Late last year, the Food and Drug Administration’s (FDA’s) Device Center announced a new objective when it comes to devices – “ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and...more
On January 7, 2019 the U.S. Food and Drug Administration (“FDA”) issued three new documents related to the Agency’s Software Precertification (“Pre-Cert”) Pilot Program. These documents include (1) the Developing a Software...more
1/23/2019
/ Comment Period ,
Cybersecurity ,
Digital Health ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Mobile Medical Applications ,
Popular ,
PreCert Pilot Program ,
Precertification ,
Public Comment ,
Software ,
Telemedicine
A Summary of Final Guidances for Communications That Are Consistent with FDA-Required Labeling and Communications with Payors -
On June 12, 2018, the Food and Drug Administration (FDA or Agency) finalized two draft...more
6/21/2018
/ Final Guidance ,
First Amendment ,
Food and Drug Administration (FDA) ,
HCEI ,
Labeling ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Off-Label Use ,
Pharmaceutical Industry ,
Prescription Drugs ,
Required Communications ,
Safe Harbors
Program Has Broad Reach -
On October 21, 2016, the Food and Drug Administration launched a webpage that contains an Allegations of Regulatory Misconduct Form to enable whistleblowers, competitors, and others to report...more
The Food and Drug Administration Safety Innovation Act of 2012 (“FDASIA”) required a collaborative effort by the Food and Drug Administration (“FDA”), Federal Communications Commission and Office of the National Coordinator...more