S. Korea regulators may rule Samsung smartphone a medical device
March 3, 2014 by Arezu Sarvestani
MASSDEVICE ON CALL — South Korean healthcare regulators are taking a closer look at Samsung’s new Galaxy S5 smartphone in order to determine whether the built-in heart rate sensor turns the phone into a medical device.
The technology giant revealed earlier this month that it would include the sensor in the new generation of its Galaxy phones and Gear smart-watches, but South Korean regulators are concerned that doctors may use the sensor for medical purposes. Read more
The blurry line between mobile app and medical device
March 7, 2014 by Arezu Sarvestani
MASSDEVICE ON CALL — Mobile app developers are growing increasingly interested in healthcare, creating something of a crisis of regulation.
The FDA last year released guidance on how it plans to regulate healthcare apps, saying generally that it plan to let developers of apps that fit in the gray area between medical technology and harmless health app to determine for themselves when to undergo agency review. The FDA asked developers to use some measure of common sense in making that decision, but the line between mobile app and regulated medical device isn’t always so clear. Read more
What’s new in the FDA’s 2015 budget?
March 7, 2014 by MassDevice
A few days ago, President Obama released his Fiscal Year 2015 Budget Message to Congress, which included a high-level summary of his proposed funding for the FDA. Today the White House is out with the full budget, complete with all of the nitty gritty details.
Although these budgetary times are difficult, the FDA received some good financial news. The president is requesting a $4.7 billion budget for FDA, an 8.1 percent increase over the 2014 budget that Congress passed earlier this year. Read more
When regulators pay for peer-review
March 4, 2014 by MassDevice
The ongoing controversy among US physicians over newly-implemented “Maintenance of Certification (MOC)” requirements created by the private organization, the American Board of Medical Specialties (ABMS) and its 24 subsidiary sub-specialty boards has breached another ethical front: paying for peer-reviewed publications in support of their expensive and proprietary MOC process.
In the Fall of 2013, the ABMS single-handedly funded an entire supplement devoted to the MOC process in the Journal of Continuing Education in the Health Professions. This journal is published quarterly by the Alliance of Continuing Education in the Health Professions, the Society for Academic Continuing Medical Education, and the Council on CME of the Association for Hospital Medical Education. Not surprisingly, the articles published were uniformly favorable about the MOC process despite evidence to the contrary. The American Medical Association (who also stands to benefit from the process politically) was quick to provide a free link to the full pdf of the supplement from its AMA Wire news bulletin. Read more
Staff changes at Indian regulator could boost review processes in the long term
March 3, 2014 by MassDevice
The Drugs Controller General of India (DCG(I)), India’s medical device and pharmaceutical market regulator, has appointed a new head of its Medical Device Division as well as a new Joint Drugs Controller, which could lead to more efficient registration processes in the country.
First, Aseem Sahu has succeeded Dr. E. Reddy as head of DCG(I)’s Medical Device Division. In addition, Dr. V. G. Somani has been named Joint Drugs Controller at the Central Drugs Standard Control Organization’s head office in New Delhi. Read more
