Last December Apple met with the FDA to get some clarification about what types of health apps and devices would or would not fall under FDA rules and regulations. It’s an interesting question that a lot of device makers are going to have to consider as more and more health-oriented wearables come to market.
When it comes to medical devices the FDA has a slew of rules and regulations. There are all sorts of things that are required to go through rigid clinical tests and trials, reports have to be filed and the FDA has the power to regulate, accept or reject medicines and medical devices.
In an interesting article on the imedicalapps.com website they speculate that when meeting with the FDA Apple wanted to make sure that they knew where the lines were drawn so that they would be prepared later on when they launched their HealthKit initiative. Once they knew the rules about what did or didn’t fall under the FDA’s domain they could either make sure they never crossed that line or be very careful when stepping over it.
In the article by Satish Misra, MD and Iltifat Husain, MD they pointed out that during the keynote address at Apple’s developer event last month some of the statements made brought up some questions.
You have to give Apple credit for checking into the legalities of health-oriented products and services before they began stocking the shelves with devices. I wonder how many other companies out there with health-related wearables, apps or services have checked with the FDA to see if they might be crossing some lines they shouldn’t be.
You can read the full imedicalapps.com story here.