FDA overhauls 510(k) process

HealthImaging reports FDA overhauls 510(k) process:

The FDA issued two evaluations containing recommendations that address three objectives of the agency’s public health mission as it relates to medical devices--foster device innovation, create a more predictable regulatory environment and enhance device safety.

The FDA’s Center for Devices and Radiological Health (CDRH) assessment consists of two preliminary reports. One report focuses on ways to strengthen and clarify a premarket review process called the 510(k) program for medical devices that do not need to undergo a full premarket approval review. The other evaluates CDRH’s use of science in decision-making, with an eye toward adapting to new scientific information, while maintaining regulatory predictability necessary for innovation.

CDRH established two staff committees on these issues in late 2009 as part of its 2010 strategic plan, according to the agency. The committees collected and reviewed input from public meetings, open dockets, data analyses and input from CDRH staff over the course of several months to prepare the complementary evaluations.

Interesting...  we'll all read these reports with great interest, and determine the effect on the FDA's regulation of digital pathology.  Aperio and a number of other digital pathology vendors have FDA-cleared applications, all of which have gone through the FDA's 510(k) process.