The Food and Drug Administration will reexamine its decision to approve Menaflex, a knee surgery device over the objections of several scientists and managers at the agency last December. The letter, signed by acting FDA Commissioner Joshua Sharfstein and reviewed by The Wall Street Journal, said the controversy over the decision raises "legitimate concerns about whether the agency's review process and decision…were compromised." Menaflex is made by ReGen Biologics Inc and is designed to help patients who have severely torn meniscus tissue in their knee joint recover long-term mobility and avoid degenerative arthritis. The House Energy and Commerce Committee asked the FDA to re-examine the ReGen decision. In a letter to the FDA, committee leaders said that agency documents "raise concerns" about an advisory panel of orthopedic-surgery experts convened by the agency. The House committee's letter cited issues "such as the exclusion of FDA experts who had raised concerns previously about the device, the propriety of ReGen's input into the selection of advisory committee members, and the failure to hold a formal vote on whether the device should be approved." FDA using a fast-track method cleared Menaflex. The fast-track method doesn't require major clinical trials on safety and efficacy. This process is under scrutiny by Congress due to allegations from FDA doctors and former FDA commissioners which it has been used too often in recent years to approve devices which need more clinical trial information. Rep. Bart Stupak (D., Mich.), has been looking into allegations involving the FDA's device division. He signed the committee's letter to the FDA along with its chairman, Henry Waxman and Frank Pallone.