The US Food and Drug Administration’s recent policy, issued in part due to the coronavirus (COVID-19) pandemic, also suspends enforcement of Direct Marking requirements for certain Class I, Class II, Class III, and...more
The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more
3/13/2020
/ China ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Crisis Management ,
Diagnostic Tests ,
FDA Approval ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Inspections ,
Life Sciences ,
Marketing ,
Medical Devices ,
New Guidance ,
Personal Protective Equipment ,
Pharmaceutical Distribution ,
Pharmaceutical Industry ,
Premarket Approval Applications ,
Public Health ,
Supply Chain ,
Warning Letters
Health app developers must be vigilant not only of federal laws, but of state laws as well.
On March 23, New York Attorney General Eric T. Schneiderman announced a settlement with developers of three health-related...more
As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more
7/27/2015
/ Biotechnology ,
Digital Health ,
Electronic Medical Records ,
FCC ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Healthcare ,
Hospitals ,
Marketing ,
Medical Devices ,
Patient-Specific ,
Premarket Approval Applications ,
Software Developers ,
State Regulators ,
Sunshine Act ,
Telemedicine
In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more