Category Archives: Presentations

Run the FDA RTA & e-COPY 510(k) Gauntlet

Filing a 510(k) according to the current FDA “refuse to accept” policy can be challenging.  The former checklist of a few pages is now more than 26 pages for a traditional 510(k).  The new policy is supposed to help FDA focus its resources on those submissions which are complete.  Unfortunately some of the quirks of the checklist and the UBER-interpretations of guidance documents and regulations have caught some folks with one or more recycles of their 510(k) submission.  At Paladin Medical, Inc. we have the experience to help you avoid the recycling syndrome by working with you early to plan the content of your 510(k).   Working efficiently and effectively with FDA is much more than checking boxes.  But in like token, we understand that the initial Refuse To Accept review is critical to speedy processing.  For example, we use the checklist to annotate and direct the initial reviewers attention to the location in the document that the required elements can be found.  We know where the trip wires are in the checklist that can stall an otherwise complete submission.   We’d like to share these tips and tricks of the trade with you and discuss your next submission project.  Maybe we can help, or maybe just a look at our presentation given to the LifeScience Alley “Smoldering Submission Issues” can give you the help you need.  Please go to the CONTACT PALADIN MEDICAL tab and sign in for the information request.  We can send a copy of the presentation to your email address.

QUALITY 101 a Hit

Elaine Duncan’s presentation to the LifeScience Alley REGULATORY 101 course was a hit with the attendees.  It didn’t hurt that each attendee received a free mini-regulatory booklet which contains the regulations for PART 11, GLP regulations, IDE regulations and QSRs all in one collection.  The talk demonstrated how the Quality System Regulations are a SYSTEM, interlocking the parts to provide a network of documentation of the quality efforts.  Comparisons between ISO 13485:2003 and Part 820 were intended to help the audience understand where key differences could lead to difficulties with FDA inspection if they are not addressed.  The presentation is available for download in this attachment.  If you would like a free regulatory booklet, please go to the Contact Us page and request the booklet.  LifeScience Alley Reg 101 Quality Systems


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