The FBI investigation into power morcellators may run aground if the agency does not come across evidence of criminal behavior, but reports have surfaced that the husband of a patient had contacted the FBI office in New Jersey about the situation, while FDA declined to say whether it had been contacted by the FBI. Any pursuit of the matter based on regulatory compliance is likely to falter, however, given that FDA has not cited device makers for failure to file medical device reports under the "reasonably known" standard for MDR requirements. Read More
