The new regulation has a word count nearly four times higher than its predecessor, the Medical Devices Directive (MDD), contains five more annexes, and uses the word “safety” 290 times, rather than just 40 times.   Continue Reading..

The definition of a medical device in the Federal Food, Drug and Cosmetic Act (FDCA) is purposefully broad — some say too broad. It allows the FDA to reserve potential oversight of many healthcare products, including software, and some software development companies have bristled at the FDA’s potential to regulate their products.  Continue Reading..

Whether you are developing a quality system for the first time or addressing an existing quality system’s shortcomings, utilization of process maps and other visual tools — combined with the four phases of continuous improvement — can be the difference between a business that thrives and a business that simply survives.  Continue Reading..

Current FDA and U.S. Department of Justice compliance trends reinforce that a company’s ability to accurately and quickly gather, analyze, and manipulate data is the key to avoiding enforcement actions. Here, we will highlight three particular areas of risk and discuss the merits of validated compliance-related data in appropriately designed and controlled systems  Continue Reading..

This retrospective looks at common errors we've encountered in presubmission documents we've reviewed in the course of consulting engagements, and provides tips for avoiding those errors.   Continue Reading..

In part one of this series, we discussed the differences between quality management systems (QSR) constructed based on the medical device industry’s quality system regulation (QSR) and those built based on the Clinical Laboratory Improvement Amendments (CLIA). In this second exploration of quality systems for CLIA laboratories, we’ll discuss how to make the most of your interactions with the FDA and third-party organizations.   Continue Reading..

The federal Clinical Laboratory Improvement Amendments (CLIA) are intended to ensure quality laboratory testing. Until recently, CLIA-certified labs and the tests that they develop/offer remained largely untouched, though not unnoticed, by the FDA. But draft guidance issued by FDA last October reaffirms the agency’s interest in these tests and its awareness of this segment of the industry. Here, we examine the ramifications of that...  Continue Reading..

Medical device industry headlines have been dominated in recent months by the significant regulatory oversight applied to promotional claims made for medical products, as well as the penalties imposed when manufacturers run afoul of those regulations. In this article, we outline best practices for companies wishing to proactively install safeguards between scientific and promotional exchanges with physicians and other HCPs.  Continue Reading..