Forbes1mon
Are The FDA’s New Regulations On Medical Devices Making A Difference?
In 2023, the Food and Drug Administration (FDA) took a more active approach to medical device cybersecurity. They issued new requirements for premarket submission and ongoing monitoring by medical ...
Medical Design and Outsourcing20h
FDA’s Tarver pushes for mandatory medical device shortage reporting
The FDA is urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the ...
JD Supra7d
FDA Publishes Guidance on Medical Device Shortages During Public Health Emergencies
Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal ...
Becker's Hospital Review2h
FDA's plan to tackle medical device shortages: 4 notes
To address these shortages, the FDA has put measures into place, including expedited review processes and the use of enforcement discretion. The FDA also now requires manufacturers to give at least ...
MassDevice23h
Trump is back: Here’s what his initial actions mean for medtech
President Donald Trump has swiftly announced a series of executive orders that could impact the medech industry.
New FDA rules to cut racial bias in some, but not all, devices to measure oxygen in the blood
At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...
FierceBiotech5d
FDA's device chief calls for more authority to address supply chain shortages impacting pediatric, neonatal patients
While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...
Forbes1y
Medical Device Security Is A Top Challenge For Healthcare CIO
Food and Drug Administration (FDA) regulations mandate that all medical device vendors tighten their security features with processes to find and mitigate vulnerabilities. The FDA mandate is a ...
FDA 510(K) Approved Facilities: Increasing GMP Inspections And Compliance Requirements
Indian medical device manufacturers are enhancing GMP compliance and embracing proactive strategies to meet rising USFDA inspections and global healthcare standards, driven by geopolitical shifts and ...
Plastics News4d
FDA warns Hologic to do more to prevent harm from component in recalled implant markers
The U.S. Food and Drug Administration has sent a warning letter to Marlborough, Mass.-based medical technology company ...