Field Reports
Design: A Look into the Future of Prosthetics
I had the pleasure of hearing industry pioneer Gerald Loeb, MD, speak last night about the future of prosthetics and robotics. He spoke at Stuart Karten Design in Marina del Rey, CA. Loeb, who is a professor of biomedical engineering at USC, is one of the original developers of the...
Mobile Phone Medical Device
In the upcoming February issue of MD&DI, we feature a fanciful medical device that takes the elements of a smart phone and pairs it with medical device applications. Turns out, our dream device is not so far from reality. According to the report, Professor Aydogan Ozcan of UCLA...
Clarity on Manufacturing Rules for Combination Products May Come Soon
FDA's Office of Combination Products is expected to publish two proposed rules by the end of the year, its director said at the Regulatory Affairs Professionals Society annual conference this week. Thinh Nguyen said the topics are good manufacturing practices for combination...
Proactivity Is Key When It Comes to COA Studies
More than 60% of PMA products have condition-of-approval (COA) studies, also called PMA orders, attached to their approval. That means PMA sponsors should not be thinking about whether they will have to perform COA studies, but about what those studies should look like. Otherwise,...
510(k) Process Could Come Under Fire
The Government Accountability Office is preparing a report on whether the 510(k) process is adequate enough to assess the safety and effectiveness of medical devices, and the buzz at the Regulatory Affairs Professionals Society annual conference this week is that it may have some...
CDRH Issues Flutter Device Guidance
CDRH has published a new guidance, "Clinical Study Designs for Catheter Ablation Devices for Treatment of Atrial Flutter." It addresses using a randomized clinical trial approach for clinical studies for catheter ablation devices that treat atrial flutter. The first devices of this...
Cardinal Cited Over Sharps Container QSRs
An FDA inspection of a Cardinal Health facility in Dublin, OH that distributes point-of-use sharps containers has determined that the facility does not have adequate management controls as part of an effective quality system. The inspection found that a number of a quality system...
Could Registry Help Thermal Ablation Trials?
FDA wants to know whether a registry could help standardize feasibility trials for local treatment of small breast cancers with different ablation devices and therapies, according to a Federal Register notice. FDA particularly wants to understand how such trials can be designed to...
Transfer from Design and Engineering to Manufacturing Is a Process
Design and engineering are hugely important functions -- but their labors won't bear much fruit if their work can't be translated into the manufacturing environment. Johnson...
Firms Must Show Evidence that Compliance Programs Work
It is not enough for medical device companies to have a compliance program relating to physician payments and perks. It is up to each company to demonstrate evidence that the program actually works, a consultant told those at the Medical Device Manufacturers Association meeting on...