FDA

Posts tagged with “FDA”

Virginia Anastassova

FDA reports faster medical device approval

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 […]

Vesna Janic

Advice from a former Deputy Director FDA/CDRH Office of Compliance and FDA Investigations

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 […]

Vesna Janic

StarFish analysis: Medical device accessory draft guidance

Recently the FDA posted two draft guidance documents that outline FDA current thinking about low-risk devices intended to promote general wellness and the risk classification approach to medical device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 I previously wrote about the general wellness draft guidance.  This blog analyses the FDA  medical device accessory draft guidance.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

Vesna Janic

Great News for manufacturers of Medical Device Accessories and products intended for general wellness!

On Friday, January 16, the FDA posted two draft guidance documents that outline their current thinking about low-risk devices intended for general wellness and medical device accessories.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 […]

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