Perhaps I did not understand the proposed legislation. My interpretation is, regardless of FDA and NRTL assessments and certification, that the failure of a fully conforming device will make the vendor subject to all manner of litigation, and that there is no such thing as all due diligence.
Please comment if I am not correct. Brian > -----Original Message----- > From: Andy Clifford [mailto:[email protected]] > Sent: Tuesday, June 16, 2009 8:06 AM > To: 'Brian O'Connell'; [email protected] > Subject: RE: [PSES] U.S. Medical Device Safety Act > > 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 > > -----Original Message----- > 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]>
