NIST revises testing lab rules to include unannounced visits
The U.S. National Institute for Standards and Technology (NIST) said the final rule for amendment of regulations for the National Voluntary Laboratory Accreditation Program (NVLAP) includes recognition of proficiency testing as an accreditation activity. The NVLAP program is used to accredit both testing and calibration labs and is operated in accordance with the 2004 edition of ISO/IEC 17011 for accreditation bodies charged with assessment of conformity assessment bodies. The lab accreditation program uses ISO/IEC 17025 for evaluation of testing and calibration labs, which are part of the FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program. Among the revisions as part of this update is that regularly scheduled assessment visits may be supplemented by monitoring visits at any point during the accreditation period, including unannounced visits. The scope of these visits may range from a small checklist to a complete review, NIST said. The revised rule goes into effect Sept. 24.
Advamed launches site for litigation funding
The Advanced Medical Technology Association (Advamed) announced the launch of a website addressing litigation funding by outside parties, which addresses “the dangers of misleading ads for med-tech litigation.” The website includes a link to a page from the Federal Trade Commission website featuring a notice regarding advisories sent to seven legal practices in September 2019 regarding television ads that solicited clients for personal injury lawsuits. The ads are described as deceptive in that they resembled FDA safety alerts, recalls or other agency advisories “in an effort to bundle as many claims as possible for plaintiff lawyers.” The Advamed website includes information on the amount spent on litigation advertising, which fell from $8.8 million in the fourth quarter of calendar year 2019 to $4.4 million in the second quarter of 2020. Advamed also said in an emailed Sept. 23 press released that U.S. shipments of molecular diagnostic tests for the COVID-19 pandemic has now reached 160 million and that manufacturers are shipping 1.2 million tests per day.
FDA revokes umbrella EUA for infusion pumps
The U.S. FDA has revoked the umbrella emergency use authorization (EUA) for infusion pumps for the COVID-19 pandemic, which was initially opened in May 2020. The agency said no devices had been attached to the appendix for this umbrella EAU, although EUAs for individual infusion pump applications are still available. The only individual infusion pump EUA was granted to B. Braun Medical Inc., of Allentown, Pa., in April 2020 for the company’s Space and Outlook pumps.