Regulatory Affairs

IMDRF Releases Final UDI Guidance, Requirements for Medtech Software

Medical device companies must include all core data elements for the unique device identification database except those marked “optional,” according to the International Medical Device Regulators Forum. Data elements marked “if applicable” are mandatory in the UDID if the information appears on the product label, IMDRF adds. Read More

GAO: VA Should Expand Implants Covered by Committed-Use Contracts

Veterans Affairs medical centers should identify additional implants for coverage by VA-negotiated national committed-use contracts and set a timeline for expanding the volume of implants covered by these contracts, the General Accountability Office recommends in a new report. Read More

Medicare Paying Double Other Insurers for Penis Pumps: OIG

Aligning Medicare payment rates for vacuum erection systems with those of other insurers could have saved the government $14.4 million and beneficiaries about $3.6 million yearly over a six-year period, a new report by HHS’ Office of Inspector General concludes. Read More