FDA alerted the public on Thursday that early data from independent studies suggests potential inaccurate results from using the Abbott ID NOW point-of-care diagnostic for COVID-19. The agency has also received 15 adverse event reports about the ID NOW test that suggests some users are receiving inaccurate negative results. Abbott went on the defensive and pointed out that test outcomes depend on a number of factors, including conformity to the way the test was designed to be run. Some researchers, for example, reported transporting the samples to a central lab and running the test an hour or two after collection. That's a problem because the test is meant to be used near the patient, with the swab going directly from the patient's nose to the machine.
FDA cited Allergan for neglecting post-approval study obligations for two models of breast implants, even though both models were pulled from the market last year. FDA also cited Ideal Implant of failing to comply with good manufacturing parctices and adverse event reporting requirements. The warning letter to Implant is based on an FDA inspection earlier this year.
Even as hospitals resume elective procedures, a survey of consumers suggests that some patients may not be willing to reschedule deferred procedures until 2021 or later. The survey, conducted by Needham & Co., found that just over a quarter of respondents are hesitant to have a procedure this year because they fear exposure to COVID-19. Still, the majority of respondents said they are comfortable having an elective procedure in 2020.