MAR 23, 2005

To quote Moby, "Why does my heart feel so bad?" Added an SOP and supporting FORM to document the decision of whether or not to file an FDA 510(k) submission to the Downloads page. 510(k) third-party review organizations generally require a "Justification for 510(k)" section in the 510(k) submission. This requirement is not documented in any 510(k) guidance document, nor in the Agency's 510(k) regulations (21CFR Sec 807 Subpart E). Follow the procedure, print out and annotate the FORM, include it in the 510(k) submission, file a copy of the completed FORM in your Design History File (DHF), and attach a copy of the FORM to the releasing ECO.

Added an SOP and supporting FORMs for the Control of Advertising, Labeling, and Promotional Materials to the Downloads page.

MAR 17, 2005

St. Patrick's Day. "So why the pretty pictures?" Let's face it, FDA regulatory affairs and quality assurance is, well, boring. While I may get excited about this stuff, for the rest of the world, it's a good cure for insomnia. You might as well have something nice to look at. Now go have a whiskey and a Guiness :)

NOV 14, 2004

Added various 510(k) summaries to download. End of the "mystery meat navigation." Added a jscript to fade in/out summary text about each icon in the navigation bar. The fade in/fade out is real cute, and everybody will be sick of it in about 2 minutes. Special thanks to the fine folks at GreyWyvern for the fade in/out script. The hardest part was getting two actions to occur OnMouseOver - the pop-up text, and the icon change in the navigation bar. Think I'll go have a whiskey and a Guiness :)

NOV 11, 2004

Armistice Day. Added Google Site search box to index page; other minor updates.

JUL 22, 2004

Hard to believe that it has been two months...
Updated the Downloads page to include the sample clinical study CRF and sample QSR procedure.

MAY 22, 2004

"Look, Ma! No tables!" Complete site re-design. No tables for gross page layout. No bit-fiddling of single-pixel transparent gif's. No frames. No blinding migranes. No Frustrated-Parrot-Syndrome, plucking out all my feathers. CSS, Javascript, and DHTML are the Gifts of the Gods. View the css, inspired by Blue Robot.
What doesn't work: Safety Engineering has a content placeholder. Most of the Downloads documents are not yet loaded.