Devine Guidance

Sixteen Form 483 Observations. Ouch!

By Christopher Devine, Ph.D.,
Devine Guidance International

There really is not much rocket science involved when attempting to determine the odds of a device establishment being awarded a prized agency warning letter when the establishment is on the receiving end of sixteen Form 483 observations during an inspection.

Patent Litigation:
Avoiding A Nightmare

By William H. Honaker, Dickinson Wright

There are usually only losers in patent litigation, so the best strategy is avoidance.

Featured Quote

It is critical that FDA be forward-leaning in making sure that we have implemented the right policies and regulatory tools, and communicated them clearly, to encourage safe and effective innovation. In this rapidly changing environment, ambiguity regarding how FDA will approach a new technology can lead innovators to invest their time and resources in other ventures.

— Scott Gottlieb, M.D., FDA

Ameing for Asia

Medical Software Regulations in Asia 2017

By Ames Gross, Pacific Bridge Medical

As standalone software becomes increasingly sophisticated, a number of regulatory bodies have begun to draft separate guidelines to ensure quality control, expedite product approval, and improve patient access to new technologies.

Cardboard Incubator Gives Preemies Better Chance of Survival

By Maria Fontanazza,
Editor-in-Chief

A low-cost infant incubator is designed to combat two of the three leading causes of infant death.