FDA released a 120-page report late yesterday detailing proposed changes to the maligned 510(k) process. The report was split in two, with the first part addressing preliminary recommendations to improve the process. The second part is a separate report from a CDRH task force that evaluated how the agency incorporates new scientific information into its regulatory decision making. 
The recommendations will be open for public comment before any changes are actually made. Some of the highlights:

• FDA recommends developing guidance to clarify when other medical devices should not be used as a benchmark. The agency wants help from the public and industry to make these definitions clear.
• The agency also wants to reiterate its authority to rescind prior device approval.
• FDA recommends creating a subset of Class II medical devices that would require clinical or manufacturing data to demonstrate that they are substantially equivalent to a device already approved. Infusion pumps, which have been in the hot seat lately, would fall into this category.
• The agency proposes a new system to notify the device industry of a change in regulatory expectations if new scientific information becomes available.