Stay Up-To-Date With Industry Happenings

Our Client Alerts are our way of sharing current regulatory news and insights with our clients and friends of the firm. Our mailing list is huge and many of our Client Alerts are turned into trade press articles upon a media request to do so.

We pride ourselves in not publishing the pablum that everyone else says about a new law, regulation, guidance or regulatory initiative.

We bring to bear our experience, FDA relationships, our constant interface with FDA in meetings, phone calls and email communications to give you "inside baseball" insights into what it all means.

  • Open Letter To Office Of Device Evaluation Director Christy Foreman

    • Authored by: Mark DuVal
    • Published on: July 22, 2014

    Dear Ms. Foreman,

    Executive summary

    I wanted to follow-up on our telephone last meeting of June 16, 2014, with one of my clients who will remain unnamed in this public document. Let me first thank you for granting us that meeting which we took as a conference call not a face-to-face meeting. As you recall, we tried to explain our position on FDA's review of their 510(k) submission for which an NSE was issued on the grounds it allegedly raised different questions of safety and effectiveness.

  • 510(k)s/IDEs: The New Normal?

    • Authored by: Mark DuVal
    • Published on: January 1, 2012

    As many of you have encountered by now, FDA is not exactly shy when it comes to requesting clinical data for 510(k)s. Requests for clinical data are becoming the norm, rather than the exception. Today CDRH has a stag e-gating approach to the review of 510(k)s. They first review the file to determine if it meets the criteria for a 510(k), i.e. is there is a predicate, does the subject device have the same intended use and technological characteristics. If there are different technological characteristics, do they raise"new types" of questions of safety and effectiveness? If FDA review staff believe s you do not meet these 510(k) criteria, they send a letter stating that they have not reviewed the file substantively be cause FDA believes you do not (may not) qualify for the 510(k) pathway.

  • CMS Publishes Proposed Rule For Physician Payment Sunshine Act

    • Authored by: Mark DuVal
    • Published on: December 20, 2011
    Important News
    CMS finally published a Proposed Rule for the Physician Payment Sunshine Act (the "Act"), which was passed last year. The Proposed Rule was initially due by October 1, a deadline CMS missed.

    All 121 pages of the Proposed Rule are located here:
    https://s3.amazonaws.com/public-inspection.federalregister.gov/2011-32244.pdf

    We have attempted to break the Proposed Rule down to save you some time! Please call us if you need help preparing for the new law.

    Companies that fail to report are subject to fines ranging from $1000-10,000 per occurrence for unintentional conduct and $10,000-$100,000 for intentional conduct.
  • FDA Attempting To Rescind ReGen Clearance

    • Authored by: Mark DuVal
    • Published on: October 15, 2010

    Executive summary

    ReGen is the poster-child for FDA's never-ending attempts to tell us all how broken the 510(k) program is and how FDA will rescue society from all the bad devices out there today and in the future.

    The Agency, and in particular, CDRH Director Dr. Jeff Shuren, won't let this company go.

    On December 18, 2008, FDA granted 510(k) clearance to ReGen Biologic's Menaflex™ device. This week CDRH decided to "rescind" ReGen's clearance, although it's not clear they have the legal authority to do so. Is this a political maneuver or a new way of doing business at FDA or both?

The information on our site is not intended to provide specific legal advice.
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