July 2012

Draft Guidance for Industry and FDA Staff Medical Devices: The Pre-Submission Program and Meetings with FDA Staff

This FDA guidance document published on July 13, 2012 is being distributed for comment purposes only and contains nonbinding recommendations.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This provision is a response to severe industry criticism of FDA's draft guidance on...