FDA: Medtech recalls up 97% since 2003, but that's a good thing
March 21, 2014 by Arezu Sarvestani
The annual number of medtech recalls nearly doubled from 2003 to 2012, but FDA regulators are calling the skyrocketing figures a win.
There were 604 total recalls in 2003, compared with 1,190 in 2012. The number of Class I recalls, tied to product defects that the FDA says pose a risk of "serious adverse health consequences or death," increased more than 8-fold, from 7 in 2003 to 57 in 2012. Read more
Avedro application needs more work, FDA says
March 18, 2014 by Arezu Sarvestani
Massachusetts ophthalmic devices maker Avedro has some issues to address before the company can move forward with an FDA New Drug Application for its light-based cross-linking product for treatment.
The company announced today that the FDA send back new inquiries for the NDA, citing “a number of areas of the application which require additional information.” Avedro said that it plans to work closely with FDA officials to address any short-comings in the application. Read more
FDA no longer notarizing CDRH export certificates
March 19, 2014 by MassDevice
By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration has stopped notarizing Center for Devices and Radiological Health export certificates including Certificates to Foreign Government (CFG), Certificates of Exportability and Non Clinical Research Use Only Certificates.
US-based Medical device manufacturers planning on exporting their products to countries requiring CFGs should be aware of this administrative change. According to the FDA, the agency is under no obligation to notarize export certificates; beginning March 1, 2014, the regulator has provided only signatures of officials and embossed federal seals on export certificates that “are considered official and authentic documents that do not require further verification or authentication.” Read more
Korean regulators waive registration requirements for some mobile medical devices
March 21, 2014 by MassDevice
By Stewart Eisenhart, Emergo Group
The South Korean Ministry of Food and Drug Safety (MFDS) has announced steps to loosen medical device registration requirements (link in Korean) for some fitness-related mobile medical products — including Samsung’s line of Galaxy mobile and wearable products for leisure and fitness use.
According to current Korean medical device regulations, no distinctions are made between devices such as heart rate monitors used in medical or sports and leisure settings. Previously, industry participants had voiced concerns that the MFDS would apply South Korean medical device registration requirements broadly to smart phones and mobile applications that do not fall neatly into regulated medical device categories; now it appears as though the MFDA plans to address mobile medical app regulation in a way similar to that in the US. Read more
Sentinel: Harnessing the power of databases to evaluate medical products
March 20, 2014 by MassDevice staff
Clinical trials are designed to evaluate the safety and effectiveness of medications. But the number of participants in clinical trials represents only a fraction of the number of people who will ultimately use the product after FDA approves it. Occasionally, rare and unexpected health problems (which we call “adverse events”) become apparent only after a medical product is on the market and many more people use it. That’s why it’s so important for FDA to continue to monitor the safety of medical products, a practice called surveillance.
Most safety surveillance systems are passive: They rely on health care professionals and consumers to notice and report adverse events. Although these passive systems remain essential, they have certain limitations. For example, health care professionals and consumers might not recognize that the product is the cause of an adverse effect and not report it to FDA. Or, they might report a suspected adverse event that’s not truly the cause of a problem the consumer experiences Read more
