News

Review of FDA's Highly-Anticipated Draft Guidance on the 510(k) Program

Commentary on regulatory and predicate requirement implications of FDA Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] by Jonathan S.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...

Draft Guidance for Industry and FDA Staff Medical Devices: The Pre-Submission Program and Meetings with FDA Staff

This FDA guidance document published on July 13, 2012 is being distributed for comment purposes only and contains nonbinding recommendations.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,...

President Signs Law Reauthorizing Drug and Device User Fees: Legislation Contains Several Important FDA Reforms

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...

What Is the Device Industry Getting for Its Money?

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This provision is a response to severe industry criticism of FDA's draft guidance on...

Proprosed Pilot Triage Program

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.

 ...

FDA ISSUES DRAFT GUIDANCE ON EVALUATING SUBSTANTIAL EQUIVALENCE IN 510(K) PREMARKET NOTIFICATIONS

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...

New FDA Draft Guidance on 510(k) program

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:

  • The FDA will continue to allow the use of multiple predicates in certain circumstances to help demonstrate SE,
  • ...

Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come

by Chris Henza and Geoff Hutchins for Medical Device and Diagnostic Industry (MDDI)

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 stated the following:

Given the release of the “The 510(k) Program” document, it is clear that FDA is standing firmly behind the 510(k) process and is...

Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]

Draft Guidance published by FDA on December 27, 2011. This guidance document is being distributed for comment purposes only. This guidance introduced the concept of primary predicate usage and excerpts from guidance document related to primary predicates are shown below:

...Section 513(i) of the FD&C Act states that for a new device to be considered substantially equivalent to a predicate device, the new device must have the same intended use as the (primary) predicate...

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