FDA, Industry Make Strides on Case for Quality Guidance

FDA anticipates releasing its draft guidance on quality metrics for medical device firms in the next few months, the agency said.

The quality metrics initiative will allow firms to determine how products are performing in real-world scenarios during all three lifecycle stages: premarket, production and post-production. By developing metrics across the total product lifecycle, companies will be able to better assess their critical quality practices.

In 2014, the Medical Device Innovation Consortium created a quality forum in collaboration with the FDA and Xavier Health to develop key quality metrics.