The 3M Co., of St. Paul, Minn., said April 6 that it and the Trump administration have formed a plan to import more than 166 million respirator masks over “the next three months” for use by health care workers. 3M said that it and the White House are ensuring that this does not create or exacerbate any humanitarian crises in other nations, adding that the masks, which will be manufactured at 3M plants in China, will begin arriving in the month of April. The company expects to ramp up production in its U.S. facilities to 50 million units per month by June.
The U.S. FDA said the class I recall of the Imager II 5F angiography catheter from Boston Scientific Corp., of Marlborough, Mass., is due to the potential for catheter tip detachment, which could lead to embolism. Nine injuries have been reported in connection with the recall of more than 6,100 devices distributed in the U.S. between July 2018 and November 2019. The company is withdrawing each of the units in the 12 affected batch production lots.
The U.S. FDA has issued an enforcement policy for extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices in force for the duration of the public health emergency declared under Public Health Services Act Section 319 for the COVID-19 outbreak. The scope of the guidance includes three product codes for ECMO devices (QZJ, BYS and PZS), and nearly three dozen procodes for cardiopulmonary bypass devices and accessories, including DTQ for heart-lung machines. The scope of the policy excludes devices for extracorporeal carbon dioxide removal due to the inability of such systems to provide a level of oxygenation sufficient to be clinically meaningful. Sponsors can change a device’s indication to include use in a patient experiencing acute respiratory failure (cardiopulmonary bypass devices only) and changes to the dimensions of cannulae, tubing and connectors (both bypass and ECMO units). However, the policy does not extend to changes to device coating or components that could affect gas transfer/exchange properties. This policy appears at regulations.gov under docket number FDA-2020-D-1138 along with similar policies for other device types.
The U.S. FDA posted an enforcement policy for remote ophthalmic assessment and monitoring devices, which also is in force for the duration of the public emergency declaration for COVID-19. The devices are intended for the assessment or monitoring of ophthalmic parameters that may be connected to a wireless network, and some such devices may be able to apply algorithms for the purpose of generating an alert for a clinician. Among the product codes within the scope of this policy are PJZ (class II, general use ophthalmic camera), and HKX (class II tonometer). Among the changes in intended use/indications for use for ophthalmic cameras that would not trigger a need for a 510(k) filing is any change to functionality to permit at-home use rather than requiring application by a health care professional. For tonometers, sponsors will not need to obtain a 510(k) for changes that would allow for measurement of intraocular pressure.
The U.S. FDA has granted an emergency use authorization (EUA) for the COVID-19 real-time polymerase chain reaction testing kit by Gnomogen LLC, of San Diego, which is authorized for qualitative detection of nucleic acid for the SARS-CoV-2 virus. The authorization is limited to labs certified to conduct high-complexity tests under the Clinical Laboratory Improvements Act of 1988. The agency also granted EUA status for the Viracor SARS-CoV-2 assay by Viracor Eurofins Clinical Diagnostics, of Lees Summit, Mo.