9 Companies: Could OPKO possibly be picked?
Aug 17, 2017 4:08:57 GMT
icemandios, thought013, and 1 more like this
Post by deborah on Aug 17, 2017 4:08:57 GMT
blogs.fda.gov/fdavoice/index.php/2017/07/fda-announces-new-steps-to-empower-consumers-and-advance-digital-healthcare/
Claros1 or 4Kscore?
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:
Provide access to measures for developing, testing and maintaining software products and demonstrating a culture of quality and organizational excellence measures by KPI;
Collect real-world post-market data and provide it to FDA;
Meet with FDA for real-time consultation;
Be available for site visits from FDA officials; and,
Provide information about the firm’s quality management system.
Claros1 or 4Kscore?
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:
Provide access to measures for developing, testing and maintaining software products and demonstrating a culture of quality and organizational excellence measures by KPI;
Collect real-world post-market data and provide it to FDA;
Meet with FDA for real-time consultation;
Be available for site visits from FDA officials; and,
Provide information about the firm’s quality management system.
