FDA updates recognized standards list
The U.S. FDA announced an updated list of internationally recognized standards for medical device performance, which includes the addition of an updated version of ISO 80601-2 for ventilator safety and performance. Two standards for biocompatibility have been updated, including ISO 10993-9 for identification and quantification of degradation products, while ASTM F1830 for preparation of blood for dynamic in vitro evaluation of blood pumps was updated to the 2019 overwrite. There were no updates or changes to the agency’s adopted standards for nanotechnology or for electromagnetic compatibility.
Advisory hearing scheduled for Transmedics’ OCS
The FDA has scheduled an April 6 advisory hearing for the PMA for the Organ Care System (OCS) by Transmedics Inc., of Andover, Mass., for the proposed indication of resuscitation, preservation and assessment of donor hearts for potential transplant. The OCS provides extracorporeal perfusion and heart monitoring for hearts in a normothermic, beating state when expected cross-clamp time is at least four hours unless the donor is aged 55 or older, in which case cross-clamp time is limited to two hours.
GAO said ‘no’ to Spartan Medical appeal
The U.S. Government Accountability Office said it dismissed a protest lodged by Spartan Medical Inc., of Rockville, Md., regarding a government solicitation for testing supplies because the company failed to file a protest in a timely manner. Spartan had responded to a Nov. 12, 2020, solicitation by the U.S. Air Force regarding supplies of rapid point-of-care testing products, which called for a production rate of as much as 1 million tests per day within four months of the award of contract. The USAF had made it known that it would handle the procurement under a prototype “other transaction type” (OTA) authority, and Spartan is said to have responded by Dec. 7 with a solution that included a product manufactured by another business entity. Spartan objected to the use of the OTA authority, but the GAO said Spartan’s complaint about the process used by the USAF was both untimely and outside the GAO’s jurisdiction.
CDC posts updates on SARS sequencing
The U.S. Centers for Disease Control and Prevention said in a March 1 update that it had received the genomic sequences of roughly 12,000 samples of the SARS-CoV-2 virus for the week ending Feb. 20, 2021, well in excess of the goal of 7,000 sequences per week although the volume of sequenced samples had reached only slightly more than 4,000 in the week ending Feb. 13. The number of sequences submitted to the GISAID program from U.S. sources totaled roughly 140,000 at the beginning of April, while approximately 55,000 sequences are deposited in the U.S. National Center for Biotechnology Information.