Tag:
FDA device regulation
Latest Headlines
Latest Headlines
FDA looks to regulate medical apps
The FDA has unveiled its oversight approach for certain mobile applications specific to medicine or healthcare. The moves comes as millions of smartphone users start using apps to perform a variety
FDA could toughen regs for defibrillators
The FDA is mulling stricter approval regulations for external defibrillators following dozens of recalls involving hundreds of thousands of the devices. In documents posted late last week, the agency
Obama: FDA med device changes coming today
In a Tuesday Wall Street Journal op-ed piece, President Obama announced a newly signed executive order that pushes for more efficient regulation throughout government agencies, including the FDA.
Live from AdvaMed: The do's and don'ts of FDA inspections
WASHINGTON, DC - The medical device and pharmaceutical industries are currently facing a challenging FDA enforcement environment. A number of high-profile recalls and public health issues have put
FDA plans to revamp 510(k) guidelines
The FDA has proposed new guidelines for the 510(k) process which allows devicemakers to gain accelerated approval for devices similar to those already on the market. Companies complain that the
FDA: Genetic tests are medical devices
The FDA will regulate certain types of diagnostic tests the same way the agency monitors medical devices. Genetic testing companies deCODE Genetics, Illumina, Knome, Navigenics, and 23andMe all
