The FDA has released its annual Medical Device Quality System Data report concerning Form 483 and Warning Letter Citations, and there's some good news to be found in the official report. Specifically, for the first time in four years the agency has reported a decline in the overall number of warning letters issued to medical device companies. Only 144 warning letters were issued for the 2013 calendar year, which represents a drop of 20 letters compared to the year before.
144 warning letters translates into 16 percent of all foreign firms being inspected having some type of quality system violation, with [...]
A new guidance document intended to assist small medical device manufacturers is now available from the FDA. 'Unique Device Identification System: Small Entity Compliance Guide" consists of a series of recommendations designed to help companies handle the requirements associated with the UDI system and Global Unique Device Identification Database (GUDID). The document is intended as a complement to the UDI system final rule that was established almost exactly one year ago in September of 2013.
The Universal Device Identification System was implemented as a way to ensure that all medical device labeling [...]
The FDA is moving forward with a series of upgrades to its IT infrastructure that will have a direct impact on how medical device companies submit and interact with 510(k) submissions as well as participate in the de novo process. The changes are intended to make communication between the FDA and manufacturers more efficient, as well as improve the speed of the review process and reduce its complexity.
One of the first steps taken has been to split 510(k) and de novo logging into two distinct submission types, which means that all de novo submissions moving forward will be given their own number unique [...]
Data security is a common rallying point for medical device manufacturers, especially those brave enough to enter the churning medical device app space. The ability of major corporations to protect the data of their users was highlighted by a spate of well-publicized hacks, including illegal access to information held by Apple's iCloud online storage system - an intrusion that has led the IT giant to make a dramatic change in its policy towards health care apps.
Apple is no longer willing to approve any medical device app that links to iCloud - even if that particular application works under the Apple [...]
Statistics show that women are more likely than men to use medical devices throughout their lives, the FDA reported. Manufacturers should consider women’s needs when designing medical devices and similar technologies, as women differ greatly from men in anatomy, physiology, illness symptoms, and disease risk.
The FDA Voice publication reports that the federal agency is working toward creating medical devices that better serve women by determining how medical technology particularly affects this gender. For instance, in August 2013, the Food and Drug Administration (FDA) released a [...]
The De Novo process was further simplified this past August with the release of a new draft guidance by the FDA. "De Novo Classification Process (Evaluation of Automatic Class III Designation)" describes the streamlined de novo classification process that has been in effect since the 2012 passage of the FDA Safety and Innovation Act (FDASIA).
Prior to the existence of the FDASIA, medical device manufacturers wishing to take advantage of the de novo classification process (which exists to help bring low-risk devices to market which cannot be linked to a predicate device as per the pre-market approval [...]
A recent post from the FDA's official blog - the FDA Voice - highlighted the gap between the patient populations used to gather trial data and the realities of the clinical landscape.
Specifically, according to the FDA's David Strauss, M.D., Ph.D., women are underrepresented in medical device trials to the point where the physiological differences between men and women could be having a negative effect on the validity of the data harvested from a given investigation. He mentions a CDRH data analysis of recent pacemaker therapy trials that found less than a quarter of participants were women, despite the [...]
The FDA has issued a new guidance document intended to clarify how medical device manufacturers should approach certain design decisions for products targeted for home use. 'Design Considerations For Devices Intended for Home Use' is the final version of the draft guidance initially published in early 2013, and while it does not add any new requirements for medical device companies marketing these types of products, it does unify existing standards..
The guidance document is comprehensive in its approach to how many different angles home use medical device design should be examined from. For example, the [...]
Welcome to the Aptiv Solutions medical device news roundup for August 2014! We will outline ten news articles filled with material that could push your company forward!
Coming up in this roundup: the U.S. Food and Drug Administration continues to develop new guidances for the medical device sector while the industry undergoes transformations internationally.
10) New facility to make Ottawa a centre for medical device commercialization
We’re starting off this month’s roundup with an article from the Ottawa Business Journal. This story revolves around the development of the Medical Devices [...]
The FDA has released a final guidance document on August 6, 2014 on In Vitro Companion Diagnostic Devices. The guidance defines IVD companion diagnostic device as an “in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product”.
FDA advises that in “most circumstances, an IVD companion diagnostic device and its corresponding therapeutic product should be approved or cleared contemporaneously by FDA or the use indicated in the therapeutic product labeling.” Furthermore, FDA encourages sponsors considering such development of [...]