Heather Thompson, MDO senior editor CDRH is setting its goals along with the rest of us for the new year. The agency has published and prioritized its intentions for FY2017, starting with a list of new documents it intends to release in FY2017 (A-list). It has also shared a B-list of previously-issued final guidances for […]
Center for Devices and Radiological Health (CDRH)
Diabetes: FDA panel to mull expanded indication for Dexcom G5 continuous glucose monitor
The FDA said it’s planning to convene an advisory panel in July to consider expanding the indication for the G5 mobile continuous glucose monitor made by Dexcom (NSDQ:DXCM). The Center for Devices & Radiological Health’s chemistry & toxicology panel is slated to meet July 21 to recommend whether the intended use for the Dexcom G5 should be […]
FDA mulls banning electro stim devices for treating self-injury, aggressive behavior
The FDA today proposed a ban on electrical stimulation devices used to treat self-injurious or aggressive behavior over concerns about the safety of the devices. ESDs are designed to deliver electrical shocks through electrodes attached to the skin of individuals in an attempt to reduce self-injurious or aggressive behavior, the FDA said. However evidence indicates […]
Internet petition wants Congress to oust CDRH head Shuren
A group of upset citizens are petitioning for the removal of FDA Center for Devices and Radiological Health head Dr. Jeffrey Shuren, stating dissatisfaction with the control of devices such as Bayer‘s (ETR:BAYN) Essure and power morcellators. The movement, which started as an email campaign last October in which 100s of angry individuals sent templated letters […]
Report: Independent reviewer gives FDA pass on review program improvements
On Monday, the FDA said it got a passing grade from an independent assessment group evaluating changes implemented to improve its review process management system starting in 2014. The changes were based on recommendations given as part of a separate individual assessment, performed by Booz Allen Hamilton, which was performed as part of the Medical […]
CDRH lists strategic priorities through 2017
The FDA’s Center for Devices and Radiological Health this week released a list of its strategic priorities for the upcoming year. The federal agency’s top goals for the year include establishing a national evaluation system for medical devices, partnering with patients and promoting a culture of quality and organizational excellence, according to the report. The FDA […]
CDRH cybersecurity chief speaks on issues, plans
The FDA’s center for devices and radiological health outlined its views and plans around the state of cybersecurity in the medical sector at the 2015 10x Medical Device Conference in San Diego in May. The presentation was led by director of emergency preparedness operations and medical countermeasures Suzanne Schwartz, and included discussion of current issues, […]
Exact Sciences lands 1st joint approval through FDA-CMS parallel review
Wisconsin-based Exact Sciences (NSDQ:EXAS) won landmark approval for its Cologuard home colorectal cancer test, becoming the 1st company to successfully navigate a pilot program for parallel review by both FDA and Medicare regulators.
Press Release: FDA approves first non-invasive DNA screening test for colorectal cancer
The U.S. Food and Drug Administration today approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer.
Medical device recalls for July 2014
July Summary
Class I recalls: 5
Class II recalls: 176
Class I recalls
Date Posted, Recalling Manufacturer, Trade Name/Product, Reason for Recall