 In addition, excessive regulation is blamed for the rising costs of health care and the creation of monopolies, as potential competitors are unable to get FDA approval to enter the market to compete and keep health care costs down.However, in an indicator that the FDA may be too lax in their approval process, in particular for medical devices, a 2011 study by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women and Families, and Dr. Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, showed that most medical devices recalled in the last five years for "serious health problems or death" had been previously approved by the FDA using the less stringent, and cheaper, 510(k) process.In a few cases, the devices had been deemed so low-risk that they did not need FDA regulation.