The HHS Office of Inspector General issues a favorable advisory opinion regarding a sponsor’s payment of cost-sharing amounts in a Medicare Category B IDE Clinical Study; the FDA issues guidance regarding the use of Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; the FDA seeks comments on draft guidance regarding the use of real-world evidence in medical device regulatory decision making and on draft guidance regarding the 510(k) Third Party Review Program; the manufacturer of an unapproved See more +

The HHS Office of Inspector General issues a favorable advisory opinion regarding a sponsor’s payment of cost-sharing amounts in a Medicare Category B IDE Clinical Study; the FDA issues guidance regarding the use of Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; the FDA seeks comments on draft guidance regarding the use of real-world evidence in medical device regulatory decision making and on draft guidance regarding the 510(k) Third Party Review Program; the manufacturer of an unapproved migraine treatment device enters into a False Claims Act settlement agreement; and the DOJ continues its enforcement activities in the durable medical equipment, prosthetics, orthotics, and supply space. See less -