FDA Blames Staff Turnover, Poor Submissions for Approval Delays

The performance goals specified by the Medical Device User Fee Act (MDUFA) are no longer helping FDA get safe and effective medical devices to market more quickly. At an April meeting about MDUFA, which is up for reauthorization, FDA staff said that the average total time to final decision has increased, according to minutes posted online. In addition to a rise in review cycles, the agency blames industry for making poor-quality submissions and taking too long to answer requests for more information.

FDA also reported that CDRH has a much higher attrition rate than other centers, resulting in a preponderance of inexperienced reviewers and managers. The agency presented a package of proposals for reauthorizing MDUFA, including some that would address staffing concerns. The agency would establish adequate review staff, targeting bottlenecks caused by inexpert or overworked personnel. It would also establish teams of cross-cutting experts who meet routinely to ensure consistency, provide backup for one another, and develop training. Other proposals involve managing reviewers’ workloads, improving interactions, and fostering innovation. The agency says it will only review submissions that have been correctly and fully completed, as a way of improving submission quality.

FDA’s Policy Toward DTC Genetic Tests Takes Effect

CDRH has begun enforcement action against direct-to-consumer (DTC) genetic tests, issuing three new untitled letters to makers of the devices. Earlier this year, FDA staff said the center would decide on a case-by-case basis whether genetic tests could be sold directly to consumers or made available only through physicians.

The letters were sent to International Biotechnology Services, Lumigenix, and Precision Quality DNA. CDRH objected to the companies’ decisions to market the products without first obtaining approval or clearance. Lumigenix, for example, was marketing a genetic testing service intended to help consumers understand their genetic predisposition to disease conditions such as breast cancer. CDRH asked the firm to provide justification if it felt it did not need FDA’s clearance or approval.

CDRH’s regulatory approach was influenced by the Molecular and Clinical Genetics Panel of the Medical Device Advisory Committee. Earlier this year, panel members cautioned that DTC genetic tests could do more harm than good if consumers used them to predict medical risks without consulting their doctors. 

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