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November 2012 FDA CDRH Improvements & Plan of Action for Premarket Review of Devices
Access Here
October 1, 2012 FDA Issues new guidance to industry. To access latest list Access Here
September 2012 GAO Mobile Information Security Report to Congressional Committees Citing Better Implementation of Controls for Mobile Devices Should Be Encouraged.
Millions of Americans currently
use mobile devices—e.g., cellphones, smartphones, and tablet computers—on a
daily basis to communicate, obtain Internet-based information, and share their
own information, photographs, and videos. Given the extent of consumer reliance
on mobile interactions, it is increasingly important that these devices be
secured from expanding threats to the confidentiality, integrity, and
availability of the information they maintain and share.
Accordingly, GAO was asked to determine (1) what common
security threats and vulnerabilities affect mobile devices, (2) what security
features and practices have been identified to mitigate the risks associated
with these vulnerabilities, and (3) the extent to which government and private
entities have been addressing the security vulnerabilities of mobile devices. Access Full Report Here
October 13, 2011 FTC imposed fines, product recall and refunds for consumers who purchased Reebok toning shoes - Apps advertising fitness products and exercise enhancing supplements are just as vulnerable. Makers of products whose claims alter a structure or function of the body need to have the research that backs up the claims, and product registration/clearance to market with the appropriate regulatory body to remain commercially viable. Read More
October 5, 2011 FTC proposing changes to strengthen oversight, compliance and protections of COPPA Rule around evolving technology development - Online services directed to children under 13 years of age, where collection of personal information occurs requires that business operators must obtain verifiable consent from parents before collecting, using or disclosing such information. FTC enforcement of COPPA Rule is applicable to mHealth, telehealth and medical application technologies. Read More
A sweeping overhaul plan developed by the Clinical Trials Action
Group, commissioned by the Australian government in 2009 to help retain and grow
the $1-billion Australian business.
The Clinical Trials Action Group commissioned by the Australian government releases a report recommending a standardized ethics approval process and
concurrent approvals for multi-site studies. In addition, the report
recommends a nationalized standard for trial governance approvals. Read Story Here
The first medical app ever in the Apple Inc. (NSDQ:AAPL) app store is now the first app to receive 510(k) clearance from the Food & Drug Administration to be used to review and make medical diagnoses of MRI, CT and PET scans. Mass Device
Healthcare providers and aeronautics industry association members this month urged the Federal Communications Commission to quickly approve their plan for setting aside bandwidth for mobile body area network technology (MBAN). Computerworld
Report Gives Good Marks to European Device Regulations. Article outlines key differences in medical device oversight between FDA and the European Union where in the US, approval and regulation of devices include issuing recalls and safety alerts all pass through the FDA, a Federal agency where in the EU, the approvals are handled by 74 for profit companies called Notified Bodies. The article states, in Europe there is no central database to find recall alerts, instead Filed Safety recall notices (the equivilant of a recall notice are posted on public websites) Member Countries are required to file major safety issues in reports known as National Competent Authority Reports which are submitted to the European Commission. http://www.dotmed.com/news/story/15254
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