Avoid common FDA mistakes marketing health products
Avoid these common FDA mistakes marketing health products: communicating with FDA without legal counsel, making disease claims, misunderstanding the rules.
OTC drug marketing legal checklist: 5 legal strategy steps
For an OTC drug marketing legal checklist, 5 legal strategy steps can propel you to market.
Is there a Moore’s law for law? Can healthcare and FDA laws regulate convergent, exponential technologies?
Is there a Moore's law for law? Can healthcare and FDA laws regulate convergent, exponential technologies?
Cosmetic or drug? Claims matter for body sculpting and slimming products
Cosmetic or drug? Claims matter for body sculpting and slimming products, and all health and wellness products.
FDA medical device guidance – substantial equivalence
According to FDA medical device guidance - substantial equivalence in the 510(k) premarket notification process can be clearly determined if you know the underlying legal rules. One of the [...]
Understanding FDA tobacco compliance – legal requirements, warnings, advertisements, and other regulatory restrictions
FDA's tobacco products deeming rule hits companies with many compliance obligations for both existing tobacco products and new products "deemed" to be subject to FDA jurisdiction. This is a [...]
FDA Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act: A brief overview
If you are a retailer, manufacturer, distributor, or importer of tobacco products, become familiar with the final rule by FDA Deeming Tobacco Products to be Subject to the Federal Food, Drug, and [...]
Digital health advances set healthcare law on edge
Digital health advances set healthcare law on edge because health tech develops exponentially while laws grow linearly.
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.
Dietary supplement legal review could save your company
If you want to sell healthcare products online, the legal hurdles can be steep.
“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 [...]
Dietary Supplements, Cosmetics, Medical Devices – Why Substantiating Claims Matters
Substantiating claims matters whenever you bring a dietary supplement, cosmetic (or skin care product), or medical device to market - why?
Digital health personalizes medicine, revolutionizes healthcare, and makes healthcare law anachronistic
By putting healthcare in the hands of patients, healthcare technology is not only revolutionizing the way we think about medicine, but also the way laws shape personal health.
4 Ways to Minimize the Risk of an FDA, FTC or Private Plaintiff, Healthcare Fraud Label When Marketing Healthcare Products
Whenever you market a healthcare product, beware of potential FDA and FTC enforcement as well as private plaintiffs who can sue for false advertising, unfair competition, deceptive and misleading [...]
FTC Slams Fat Burning, Calorie-Blocking and Body Slimming Marketing
Would you like to lose weight without diet or exercise, by a magical fat-burning, calorie-busting, body-slimming dietary supplement or cream? Here's how.......
Which disruptive healthcare innovations will push medical frontiers in the next 5 years?
Pundits prognosticate, but how do we measure a future for healthcare when every trend morphs asymptotically?
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 [...]
Dietary Supplements – Strategies to Reduce FDA Risk
Because marketing and distributing dietary supplements carries FDA risk, we offer sample strategies to reduce FDA risk when selling dietary supplements.
