FDAnews Device Daily Bulletin

After Rep. John Dingell (D-Mich), chairman of the House Committee on Energy and Commerce, received a letter saying, “managers at CDRH have ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations … to make safety and effectiveness determinations that are not in accordance with scientific regulatory requirements,” Dingell and other lawmakers began an investigation into whether FDA managers “knowingly corrupted the scientific review process and approved or cleared medical device applications in gross violation of laws and regulations,” according to a statement from the committee.