FDA Guidance on Studying and Marketing Medical Devices – Part One
The Food and Drug Administration has numerous guidance articles about premarket submissions for the developers of medical devices. We discuss steps one and two.
Artificial Intelligence Uses in The Healthcare Industry
Artificial manufacturers need to understand the FDA approval process for medical devices and drugs. Physicians need to understand AI uses and patient privacy issues.
Healthcare Compliance Issues for 3D Printing Medical Devices
3D printing is being used for prosthetics, orthodontics, surgical preparation, and other applications. These devices may be subject to FDA regulation, Stark and AKS compliance, and FTC oversight.
Healthcare Compliance Issues for Medical Drones
Drone technology has many different medical applications including the delivery or medications and medical services. Developers and medical practices need to understand the healthcare compliance [...]
FDA Laws and Regulations About The Metaverse
Many metaverse augmented reality, virtual reality, artificial intelligence, and other med-tech applications will need to meet FDA medical device requirements.
Compliance Issues for Medical Fitness Centers, Gyms, and Wellness Centers – Part 1
As gyms and medical fitness centers expands the services and products they offer and depend more on physician referrals and doctor employment, compliance review becomes a must.
The Legal Dangers Physicians Face When Working with Third Parties
Physicians regularly work with businesses who want the doctors to use their products. To encourage physicians to choose their practice over competitor practices, vendors often offer incentives. [...]
Is my app an FDA-regulated medical device?
Is my app an FDA-regulated medical device? That depends, in part, on whether it makes medical claims and whether the app itself, in FDA's view, diagnoses and treats disease.
“The Doctor Weighs In” Features Interview on FDA Mobile Medical App Regulation
Blogger Patricia Salber, MD MBA featured Understanding whether a medical app needs FDA regulation can be tricky on The Doctor Weighs In. In this videotaped interview, held at the 2015 Stanford [...]
The Next Healthcare Revolution is Inside You: Wearable Health Tech Legal & Regulatory Issues Will Astound Us
If you want to know where the next healthcare revolution will come from, look inside. Physical medicine becomes virtual medicine, becomes mobile healthcare, becomes wearable health and then [...]
If your medical device requires FDA 510k clearance but you put it on the market without a 510k, what happens?
If your medical device requires FDA 510k clearance but you put it on the market without a 510k, what happens?Many clients have asked us: do we have a medical device? Do we need to submit a 510k? [...]
How are home health kits regulated under FDA and state law?
If you've designed a home health kit to test for, say, pregnancy or HIV, can you go ahead and market the product without FDA clearance or state law authorization? FDA regulates some health test [...]
Medical device advertising: free speech or conspiracy?
If you think medical device advertising is immune from criminal prosecution, look to the current charges against the CEO of Vascular Solutions.
Michael H Cohen Speaks on MHealth & Wearable Health Technology: Will FDA Legal Compliance Stymie or Promote Innovation
Healthcare & FDA lawyer Michael H Cohen speaks on MHealth & Wearable Health Technology: Will FDA Legal Compliance Stymie or Promote Innovation, at the Health Law Section of the Los Angeles County [...]
Daily Journal Publishes “FDA’s General Wellness Guidance is Welcome News”
The Daily Journal published FDA’s General Wellness Guidance is Welcome News by healthcare and FDA lawyer Michael H. Cohen. The article (Cohen.P.0129) goes through FDA's general wellness guidance [...]
Daily Journal publishes “Future of Medicine is Just a Tap Away” as lead front-page article
The Daily Journal, California's largest legal news provider, published Future of Medicine is Just a Tap Away, by healthcare & FDA attorney Michael H. Cohen.
Tweet Your Medical Device Ad But Watch the FDA Hammer
The FDA provides guidance for pharmaceutical and medical device manufacturers as to how to present risk and benefit information for their medical devices and products on social media.
FDA Mobile Medical App Guidance Reads FDA Medical Jurisdiction Expansively
The FDA's Mobile Medical App Guidance contains many nuanced definitions that determine whether your mobile app will likely be regulated by the FDA as a medical device.Recent clients have asked [...]
