What does Adulterated Mean?
A surprise visit from FDA and a non-compliant QMS will likely result in devices being identified as adulterated. Entering adulterated devices into commerce in the United States may result in a warning letter.
A surprise visit from FDA and a non-compliant QMS will likely result in devices being identified as adulterated. Entering adulterated devices into commerce in the United States may result in a warning letter.
When developing highly complex medical devices, the mountain of “interesting” ideas that result from traditional brainstorming all too often buckles under technical scrutiny. A more efficient and effective way to generate and refine ideas that are technically viable is needed.
In the United States, to manufacture and/or enter devices into commerce, device establishments are expected to have written procedures that are fully implemented and in compliance with the QSR and subsidiary regulations. Do not be that organization that receives 13 Form 483 observations because procedures have not been established.
Ever since the advent of laparoscopic surgery some 25 years ago, payers have become wary of minimally invasive surgery. What should device manufacturers do?
Ever since the advent of laparoscopic surgery some 25 years ago, payers have become wary of minimally invasive surgery. What should device manufacturers do?
Script written procedures and actually use the procedures to run your organizations. Without written procedures, there is nothing but chaos.
Production and process control is not a difficult section of the QSR to comply with. However, it does take some work scripting procedures that delineate the production process.
Management responsibility is one of the most important requirements delineated in the QSR. If management has no clue as to what is going on in their facility or fails to take appropriate action when serious issues transpire, then just maybe a warning letter isn’t appropriate.
No matter how tortuous the path to durable coverage and adequate payment for a new technology, the bedrock of the entire reimbursement process relies on the clinical evidence of safety and effectiveness. This inaugural blog post is the first in a series focused on the key reimbursement issues in this fluid health care environment.
No matter how tortuous the path to durable coverage and adequate payment for a new technology, the bedrock of the entire reimbursement process relies on the clinical evidence of safety and effectiveness. This inaugural blog post is the first in a series focused on the key reimbursement issues in this fluid health care environment.
Whenever phrases such as “data falsification” are referenced by FDA in a warning, the offending organization will probably become familiar with the acronym DOJ, as in investigation. Falsifying data that may have resulted in the overall compromising of product safety and efficacy is a serious accusation.
In the face of new potentials and new demands in the health care space, as well as the digitization of daily life, the health care industry is feeling significant pressure to reinvent itself and keep up. The digital transformation of health care is imminent.