Posts tagged with
“FDA”

1 projects are tagged with “FDA”.

The FDA is eager to show improvement of a performance self-assessment which revealed “a steady decline” of its premarket medical device approval program between 2000 and 2010. In a recent report on policies and initiatives, the FDA device arm (CDRH) claims it approves medical devices much faster than five years ago. The Agency also outlines […]

StarFish Medical recently worked with Larry Spears, Former Deputy Director FDA/CDRH Office of Compliance and FDA Investigations, as part of our ongoing efforts to improve and train our quality practices. During our breaks, I spoke with Larry about life after the FDA, how firms can best prepare for regulatory submissions, and the new open nature of the […]

Recently the FDA posted two draft guidance documents that outline FDA current thinking about low-risk devices intended to promote general wellness and the risk classification approach to medical device accessories. I previously wrote about the general wellness draft guidance.  This blog analyses the FDA  medical device accessory draft guidance.  In both cases, less regulatory burden […]

On Friday, January 16, the FDA posted two draft guidance documents that outline their current thinking about low-risk devices intended for general wellness and medical device accessories. Less regulatory burden will make a huge impact on the ability of low risk devices inventors to bring product to market faster and cheaper. This blog analyses general […]