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.
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.
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. [...]
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? [...]
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 [...]