FDA proposes reclassification of CMV assays after four years

Four years after convening an advisory committee hearing on the subject, the U.S. FDA has proposed to reclassify quantitative assay devices for cytomegalovirus DNA into class II, but will also rename these tests “quantitative CMV nucleic acid test for transplant patient management.” Advisory committee members at the Nov. 9, 2016, FDA advisory hearing unanimously backed the down-classification from class II for CMV viral load assays, including a requirement that a test’s performance be periodically evaluated to ensure reliability. The agency awarded the first PMA for an assay of this type in 2012, following which three more PMAs have been approved. No recalls have been filed for this test type (product code PAB), although eight medical device reports have been filed, but none were associated with patient injury or death. The special controls would appear in the regulation under Part 866.3180. The agency is taking comment through Nov. 17 at docket no. FDA-2016-N-2880.

Nov. 17 advisory to address FDA safety communication

The FDA said it will convene a Nov. 17 virtual public meeting regarding the agency’s communications on medical device safety. The meeting, which will run 2.5 hours, will not take up the criteria that trigger a safety communication, but will review development of these communiques along with the content and format. The meeting will include a panel discussion on methods of delivering such information and whether the information is comprehensible to the recipient. Would-be attendees should register for the meeting by 4:00 Eastern Nov. 3, as access is on a first-come/first-serve basis.

Palmetto eyes coverage of Eversense implanted CGM

Palmetto GBA, of Columbia, S.C., said it will consider coverage of the Eversense continuous glucose monitor for adults with type 1 diabetes, a draft local coverage determination (dLCD) that would align with three other Medicare administrator contractor policies. Germantown, Md.-based Senseonics Holdings Inc., announced earlier this month that the existing three LCDs are in force as of Oct. 19, while the Palmetto dLCD has a comment period ending date of Oct. 17. Palmetto also opened a draft coverage memo for percutaneous vertebral augmentation for osteoporotic vertebral compression fracture to align with other MAC coverage policies, also with an Oct. 17 comment period closing date.

USPTO launches pilot for COVID-19 drugs, devices

The U.S. Patent and Trademark Office (USPTO) launched a deferred-fee provisional patent application pilot program Sept. 17 for drugs and devices intended to combat COVID-19. Under the pilot program, applicants may defer payment of the provisional application filing fee until they file a corresponding, nonprovisional patent application. However, they must agree to have the technical subject matter disclosed in their provisional applications made publicly available on the USPTO’s website. That way, they “can contribute to the public in the fight against COVID-19 while protecting their patent rights,” the USPTO said. The pilot is open to products or processes that will require FDA approval. Certifications and requests to participate will be accepted through the next 12 months. Depending on public feedback, the effectiveness of the program, and the workload and resources needed to administer the pilot, the USPTO may extend it beyond a year. It also may expand the program’s scope beyond COVID-19 to other areas that are the focus of pioneering or rapid innovation.

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