Determining when an enhancement or improvement to an existing 510(k) cleared device requires only a letter-to-file or a new 510(k) is important. This webinar will cover the general principles behind the original (current) modifications guidance, entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device,” dated January 10, 1997 (hereinafter the “K97-1 Modifications Guidance”), and will review its analytical framework. It will then delve briefly into where the proposed 2011 guidance, entitled “Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)],” dated December 27, 2011, was headed before it was forcibly withdrawn through Congressional action. We will then cover where FDA seems to be headed with the new, not-yet-published guidance, as reflected in its January 2014 report to Congress. In that report FDA states it will continue with the K97-1 guidance with some, as yet undisclosed, improvements. Mr. DuVal will also share whether and if FDA’s in-the-trenches interface with industry on modifications issues actually comports with what it is saying publically. Finally, we will address what this will mean when FDA comes to conduct an inspection and disagrees with your letter-to-file decision.
Wednesday, April 23, 2014 11:00am - Wednesday, April 23, 2014 1:00amCategory: WebinarsOrganizer: DuValEDU
Thursday, April 3, 2014 7:00am - Thursday, April 3, 2014 5:00amCategory: SeminarsOrganizer: DoubleTree Suites, Boston
Knowing how to get your 510(k) application through FDA quickly can save millions of dollars in unnecessary time and expense. Mark DuVal, a national authority who speaks and writes frequently on the 510(k) program is in Silver Spring, Maryland at FDA two to three times a month negotiating Pre-Submission, IDE, 510(k), de novo, PMA and combination product issues, as well as planning and executing panel meetings for his clients. He has also filed a Citizen Petition with FDA trying to influence FDA’s administration of the 510(k) program.
Thursday, March 20, 2014 8:00am - Thursday, March 20, 2014 4:00amCategory: Conferences
Tracking for the Physician Payment Sunshine Act (the “Sunshine Act”) started August 1, 2013. How is your company dealing with it? The Sunshine Act will have a long lasting impact on the way drug and device companies market products to doctors. Don’t underestimate the complexity of this law and the many granular and specific interpretations it requires for your organization. Depending on company size, CMS estimates companies will have to spend tens of thousands or even hundreds of thousands each year to comply with the new law. Those in industry know those are very conservative numbers. Although the law has many critics, it is here to stay. Marketers and CEOs are trying to decide whether to pivot, or keep doing business the way they have always done. The demands of the complying with the new law will be expensive and time consuming and require a level of transparency not seen before. This seminar will help you understand the law, the current implementation interpretations and challenges and will help you prepare for a CMS audit.
Tuesday, February 11, 2014 1:00am - Tuesday, February 11, 2014 1:45amCategory: ConferencesOrganizer: MD&M
MD&M holds the largest medical device and manufacturing educational conference in the U.S., and discuss the most important changes that will impact your department over the next 12 months.