New MDDS Final Rule Offers Class I Status For Off-The-Shelf Medical Devices

A new FDA final rule for Medical Device Data Systems (MDDS) went into effect this past month, with the intent of simplifying the regulations surrounding a significant portion of IT equipment and software used during the provision of health services. The key aspect of this new final rule is the reclassification of certain MDDS as […]

FDA: For Corrective Action Plans, Where are the Resources?

Imagine the stream of firms that venture in to their respective FDA District offices to give presentations on their Warning Letter response and to offer their assurance that they truly “get it”. You can be sure that theses firms had several “dress rehearsals” to hone their material before stepping into what they perceive to be […]

Increased FDA Scrutiny of Medical Devices Imported to the U.S.

MDCI, a full-service CRO, has recently run across a number of cases where companies who have been importing medical devices into the U.S. for years suddenly encounter issues at U.S. Customs. In some cases, companies are not even aware that their products are regulated as medical devices by the FDA. In others, shipments of medical […]

Some Pharma People Love Fighting Fires

I am convinced that there is an element in some pharmaceutical companies that enjoys the adrenaline rush of a crisis. These are the people who descend upon problems and save the day through sheer grit and determination. They work late to pull the proverbial baby out of the fire.  They are known as having a […]

FDA May Make Failed Medical Device Info Available to the Public?

Learning from the failures of others is one of the most basic building blocks of scientific discourse, and medical device companies may soon gain access to an important resource from the FDA that could offer substantial insight when it comes to device development. The Administration is considering making public files that describe failed medical devices […]

Business Process vs. Compliance Process: What’s the Difference?

Having recently flitted about on several of our finest air carriers across several continents, I have thought about how certain practices by the flight attendants are predictably consistent, and others vary. For example, we’re always told to turn off our electronic devices at the point when the airplane doors are closed. However, when it is time to […]

FDA Provides New Final Rule on Medical Device Apps

We have previously posted blog articles regarding software applications used as medical devices and how they are affected by FDA regulations, but a new ruling by the FDA has clarified some of the uncertainty surrounding this type of technology. The recently published final rule regarding Medical Device Data Systems (MDDS) addresses several areas of concern […]

3 Pharma Industry cGMP Compliance Trends

It must be that time again when conference planners rack their brains on how to bolster dwindling attendance, because several have contacted me through this blog to ask my opinion on major trends in the pharmaceutical industry. So with this edition I offer my opinion not only to those conference planners, but also to my […]

Ningbo Smart Warning Letter all about Data Integrity

The Warning Letter to Ningbo Smart Pharmaceutical Company (dated 3/3011) revealed that they had reported conformance to specifications on Certificates of Analysis when in fact—no testing was done. (Among other issues.) In understated language, the FDA informed Ningbo Smart, “It is essential that your firm only report results to customers when you have actually performed […]

FDA De Novo Process 101 For Medical Devices

One of the most frequent questions MDCI fields from new medical device companies relates to the FDA’s “De Novo” process. In fact, they get so many inquiries about the De Novo process that they put together this post that addresses the history and function of the process and offers some guidance regarding its viability as […]
« Older Entries
Newer Entries »