The second phase of UDI compliance for Class II I/LS/LS medical devices has now been implemented, leaving Class II device manufacturers wondering how to best prepare for the device data submission deadline on September 24, 2016.
The FDA’s UDI mandate requires unique device identifiers (UDI) be included with labeling and packaging on all Class II medical devices and entered into the FDA’s Global Unique Device Identification Database (GUDID).Continue Reading
Preparing a central office or “war room” prior to an FDA inspection is key to making the process run as smoothly as possible.
This meeting point should serve as the “front room” to the area you’ve designated for the inspector to work. It should have everything you expect an inspector would want to see, organized for fast access during the meeting.
Being prepared for your inspector not only makes for a smoother inspection but also impresses a sense of readiness and cooperation, which can play to your favor when all is said and done.Continue Reading
How much does a warning letter actually cost?
It’s an important question, but an almost impossible one to answer confidently. Along with the direct costs of remediation, there are a variety of intangible expenses that simply can’t be quantified in full.
Add to this the fact that companies incur different expenses depending on the particular problems they’re facing and the issue of measuring the full impact of a warning letter only becomes more abstract.
While there is no hard-and-fast guide to measuring the costs of a warning letter, it is possible to shed some light on the hidden costs that typically follow one. To help you prepare financially as best you can and underscore the importance of maintaining quality standards, we’ve laid out five of the most expensive indirect costs of a warning letter.Continue Reading
In 2015, the FDA released their Request for Quality Metrics draft guidance, describing the measurements they’ll use to evaluate the quality of drug and biologic manufacturing.
But despite the many resources FDA has made available to help educate manufacturers on the use of collected data, companies are still struggling to understand what exactly the Agency wants to see in the data.
Many companies have trained themselves to focus on best practices determined by industry groups, but at the end of the day, it’s the FDA’s quality metrics criteria that matter most.
With that in mind, here are four things the FDA recommends for companies preparing their products for metrics reporting requirements:Continue Reading
To most hospitals and physicians, the Centers for Medicare and Medicaid Services’ (CMS) Meaningful Use program has been a disaster.
In the push to improve patient care, Meaningful Use incentivized the use of electronic health records (EHRs) in coordination with MACRA. In 2015, controversy turned to frustration as the program began issuing penalties to those who weren’t keeping up with the program’s stage-based implementation.
This January, facing mounting criticism, CMS’s Acting Administrator Andy Slavitt announced the program would be ending early in the middle of its second stage, adding that a replacement program would take its place.
While the specifics of the new program are still unknown, Slavitt acknowledged the medical community’s frustrations, admitting that the current criteria were divorced from how physicians practice and deliver quality care to their patients.Continue Reading