Can the U.S. Maintain its Leadership Position in Medical Devices?
According to a recent PwC study, the U.S. medical device industry is facing stiffer competition by rival… [more]
Everyone Agrees the FDA 510(k) Process Needs to be Fixed
Both sides played it pretty nice at yesterday’s press conference unveiling a new study analyzing the… [more]
Taking a Utility From a Culture of Complacency to a Culture of Compliance
As the Electric Reliability Organization (ERO) continues to mature and provide leadership for electric… [more]
Handling a Warning Letter: If At First You Don’t Succeed…
Last year, we blogged about the most common drug and device GMP 483 items and how to respond to them… [more]
Chicken Little Was Right: FDA Will Enforce Part 11 "Soon"
I’ve got to admit, despite months (or years?) of hearing from those inside and close to the FDA that… [more]
Big NERC CIP Changes Looming
In less than a year the sweeping changes to the NERC CIP requirements will become effective. The changes… [more]
Is the FDA getting ready to crack down on medical device clinical trials?
Well, we told you 2010 was going to be a big year for the FDA. While most of us were enjoying holiday… [more]
Featured Posts
Can the U.S. Maintain its Leadership Position in Medical Devices?
According to a recent PwC study, the U.S. medical device industry is facing stiffer competition by rival countries – mainly Brazil, China and India. However, the U.S. innovation edge may face more threats from an inefficient American regulatory system, according to AdvaMed. Unveiling its "Competitiveness Agenda" at device maker Stryker in … [Read More...]
Everyone Agrees the FDA 510(k) Process Needs to be Fixed
Both sides played it pretty nice at yesterday’s press conference unveiling a new study analyzing the FDA’s 510(k) review process, but there’s a tension underneath it all: Industry generally thinks the FDA is way too slow and inconsistent in its 510(k) review process and threatens medical device innovation in the US, and FDA seems to agree … [Read More...]
Taking a Utility From a Culture of Complacency to a Culture of Compliance
As the Electric Reliability Organization (ERO) continues to mature and provide leadership for electric reliability, there have been many changes over the last four years. One of the most recent NERC initiatives is working with the industry on reliability excellence with a risk-based approach. Gerry Cauley, President and CEO of NERC, has … [Read More...]
Handling a Warning Letter: If At First You Don’t Succeed…
Last year, we blogged about the most common drug and device GMP 483 items and how to respond to them in writing. But what if your response is judged inadequate or the FDA otherwise issues a Warning Letter? First off, understand that the agency even at this point is strongly hoping you will voluntarily take the corrective action required so they … [Read More...]
Chicken Little Was Right: FDA Will Enforce Part 11 "Soon"
I’ve got to admit, despite months (or years?) of hearing from those inside and close to the FDA that the agency intended someday to begin actual enforcement of 21 CFR Part 11, I was beginning to have my doubts. No one likes to be told he’s crying wolf or acting like Chicken Little squawking about the sky falling. Finally, however, the … [Read More...]
Big NERC CIP Changes Looming
In less than a year the sweeping changes to the NERC CIP requirements will become effective. The changes will require that all registered facilities be considered, to some degree, a critical asset. There are going to be three levels of criticality when it comes to CIP – High, Medium & Low. According to NERC, the process and criteria currently … [Read More...]
Is the FDA getting ready to crack down on medical device clinical trials?
Well, we told you 2010 was going to be a big year for the FDA. While most of us were enjoying holiday treats or making new year’s resolutions, a leading FDA official said the agency was developing new guidelines designed to establish stricter standards for the data received from tests with human subjects used by medical device makers when they … [Read More...]