The entrepreneur & the FDA

By Rock Health Intern Jess Hershfield

View the full presentation below, or read below for our recap.

Confused by how to approach the FDA? Don’t worry, you’re not alone. Rock Health brought in the experts last Thursday to help navigate our start-ups to successfully approaching the FDA. Who better to teach this workshop then former Special Assistant to the President for Health Care, Bob Kocher, and former Associate Chief Counsel at the FDA, Raju Goyal?

Bob first started out by explaining the purpose of the FDA and its organization. Bob understands that the FDA has been under scrutiny lately for slower and expensive processing time; however, he points out that many of these views may be due to poor press and stereotyping, not actual truth.

The FDA’s mission:

  1. The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
  2. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

In order to promote this mission, the FDA is broken into two major offices:
Office of the Commissioner (OC): responsible for effective implementation of the FDA’s mission.

  • Currently, Margaret Hamberg, MD, is the commissioner of Food & Drugs. She is the highest-ranking official at the FDA.
  • The OC also oversees 3 FDA-wide programs: The Ethics Program, The Good Clinical Practice Program & The Small Business Program

Office of Regulatory Affairs (ORA): lead office for all field activities of the FDA, with the mission of protecting consumers and enhancing public health by assuring compliance of the FDA regulated products.

  • In order to accomplish this mission, the ORA uses three primary types of specialists: Consumer Safety Officers who conduct ~20,000 inspections every year, scientists who analyze over 41,1000 product samples in ORA’s 13 laboratories annually and public affairs to explain FDA policies

The FDA is subsequently divided into six major centers: Food Safety and Applied Nutrition, Drug Evaluation and Research, Devices and Radiological Health, Biologics Evaluation and Research, Veterinary Medicine, and Tobacco Consumer Protection. Since the vast majority of the products our health tech start-ups will produce will fall under the devices and radiological health, we will focus on that major center for the rest of the discussion. However, if you are interested in learning more about the other centers, please visit the FDA’s website.

The Devices and Radiological Health Center:

Next, Bob explained the guiding principles the FDA uses for determining Mobile Health Policy:

  • Support innovation in both the public and private sector
  • Support delivery system reform, Affordable Care Act implementation, HITECH Act
  • Augment OpenGov and HHS Health Data Initiative
  • Drive down healthcare costs and improve quality of care
  • Improve the public health
  • Create jobs and GDP growth

Finally, Bob walked us through the scope of FDA regulation within the Mobile Health industry, and pointed out that the majority of products and services our start-ups are producing most likely will not be covered under FDA policy.

According to Bob, the only category the FDA has oversight in is “mobile medical devices,” which are subject to the 510K process. Mobile applications are not under FDA regulation, but may be required to register with the FDA. So, what qualifies as a Mobile App versus a device?

It is a medical device and regulated if:

  • It is used for diagnosis or treatment of a disease, for example an eye refractor.
  • It is an accessory to regulated medical device, for example a remote control to a pacemaker.
  • It transforms a mobile communication device into an already regulated medical device, for example an x-ray viewer.
  • To learn more about device classification click here.

Raju added to this, by explaining that the FDA does not classify the application as a medical device if the mobile app is, “solely used to log, record track evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness.” For example, a dietary tracking log would not be under FDA regulation. To see guidance documents, click here.

Bob finished the discussion, explaining his key takeaways for entrepreneurs looking to enter this space:

  • Most mobile health products are not going to be regulated.
  • If it is a mobile medical device, the 510K process is simpler, faster, and less expensive then the NDA process.
  • The 510K process will cost about $2000 during filing, more information on user registration here
  • Spend time on the FDA website reading guidance, communicate early, work with FDA experienced lawyers, and make sure your submission is complete.
  • An incomplete submission is the most common way companies face delays in processing.