Medical device manufacturers and distributors have come under increasing scrutiny from state licensing agencies and operating without a required license may lead to severe consequences. These can include financial penalties;...more
The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers and distributors. Although the NABP does not directly regulate the...more
On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more
1/15/2025
/ Artificial Intelligence ,
Cybersecurity ,
Data Management ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Regulatory Requirements ,
Risk Assessment ,
Risk Management ,
Software
U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product...more
1/14/2025
/ Artificial Intelligence ,
Clinical Trials ,
Data Collection ,
Data Privacy ,
Food and Drug Administration (FDA) ,
Machine Learning ,
Medical Devices ,
Pharmaceutical Industry ,
Popular ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management
On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020. This action comes as the latest in a series of agency responses to the coronavirus (COVID-19) outbreaks in foreign...more
3/11/2020
/ China ,
Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Imports ,
Infectious Diseases ,
Inspections ,
Manufacturers ,
Pharmaceutical Industry ,
Policy Statement ,
Public Health ,
Risk Management ,
Screening Procedures ,
Supply Chain
On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's regulatory approach to medical...more
With the continued explosion of software and software-controlled medical devices, including the growing use of machine learning and artificial intelligence, the FDA (the Agency) Medical Device Safety Action Plan (the Plan)...more
4/26/2018
/ Connected Items ,
Cybersecurity ,
Data Breach ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Patient Safety ,
Personal Data ,
Pharmaceutical Industry ,
Popular ,
Regulatory Standards ,
Risk Management
From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections also leave devices vulnerable to an...more
1/17/2018
/ Connected Items ,
Cyber Threats ,
Cybersecurity ,
Food and Drug Administration (FDA) ,
Hackers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medical Devices ,
Patient Safety ,
Personal Data ,
Pharmaceutical Industry ,
PHI ,
Privacy Concerns ,
Risk Assessment ,
Risk Management ,
Software ,
Vulnerability Assessments