Study: FDA Cardiovascular Device Decisions Often Based on Weak Research

Premarket approvals of cardiovascular devices by the U.S. Food and Drug Administration (FDA) are often based on weak studies and may be affected by bias, according to a study in the Journal of the American Medical Association.

Researchers reviewed 123 FDA summaries of safety and effectiveness for cardiovascular device approvals that received premarket approval from January 2000 to December 2007, and the journal article found that 65 percent of the devices were supported by a single study.

According to talking points by the FDA, the agency has concerns about the approach of the study, specifically that it used guidelines normally used for drugs, which paints an inaccurate picture, it said. The statement also cites five “inappropriate assumptions,” according to the FDA:

• A single pivotal study is adequate.

• A randomized, double-blind placebo-controlled study is the best design for all medical device trials.

• The length of the study is associated with the quality of the data.

• Certain endpoints are not clinically significant.

• The study uses the quality of reporting in the summary of safety and effectiveness as the measure for the strength of the evidence.

For an abstract of the study, visit http://jama.ama-assn.org/cgi/content/short/302/24/2679?home.

For view the entire study, visit http://jama.ama-assn.org/cgi/content/full/302/24/2679?home.