Medical device recalls for April 2014
May 2, 2014 by Arezu Sarvestani
April Summary
Class I recalls: 7
Class II recalls: 203
Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Draeger Medical Systems; Inc. Apr-10-2014 Draeger Oxylog 3000 plus ventilators – Draeger Oxylog 3000 plus ventilators; emergency and transport ventilator. Part number: 5704833 The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation; gives an audible alarm and displays the error message Poti unplugged. Read more
FDA seeks electronic medtech guinea pigs
April 30, 2014 by Arezu Sarvestani
U.S. medical device regulators are looking for volunteers to test out a software-based version of its 510(k) submission program, an alternative to submissions that traditionally require paper copies or compact discs.
The new "CDRH 510(k) eSubmissions Pilot Program" will guide users through creating and submitting a 510(k) medical device review application electronically. The FDA is hoping a few guinea pigs will volunteer to run the course and provide feedback. Read more
Amid public uproar, FDA mulls risk upgrade for controversial pelvic mesh
April 29, 2014 by Arezu Sarvestani
The FDA today issued a pair of proposed orders that would increase regulatory oversight of controversial pelvic mesh products, responding to a long-running public uproar about the implants’ potential for harm to women.
If finalized, the orders would bump the surgical mesh, used for transvaginal repair of pelvic organ prolapse, from the lower-risk class II up to class III devices, requiring that manufacturers submit premarket approval applications for evaluation by the FDA. The agency today opened up a 90-day comment period on the proposal. Read more
South African regulators publish draft medical device and IVD regulation
April 30, 2014 by MassDevice
By Stewart Eisenhart, Emergo Group
The South African Department of Health has published draft regulations for the country’s medical and in vitro diagnostic (IVD) device market for a three-month public comment period.
The proposed regulations would fall under South Africa’s Medicines and Related Substances Act of 1965, which would grant the health ministry’s Medicines Control Council the authority to oversee medical device and IVD registrations. Read more
Medical device regulatory changes in China: Emergo group analysis
May 1, 2014 by MassDevice
By Stewart Eisenhart, Emergo Group
The China Food and Drug Administration (CFDA) recently announced significant changes to its regulatory system for medical devices. Revised regulations will go into effect on June 1, 2014, affecting areas including new clinical trial requirements, Class I device reviews and registration validity timeframes.
Based on a careful Emergo Group analysis of the CFDA’s revisions, we’ve identified several key areas that will impact medical device registrations in China. Read more