HHS examines device classification process at FDA
The U.S. Department of Health and Human Services said its decision to make permanent some of the temporary waivers for premarket notification requirements is part of a more thoroughgoing examination of “internal inconsistencies” in the FDA’s regulation of medical devices. HHS declared a number of class I and class II device types are permanently exempt from premarket notification requirements and inquired into whether a number of other device types should be as well, but noted that of the more than 6,600 product codes (procodes) in the FDA database, nearly 160 are for class I devices that require clearance under Section 510(k) of the Food, Drug and Cosmetic Act. The memo states that manual stethoscopes are exempt from premarket notification requirements, as are electronic stethoscopes labeled as lung sound monitors. Given the estimated cost of preparing and filing a 510(k) submission of $400,000 to $4 million, the net cost for one annual entry in each procode is as much as $11.2 billion. The memo is dated Jan. 8, but is date-stamped for the Federal Register as Jan. 15. HHS is taking comment through March 12, 2021.
NIH offers NGS system for SARS-CoV-2
The U.S. National Institutes of Health is offering an invention for licensing for a high-throughput in vitro diagnostic for the SARS-CoV-2 virus consisting of a massively paralleled, multiplexed screening method using next-generation sequencing. NIH said the method employs sample-specific barcoded indices that can simultaneously detect both the pathogen and the host body’s transcriptional response to infection. This method can be readily incorporated into the workings of CLIA-certified testing facilities and can “test tens of thousands of patient samples in a large bolus.” Interested parties can contact Vidita Choudhry (301-594-4095, firstname.lastname@example.org).
FDA issues pandemic policy for coagulation systems
The U.S. FDA posted a guidance for the public health emergency dealing with coagulation systems for measurement of the viscoelastic properties of whole blood, which is restricted to two device procodes. The procodes are JPA for multipurpose systems for in vitro coagulation studies and QFR for measurement of the viscoelastic properties of whole blood. Given the pressing need to appreciate the effect of the SARS-CoV-2 virus on hemocoagulation, manufacturers can make several modifications to their systems without amending existing 510(k) filings for expanded statements of use, for site of use (from hospital clinical labs to bedside inpatient settings), and any modifications to hardware or software needed to relocate such devices.