FDA reimagining oversight of digital health technology

 “Software Precertification (PreCert) Pilot Program.” – new pilot program

  • looking first at the software developer and/or digital health technology developer, rather than primarily at the product

Goals 

  • modern approach to software iterations and changes
  • high quality medical product software throughout the life of the product
  • adjust key elements and measure based on program effectiveness

LEARN


Image Credit: FDA

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s