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Federal device postmarket authorities are "far more extensive than for prescription drugs," and the FDA and CDRH are using their authorities to maintain continued device safety, Janet Trunzo, vice president of technology and regulatory affairs at AdvaMed, said. Read More
CDRH will, under some circumstances, allow laser product manufacturers to use alternate means to provide the required certification, identification and warning labeling without applying for or receiving approval, according to a recent guidance.
The U.S. FDA's Center for Devices and Radiological Health (CDRH) should add new "cross-cutting collaborative groups" to its structure to help the agency deal with the total product life cycles of the devices it regulates, an advisory team has recommended. Read More
A devicemaker facing potential problems after an FDA inspection would be well served by clearly and promptly corresponding with the agency, according to an FDA official speaking at an FDAnews conference last month. Read More
CDRH should add new "cross-cutting collaborative product groups" to its structure to help it deal with the total product life cycles of the devices it regulates, an advisory team has recommended.
The FDA issued two draft guidances Sept. 7 on medical testing: one covering a new type of medical test called in vitro diagnostic multivariate index assays (IVDMIAs), and the other clarifying the rules for commercially distributed active ingredients of medical tests called analyte specific reagents (ASRs).
Complaints by medical device companies, consumers and healthcare providers concerning FDA’s Center for Devices and Radiological Health (CDRH) declined for the third straight year, according to the CDRH ombudsman’s 2005 annual report.
New, real-time treatments will improve patient outcomes for prostate cancer and help lower the time and expense of more traditional radiation therapies, according to companies that have recently developed devices to enhance brachytherapy for prostate cancer.