:

  • “that are electronic “copies” of medical textbooks, teaching aids or reference materials
  • “that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness.
  • “that only automate general office operations with functionalities that includebilling, inventory, appointments, or insurance transactions.
  • “that are generic aids that assist users but are not commercially marketed for a specific medical indication”

FDA launches consumer-friendly Web search for consumers during recalls

Here is an interesting press release from FDA:

Beginning today, consumers can search for food and other product recalls easier and quicker on FDA’s website than previously. The FDA Food Safety Modernization Act (FSMA) signed into law in January by President Obama called for a more consumer-friendly recall search engine.

To provide greater ease of use for consumers, the search results provide data from news releases and other recall announcements in the form of a table. That table organizes information from news releases on recalls since 2009 by date, product brand name, product description, reason for the recall and the recalling firm.

For more information:

Personalized Genetics: FDA, DTC and GINA

Here are some interesting news and announcements to keep you absolutely up-to-date regarding the improvements of personalized medicine.

There are a number of reasons why DTC genetic testing may soon find itself subject to increased federal regulatory oversight. However, 23andMe’s widely publicized data error should not be one of those reasons. In fact, the sample swap, while unfortunately timed, actually presents a compelling argument in favor of the direct-to-consumer model for genetic testing.

A personalized medicine study from the Coriell Institute for Medical Research suggests that patients who undergo genetic testing are more likely to change their personal habits, writes Emily Singer at the Technology Review Editors’ blog.

Stanford University School of Medicine today said that it will offer a new course that gives medical and graduate students an option to study their personal genotype data. The university said that it believes it is the first medical school to offer students such a course. However, the University of Pennsylvania School of Medicine offered its fourth-year medical students a similar course in personalized medicine this past year.

FDA in Social Media: Second Life Event

You have probably heard about the Food and Drug Administration Social Media Hearing that took place last November focusing on how FDA-regulated products should use internet and social media for health-related communications. It also has an own, properly designed, online presence including Twitter streams and partners.

A week ago, I had a chance to attend a lively discussion focusing on this issue in the virtual realm of Second Life moderated by Patricia F. Anderson. I’ve seen numerous conferences in Second Life and this one was again a nice example that virtual environment is still useful when people from around the world would like to gather around and watch a presentation, then discuss it.

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