Digital Disruption in Pharma
101.7K views | +10 today
Follow
 
Rescooped by Pharma Guy from Pharma Industry Regulation
onto Digital Disruption in Pharma
Scoop.it!

FDA Looking for a Few Good Digital Health Product Developers for Its #FDAPrecert Program

FDA Looking for a Few Good Digital Health Product Developers for Its #FDAPrecert Program | Digital Disruption in Pharma | Scoop.it

Today, I’m excited to announce, as part of our broader Medical Innovation Access Plan, a new component focused on digital health innovation—the formal launch of our Pre-Cert for Software Pilot Program. This new program embraces the principle that digital health technologies can have significant benefits to patients’ lives and to our healthcare system by facilitating prevention, treatment, and diagnosis; and by helping consumers manage chronic conditions outside of traditional healthcare settings.

 

At the same time we are announcing this pilot, FDA’s Center for Devices and Radiological Health (CDRH) is publishing its Digital Health Innovation Action Plan to provide details and timelines for our integrated approach to digital health technology and the implementation of the 21st Century Cures Act. We’re telling consumers and the digital health industry how we will establish clear and consistent expectations for the products FDA regulates.

 

FDA designed the new digital health pilot program to include up to nine software firms of various sizes. Initial participants in this new pilot will range from small startups to large companies that develop both high- and low-risk software products that are devices. We want to include medical product manufacturers as well as non-traditional software developers. Given the amount of attention we’re getting, and the ongoing innovation in this space, I’m confident we’ll have strong participation in the new pilot.

 

Digital health product developers will be selected for the program based on the following:

 

The company must be in the process of developing or planning to develop a software product that meets the definition of a medical device;

  • The company must have an existing track record in developing, testing, and maintaining software products and demonstrating a culture of quality and organizational excellence measures that are tracked by Key Performance Indicators (KPI) or other similar measures;
  • And during participation of the pilot, companies must agree to:

 

  1. Provide access to measures for developing, testing and maintaining software products and demonstrating a culture of quality and organizational excellence measures by KPI;
  2. Collect real-world post-market data and provide it to FDA;
  3. Meet with FDA for real-time consultation;
  4. Be available for site visits from FDA officials; and,
  5. Provide information about the firm’s quality management system.
more...
No comment yet.
Digital Disruption in Pharma
What's going on in the world of social media, mobile apps, mHealth, wearable & other digital technologies impacting the health industry
Curated by Pharma Guy