Submitted by kBLASTER Team on
by Jennifer D. Newberger – for FDA Law Blog (offical blog of Hyman, Phelps & McNamara, P.C.)
Commentary on regulatory implications of FDA Draft Guidance for Industry and Food and Drug Administration Staff - Refuse to Accept Policy for 510(k)s...
Submitted by kBLASTER Team on
This FDA guidance document published on August 13, 2012, is being distributed for comment purposes only and contains nonbinding recommendations regarding an FDA checklist for refusal to accept 510(k)s. This guidance document includes nine instances of predicate requirements within this checklist for 510(k)s, along with numerous other items on the checklist....
Submitted by kBLASTER Team on
Commentary on regulatory and predicate requirement implications of FDA Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] by Jonathan S. Kahan, Jennifer Agraz Henderson, Kelliann H. Payne for Update Magazine , The Food and Drug Law Institute, July/August 2012
Excerpts from this commentary highlights that the FDA guidance focused on...
Submitted by kBLASTER Team on
This FDA guidance document published on July 13, 2012 is being distributed for comment purposes only and contains nonbinding recommendations.
The following excerpt from the guidance document applies specifically to the issue of predicate selection:
2. Content of a Pre-Sub for a 510(k)
The Pre-Sub should contain sufficient information for FDA to provide advice to your specific questions. In addition to the information suggested in Section III of this guidance,...
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by Ropes & Gray LLP
Legal commentary on medical device regulatory developments related to Food and Drug Administration Safety and Innovation Act (FDASIA) includes a number of important provisions regarding medical devices.
Excerpt below from commentary discusses developments relevant to predicate selection:
Medical Device Regulatory Improvements: FDASIA includes a number of important provisions regarding medical devices:
Least Burdensome Standard: For 510(k)s, FDASIA clarifies that...
Submitted by kBLASTER Team on
by Morgan Lewis for JDSupra
See excerpt from commentary on Device Modifications Requiring Premarket Notification Prior to Marketing (Section 604). This is relevant to Congress revoking 2011 FDA guidance on device modifications pertinent to when it is appropriate to file new 510(k):
Device Modifications Requiring Premarket Notification Prior to Marketing (Section 604)
This provision is a response to severe industry criticism of FDA's draft guidance on...
Submitted by kBLASTER Team on
by Jim Dickinson for MDDI
Commentary on FDA decision processing times for 510(k) clearance, which found that average times for 510(k) clearance has increased from 100 days in 2005 to 161 days in 2010.
Submitted by kBLASTER Team on
FDA on April 2, 2012 released pilot program for accelerated review of 510(k) submissions to Office of In Vitro Diagnostic Device Evaluation and Safety (OVID) for submissions that meet the Quick Review criteria. OVID regulates all aspects of in-home and laboratory diagnostic tests (in vitro diagnostic devices, or IVDs). This Quick Review process is intended to clear the submission as soon as possible but within 30 days.
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Submitted by kBLASTER Team on
Commentary by Covington & Burling LLP on the regulatory and predicate requirement implications of FDA Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]. February 7, 2012.
This commentary included analysis specific to FDA guidance comments...
Submitted by kBLASTER Team on
by Vesa Janic on January 26, 2012
Commentary on regulatory and predicate requirement implications of FDA Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]. An excerpt from this commentary highlights that the FDA guidance focused on major points which include: