Eisner Safety Consultants

Comment on Draft Guidance for Industry, 3rd Parties & FDA Staff: ISO 13485:2003 Voluntary Audit Rprt Submission Program http://ht.ly/1OeVB

Follow FDA CDRH (Device Info & CDRH Industry) on Twitter http://ht.ly/1Lc7D
Available Twitters as of May 14, 2010

FDADeviceInfo – Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics.
FDAcdrhIndustry – Helpful links, information, and news for industry related to medical device and radiation-emitting products.

FDA establishes a Home Use Devices Web PAge – Repository of Info on FDA perspective for Home Use Med Dvcs http://ow.ly/1El0q

FDA Workshop on Med Dvc Use in Home Environ: Implications of Med Dvc Technology Migrating Into Home Use, May 24, 2010 http://ow.ly/1EjTN

Draft FDA Guidance – Infusion Pumps – Total Product Life Cycle – Premarket Notification [510(k)] Submissions http://ow.ly/1EjNL