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submissions, PMA, 510(k), advamed

Master 510(k), IDE, and PMA Submissions at AdvaMed's Workshops

Within driving distance to D.C.? There's still time to enjoy a few days..

usability, FDA, human factors, pma supplement, PMA, Case Studies, IEC 62366

FDA Approved: A Human Factors and Usability Case ...

About R&Q's Case Studies: We hope you enjoy our latest case study. View all of..

Q-Sub, FDA, Guidance Document, Pre-Sub, PMA, 510(k), Pre-Submission

Pre-Submission Program – Final Guidance

On February 18, the FDA issued the final guidance document for the..

FDA, medical device, PMA

Pediatric Subpopulations – Final Rule

On Friday, January 10, 2014 the FDA issued a final rule, which amends the..

Diabetes, Artificial Pancreas, FDA, Artificial Organ, PMA

First Artificial Pancreas receives FDA Approval

Upon my nightly adventures of surfing the World Wide Web I came across this..

medical device review, FDA, Guidance Document, PMA

Acceptance and Filing Reviews for Premarket ...

In addition to the Refuse to Accept Policy for 510(k)s Guidance document I..

MDUFMA, Small Business, User Fee, Pediatric, PMA, 510(k), Discount

Deals and Steals

Thanksgiving night I was standing outside in the cold in a line that wrapped..

Medical Devices, Stents, Innovation, PMA, de novo, Disruptive Technology

Blockbuster is no more - A discussion on ...

Every time I go home to visit my parents, one thing that comes up more often..