FDA CDRH Learn

FDA's Center for Devices and Radiological Health has provided a set of resources including videos and presentations on how to navigate the many aspects of medical device product regulations. The modules are broken into these sections:

  • Registration and Listing
  • How to Study and Market Your Device
  • Postmarket Activities
  • Unique Device Identification (UDI) System
  • Specialty Technical Topics
  • Radiation-Emitting Products
  • In Vitro Diagnostics (IVD)
  • Industry Basics Workshop Series

There is lots of good information here and new information is added weekly. We'll continue to update StartupFDA with highlights and summaries.

FDA PreCert Program

The FDA recently announced their Digital Health Software Precertification (PreCert) Program, which is a piece of the Digital Health Innovation Action Plan. The goals of this program are to:

  • enable a modern and tailored approach that allows software iterations and changes to occur in a timely fashion;
  • ensure high quality medical product software throughout the life of the product by enabling companies to demonstrate their embedded culture of quality and organization excellence (CQOE); and
  • be a program that learns and adapts and can adjust key elements and measure based on the effectiveness of the program.

The first 9 participants in the program have already been announced by the FDA:

  • Apple, Cupertino, California
  • Fitbit, San Francisco, California
  • Johnson & Johnson, New Brunswick, New Jersey
  • Pear Therapeutics, Boston, Massachusetts
  • Phosphorus, New York, New York
  • Roche, Basel, Switzerland
  • Samsung, Seoul, South Korea
  • Tidepool, Palo Alto, California
  • Verily, Mountain View, California

Keep an eye on the pilot program webpage for updates and the details for the January 2018 workshop.

What regulation applies to your Mobile Health App?

Find out which federal laws you need to follow when developing your mobile health app. These 10 questions will help you understand which of the following laws apply:

Health Insurance Portability and Accountability Act (HIPAA)

The Office for Civil Rights (OCR) within the U.S. Department of Health & Human Services (HHS) enforces the HIPAA rules, which protect the privacy and security of certain health information and require certain entities to provide notifications of health information breaches.

Federal Food, Drug, and Cosmetic Act (FD&C Act)

The FDA enforces the FD&C Act, which regulates the safety and effectiveness of medical devices, including certain mobile medical apps. The FDA focuses its regulatory oversight on a small subset of health apps that pose a higher risk if they don’t work as intended. 

Federal Trade Commission Act (FTC Act)

The FTC enforces the FTC Act, which prohibits deceptive or unfair acts or practices in or affecting commerce, including those relating to privacy and data security, and those involving false or misleading claims about apps’ safety or performance.

FTC’s Health Breach Notification Rule

The FTC's Health Breach Notification Rule requires certain businesses to provide notifications following breaches of personal health record information. 

Biotech Companies in Y Combinator

Elizabeth Iorns is cofounder and CEO of Science Exchange. She’s also a Part-Time Partner at Y Combinator.

In this interview she answers some of the most common questions YC receives from founders in biotech, such as "Why should I apply to YC?" and "Where do you put the money to work during YC?"

What we kind of missing is the funding and the mentorship because it is a steep learning curve to navigate how you take a drug to market through all of the regulatory hurdles. If we can build a path that supports those people more effectively, that’s going to be, I think the killer sort of application. It’s going to be how do you get a lot more of these shots on goal and actually get a lot more people involved in the biotech innovation ecosystem developing companies and bringing drugs to market and not just staying in academia.
— Elizabeth Iorns