Agency establishes a risk-based framework for assessment of postmarket cybersecurity risks for medical devices.
On December 28, 2016, FDA issued a final guidance titled “Postmarket Management of Cybersecurity in Medical...more
The Agency shows no signs of slowing regulatory activity.
Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it...more
9/1/2016
/ Advisory Committee ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Trials ,
Diagnostic Tests ,
Enforcement Actions ,
Final Guidance ,
Food and Drug Administration (FDA) ,
General Wellness Devices ,
Investigational Device Exemptions ,
Medicaid ,
Medical Devices ,
Medicare ,
Patient-Specific ,
Provider Payments ,
Unique Device Identifiers ,
Validity
The final guidance confirms FDA’s enforcement discretion for many fitness and wellness technologies but raises issues for certain testing services.
On July 29, the US Food and Drug Administration (FDA) announced the...more
The guidance documents relate to human factors testing, data, and clinical considerations.
The US Food and Drug Administration (FDA or the Agency) had a busy month in February with respect to human factors, issuing three...more
On October 15, the U.S. Food and Drug Administration (FDA) issued the final guidance “Distinguishing Medical Device Recalls from Medical Device Enhancements.” This guidance revises and finalizes the draft version that...more
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
Agency expands enforcement discretion, focusing its oversight on a discrete subset of mobile apps that present the greatest risk to patients.
On September 23, the U.S. Food and Drug Administration (FDA or the Agency)...more