Pathways’ Picks March 25: MDR Delay; Rewriting the Rule Books

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ARTICLE SUMMARY:

The EU Medical Device Regulation finally might be heading for a delay, and all it took was a global pandemic. That news and a lot more on the latest implications for global medtech policy from COVID-19 in this week’s edition of Pathways’ Picks.

The facts on the ground are shifting multiple times per day as the world reacts and responds to the coronavirus pandemic. Here’s our latest Pathway’s Picks with a roundup of the key implications for medtech, including the major news that the European Commission is seeking a delay in implementation of the Medical Device Regulation, and an array of additional regulatory adjustments to the emergency.

Top Pick: MDR Delay in the Works

The Commission plans to officially seek a one-year delay to implementation of the Medical Device Regulation, a spokesperson confirmed March 25. The news comes a day after MedTech Europe and several members of the EU Parliament separately called for a delay of the May 26 date of MDR application to remove barriers to the EU’s pandemic response. It will ultimately be up to the European Parliament and Council to approve the postponement. The Commission says it hopes to send the proposal to lawmakers in early April.

“This will relieve pressure for national authorities and industry and it will allow them to fully focus on urgent priorities related to the coronavirus crisis,” said Stefan De Keersmaecker, a Commission spokesperson. “Vital devices needed to treat #COVID19 patients must remain available” in the EU market, Health Commissioner Stella Kyriakides tweeted March 25, in announcing the delay proposal.

Early reactions from EU medtech stakeholders are positive, but experts want to see the details of the Commission’s proposal to understand how the delay will be carried out.

FDA Leeway

More trials go remote? FDA issued guidance March 17 on conducting clinical trial trials during the pandemic, and at least one company has already signaled it is taking advantage of the agency’s encouragement to use telehealth data collection when possible. During its recent fourth-quarter earnings call, breast-implant maker Establishment Labs (ESTA) said it was adjusting the procedures for its ongoing trial to support a reconstructive indication for its Motiva implant. “One of the things that we are doing is proactively assessing and developing a plan with immediate implementation to minimize the impact and maintain the study goals,” said CEO Juan Jose Chacon-Quiros. “So we have developed a virtual follow-up visit plan in collaboration with the IRB, and this has been already communicated to the FDA.”

“The ability to substitute virtual visits for in-person follow-up ... is a major win for ESTA overall, in our view, allowing for continued progress in a trial that's critical for the company,” Joshua Jennings, an analyst with Cowen Washington Research Group, wrote in a March 23 research note. “This adjustment exemplifies the type of pragmatic change enabled by the agency's new guidance.”

Remote monitoring. FDA is allowing makers of a range of non-invasive remote monitoring devices to modify the devices to help eliminate unnecessary patient contact during the public health emergency, as long as the modification does not cause “undue risk,” according to a March 20 guidance document. Impacted devices include cardiac monitors, blood oximetry sensors, and electronic stethoscopes, among others.

FDA extends sponsor response time. Device firms have an extra 60 days to respond to hold notices sent by FDA as of March 16 for ongoing reviews of PMAs, 510(k)s, de novos, and humanitarian device exemptions, where the response due date was April 30 or before. “CDRH intends to extend this due date automatically; no extension requests are necessary to be submitted,” FDA said in a March 23 letter on COVID-19 impacts. Meanwhile CDRH encourages companies to turn in other submission types where a report or response is due, such as post-approval study reports and PMA annual reports, when possible.

No-go on email submissions. FDA also affirmed in the March 23 letter that it continues to receive and process incoming device submissions by mail at its Document Control Center. “In order to ensure the security of your information, we are generally unable to accept incoming submissions via email,” the letter notes. “In addition, existing systems have file size limitations associated with email. We are looking into electronic options other than email. We regret any delays this may cause you.” (See “The Regulatory Strain ofCOVID-19: Europe and The Americas,” Market Pathways, March 18, 2020.)

Capacity Building

Exemptions multiply. As hospitals in many countries face current or impending shortages, global regulatory agencies are stepping up assurances and policies intended to expand access to personal protective equipment (PPE) and ventilators.

In the US, FDA issued guidance March 22 granting manufacturers leeway to modify claims and functionality of current devices even if off-label. And on March 24, the agency gave instructions to manufacturers to streamline imports of PPE and OK’d use of certain filtering facepieces that are not approved by the National Institute for Occupational Health and Safety. Meanwhile, in Europe, individual countries are disclosing processes for companies to get exemptions to CE marks for PPE and ventilators following EU-wide emergency regulations rolled out in recent weeks. And Brazil issued a policy (in Portuguese) March 24 temporarily exempting companies from certain authorization and notification requirements for relevant emergency products. In all cases, authorities emphasize that other obligations, including post-market surveillance, remain in effect.

Bring in the feds. As pressure grows on the Trump administration to invoke the Defense Production Act (DPA) to compel companies to make certain emergently needed equipment, the device industry is specifically requesting that a single US government agency, such as the Federal Emergency Management Agency (FEMA), consolidate control over decisions about where ventilators in the US are allocated and by whom. AdvaMed said in a March 24 letter that device firms are facing “unprecedented demand” for ventilators, but they do not have enough information to know how best to prioritize their inventory to the many healthcare providers, as well as state governments and the strategic national stockpile, who want to purchase it. “These decisions can most effectively be made by a single federal coordinating entity that has information about possible sources of devices and the needs of individual users,” the trade groups write.

Meanwhile, FEMA chief Peter Gaynor confirmed yesterday that the administration has for the first time invoked the DPA to get its hands on 60,000 SARS-CoV-2 test kits, and it is inserting DPA language into federal contracts for acquiring masks.

Test trends. FDA has averaged one-to-two COVID-19 test Emergency Use Authorizations per day over the past week, granting a total of 16 test EUAs as of March 25, including multiple automated platform assays and one point-of-care test (Cepheid’s Xpert Xpress). In addition, FDA says it has been notified by more than 65 laboratories that they have started clinical testing with assays that have yet to gain an EUA under FDA’s COVID-19 emergency policies. FDA’s actions parallel other governments that are readjusting regulatory processes to expedite more virus tests to labs. The United Kingdom’s Medicines and Healthcare products Regulatory Agency, for instance, updated the targeted form for manufacturers to fill out to request approval to place SARS-CoV-2 tests on the market March 25.

Dates to Remember

March 29. Public comments are due to CMS on its recently opened national coverage analysis for blood-based biomarker screening for colon cancer with EpigenomicsEpi proColon.


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