Grapefruit USA Inc (GPFT)

[BennyJ]

The recommendations are not official guidance yet as they will be open to public comment for 60-days, according to CDRH head Dr. Jeffrey Shuren, who spoke to members of the media in a midday briefing.


It will not be in effect minimum for 60 days and max not yet determined based on the public comment -

No change/impact in current pending applications.

http://www.massdevice.com/news/new-device-classification-among-changes-called-510k-program-internal-fda-report

FDA unveils proposed changes to 510(K) program
August 3, 2010 by MassDevice staffThe Centers for Devices and Radiological Health releases recommendations from 510(K) working group; Announces new Class IIb device group; Creation of a Science Council chaired by Dr. William Maisel; Clarification of recission authority among list of possible changes

After 11-months of self-reflection the Centers for Devices and Radiological Health finally showed its hand on the future of the 510(K) premarket notification program, releasing several recommendations for changing the process by which more than 3,000 medical devices are brought to market.

The recommendations are not official guidance yet as they will be open to public comment for 60-days, according to CDRH head Dr. Jeffrey Shuren, who spoke to members of the media in a midday briefing