DCLD has no wet laboratories to allow direct device testing and instead reviews data sets submitted by manufacturers based on testing by them or their clinical investigators.
DCLD handles a much smaller number of fundamentally new or high-risk PMA devices--usually 12 to 24 in the course of 1 year.
DCLD is actively involved in working with both industry and professional groups in an attempt to better incorporate these advances into our review work.
Currently, DCLD has >100 such individuals serving on four separate panels: chemistry/ toxicology, hematology/pathology, immunology, and microbiology.
Although DCLD has reviewed >20 000 IUDs in its 20-year history, premarket review of test kits or systems is not the only mechanism by which laboratory tests may be offered to healthcare providers and their patients.
The Office of Device Evaluation currently is in the process of chartering a new genetics advisory panel to provide DCLD with outside expertise to deal with genetic testing issues.