CDRH Seeks To Expand Public-Private Medical Device Epidemiology Network

FDA hopes the MDEpiNet post-market surveillance program will be fully functional by the end of the year. A May public meeting is planned to catalyze the effort.

CDRH Seeks To Expand Public-Private Medical Device Epidemiology Network Article preview from "The Gray Sheet"- April 9, 2012
FDA plans to reach out to the public at a meeting this May to expand its nascent public-private Medical Device Epidemiology Network and discuss models for the network to improve device surveillance.
The network, also known as MDEpiNet, has an “overall mission to bridge the gaps that we currently have in the evidence for medical devices,” said Danica Marinac-Dabic, director of CDRH’s Division of Epidemiology in the Office of Biometrics and Surveillance, in an interview.

http://www.medicaldevicestoday.com/2012/04/cdrh-seeks-to-expand-public-private-medical-device-epidemiology-network.html

FDA’s Final Risk-Benefit Guidance Excludes 510(k)s, Adds De Novo Petitions

Article preview from "The Gray Sheet"-  April 2, 2012
Device center reviewers will begin applying the guidance to incoming PMA and de novo submissions and to submissions already under review with decisions beginning on May 1.

FDA’s Final Risk-Benefit Guidance Excludes 510(k)s, Adds De Novo Petitions Article preview from "The Gray Sheet"-  April 2, 2012
FDA’s final guidance describing how the risks and benefits of devices are considered during pre-market reviews excludes 510(k)s from its scope after industry objected to inclusion of 510(k)s in draft guidance issued last summer.
Released March 27, the final guidance also includes information on risk-benefit determinations for de novo classification petitions that was not included in the August 2011 draft version.

http://www.medicaldevicestoday.com/2012/04/fdas-final-risk-benefit-guidance-excludes-510ks-adds-de-novo-petitions.html