Are The FDA’s New Regulations On Medical Devices Making A Difference?
With the FDA's new requirements for premarket submission and ongoing monitoring by medical device manufacturers in place, ...
JD Supra3d
FDA Sued Over Laboratory Developed Tests Final Rule
The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed ...
Strong Growth In The Indian MedTech Industry And Global Recognition Of FDA 510(K)
Explore the rapid growth of the Indian MedTech industry and the importance of FDA 510(k) clearance for global expansion.
US FDA Inspection on Rise: Indian Pharma and Medical Devices Manufacturers Strengthen GMP Compliance
In a significant step toward ensuring global quality standards, Indian pharmaceutical, nutraceutical, and medical device ...
theregreview6d
Evolving Regulatory Protections for Research Participants
In a conversation with The Regulatory Review, Ropes & Gray partner David Peloquin discusses how clinical research studies are ...
Med Device Online1d
U.S. Deregulation During The Trump Administration: Opportunities And Challenges For The Global Medical Device Industry
The medical device sector faces significant changes, as both Donald Trump and Robert F. Kennedy Jr. have identified the FDA ...
medtechdive1d
Few medical devices are designed for children. An FDA-Children’s National collaboration aims to change that.
Kolaleh Eskandanian, chief innovation officer at Children’s National Hospital, said the partnership is meant to address the ...
JD Supra4d
FDA's Digital Health Advisory Committee Discusses Total Product Lifecycle Considerations for GenAI-Enabled Devices
While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and ...
Forbes24d
How Medical Device Cybersecurity Evolved From Idea To Industry Imperative
The FDA’s new requirements represent a fundamental shift in the regulatory landscape for medical device manufacturers (MDMs), as cybersecurity is now a non-negotiable element of device ...
medtechintelligence1d
How will deregulation in the US affect the international medical device market?
The United States is currently under the spotlight as Donald Trump’s recent appointment and consequent nomination of Robert F ...
Health Affairs22d
FDA Breakthrough Device Designation: Clinical Evidence And Medicare Payment Policies
While FDA evaluation of medical devices is based on “reasonable ... have undergone post-approval clinical studies. Without CMS’s requirements or incentivization to conduct clinical utility ...
Med Device Online2d
5 Reasons Why 2025 Is The Year Pharma Companies Will Revisit Their Drug Delivery Device Strategies
One could be forgiven for feeling the same way about the current world of drug delivery devices, with an increasingly ...