By Stewart Eisenhart, Emergo Group
Center for Devices and Radiological Health (CDRH) director Jeffery Shuren has advocated rejection of 510(k) clearances in instances where applicants’ predicate devices have undergone safety recalls.
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
By Stewart Eisenhart, Emergo Group
Center for Devices and Radiological Health (CDRH) director Jeffery Shuren has advocated rejection of 510(k) clearances in instances where applicants’ predicate devices have undergone safety recalls.
By Stewart Eisenhart, Emergo Group
New guidance from the US Food and Drug Administration spells out how medical device manufacturers and study sponsors should format standardized study data for electronic submission.
By Stewart Eisenhart, Emergo Group
European Union member states should take immediate steps to tighten regulatory controls over medical devices and technologies in the wake of revelations that French breast implant manufacturer Poly Implant Prothèse Company (PIP) used non-medical-grade silicone in its products.
By Stewart Eisenhart, Emergo Group
New informed consent requirements for some medical device clinical trials in the US will go into effect March 7, 2012.
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By Stewart Eisenhart, Emergo Group
Guidance published by the FDA in late 2011 intends to update regulatory requirements for medical device manufacturers responding to public and non-public requests for off-label information about their products.
By Stewart Eisenhart, Emergo Group
Mexican medical device regulator COFEPRIS has extended its Equivalency Agreement granting expedited reviews for some medical devices registered in the US or Canada to some devices approved or certified for sale in Japan.
By Stewart Eisenhart, Emergo Group
Russian authorities are expected to implement new medical device regulations concerning authorized representation, vigilance, country-of-origin approval and other issues within the next several weeks.
According to Emergo Group’s Moscow office, Roszdravnadzor and the Russian Ministry of Public Health are still negotiating aspects of the new regulations pertaining to clinical studies. But the new rules are anticipated to include the following components:
By Stewart Eisenhart, Emergo Group
China’s State Food and Drug Administration (SFDA) has waived local clinical trial requirements for 21 types of Class II medical devices equivalent to products currently on the Chinese market.
By Stewart Eisenhart, Emergo Group
The U.K. Department of Health has undertaken a campaign to expand the use of mobile medical devices and services to cover three million patients over the next five years.
By Stewart Eisenhart, Emergo Group
U.S. medical device manufacturers dealing with lower market demand and rising pricing pressure will rely more on acquisitions and stock maneuverings to offset challenging growth prospects.