Pathways’ Pick of the Week: Coronavirus Cancellations and Preparations

[Check out Market Pathways recent “From the Expert” column with tips on pursuing an Emergency Use Authorization with the FDA. Also go to Pathways for a complete roundup of medtech policy happenings and a deeper analysis of the sector.]

The global regulatory community is not running business as usual amid the persisting coronavirus outbreak. That fact was underscored this week in the medtech space by the decision from the International Medical Device Regulators Forum to cancel its upcoming meetings in Singapore. The sessions were not scheduled to take place until mid-March, but IMDRF says it decided to cancel “in view of the evolving circumstances due to the COVID-19 outbreak.” Singapore has reported more cases of coronavirus than any other country outside of China.

IMDRF had planned a cybersecurity workshop on March 16 and stakeholder and management committee sessions March 17-19. The biannual gathering serves as a forum to advance and finalize policy documents that underlie global medtech harmonization initiatives. Harmonized “principles and practices” for device cybersecurity is one issue that would likely have been addressed, along with next steps toward global recognition of conformity assessment bodies. IMDRF has not said whether the meetings will be rescheduled. Under IMDRF’s biannual schedule, the next round of meetings would be expected to take place in September, also in Singapore.

The IMDRF announcement followed the latest coronavirus update from FDA, which said last Friday it is working on overdrive to get ahead of any potential product shortages, but at the same time the agency has recalled its staff from China and is currently not conducting any facility inspections in the country. For any China-based inspections scheduled for February—including routine and for-cause inspections—the agency has either postponed the visits or found “other information to inform decisions allowing the products to enter our US market,”according to FDA Commissioner Stephen Hahn. Similar postponements are likely for planned March inspections.

Even as FDA finds alternative ways to allow products in from China, the risk of shortages grows as the virus continues to slow down manufacturing activity in China and elsewhere in Asia. Hahn said February 14 that the agency is proactively reaching out to hundreds of device and drug manufacturers to monitor for potential shortages. In parallel, FDA is seeking new authorities from Congress to require device companies to report the potential for shortages of its products, but that is not likely to happen in the short term.

Other coronavirus medtech updates to watch:

• First CE mark: On February 17, UK- and France-based diagnostics firm Novacyte Group announced what it believes is the first EU CE mark for a COVID-19 diagnostic test. Novacyte says its assay is being formally evaluated by public health authorities from five countries to potentially support their national screening requirements. The company also says it is pursuing an Emergency Use Authorization with FDA, using its CE mark data to help support the process.
• CDC test hiccup: Last week, the US Centers for Disease Control & Prevention disclosed some challenges in the roll out of its COVID-19 assay, which was the first to gain an FDA EUA February 4. State labs that were shipped the test reported “some inconclusive laboratory results” during quality control testing, Nancy Messonnier, director of the CDC's National Center for Immunization and Respiratory Diseases, said during a press briefing on February 12, adding “We’re looking into all of these issues to understand what went wrong, and to prevent these same things from happening in the future.” 
• Reimbursement code: On February 13, the Centers for Medicare and Medicare Services said it had established a new Healthcare Common Procedure Coding System (HCPCS) code specific for novel coronavirus assays. “This code will allow those labs conducting the test to bill for the specific test instead of an unspecified code, which means better tracking of the public health response of this particular strain of the coronavirus to help protect people from the spread of this infectious disease,” CMS said.

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