Due to the new Medical Device Safety Act 2009, I might expect the risk assessment requirements of the 3rd edition to become more important, since the FDA, who may now share in a manufacturer's liability by approving test reports, will need more effort from manufacturers in order to demonstrate safety of their devices?
Andy From: Brian O'Connell [mailto:[email protected]] Sent: 11 June 2009 21:56 To: [email protected] Subject: [PSES] U.S. Medical Device Safety Act Medical Device Safety Act of 2009 (HR 1346) <http://thomas.loc.gov/cgi-bin/query/z?c111:H.R.1346:> comments by medical community <http://content.nejm.org/cgi/content/full/360/15/1550> The proposed bill would nullify the 2008 decision Reigel v. Medtronic, where the U.S. supreme court ruled that if your box is certified/tested to required normative standards and legislation, the mfr is generally immune >from civil litigation when the device fails through no fault of the mfr. (Yes I know that the case had to do with published product data and labels) The new stuff required by IEC60601-1 3d ed does not matter... Brian - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]> All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. Website: http://www.ieee-pses.org/ Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]> - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]> All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. Website: http://www.ieee-pses.org/ Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
