ARTICLE SUMMARY:
It’s understandably difficult to focus on anything other than the coronavirus pandemic. But while much of the economy, and R&D, infrastructure is stalled to protect public health, not everything is on hiatus. In the latest Pathways’ Pick of the Week, a look at important non-COVID-19 medtech policy developments that you might have missed in the past week.
The world is rightly absorbed by COVID-19—both on personal and societal levels. Market Pathways is no different, analyzing the impact of the crisis on medtech policy, in the near and long term. (Check out a weekly Community Blog digest of all of Pathways’ and MedTech Strategist’s free-to-read coronavirus articles, and keep up on the weekly Pathways’ Picks roundup of news and insights).
But medtech innovation and policymaking that is not directly tied to coronavirus isn’t completely frozen. We put together a roundup to catch you up on some of these important updates you might have missed, starting in China, which is in a post-surge moment while the Western world is in the middle of it:
Real-world milestone. China’s National Medical Products Administration recently announced its first-ever device approval based on in-country real-world evidence for an Allergan plc drainage device to treat open-angle glaucoma. The approval resulted from a 2019-launched pilot program in China’s Hainan Province, allowing selected participants to sell new devices in the southern Chinese region in advance of NMPA approval while collecting real-world data on the device from local hospitals to support full-country approval. (See “China Gets Real on Device Data with New Guidelines, Provincial Pilot,” Market Pathways, January 21, 2020.)
China UDI open for searching. After launching its unique device identification database in December, NMPA took the next step to make it publicly searchable on March 31. The new capabilities allow device information to be queried, downloaded, and shared, for use by the public, device companies, and healthcare providers. NMPA regulations for its new UDI system took effect October 1 and the agency is currently administering a pilot program as a first implementation step for UDI that includes participation of more than 100 device companies, including multinationals and China-based firms, registering devices under UDIs for higher-risk implantable and interventional devices.
Pear preps pre-certification. Meanwhile, a milestone was reached in the US by Pear Therapeutics Inc., which gained FDA clearance for its first-of-a-kind Somryst prescription digital therapeutic for chronic insomnia. The product is innovative as the first FDA-approved software-based cognitive behavioral therapy for this indication, but, also because it is the first product reviewed through the agency’s novel Precertification pilot program for health software. As a pilot participant, Pear underwent FDA’s first-ever “excellence appraisal” last year. It then submitted a traditional 510(k) for Somryst (supported by two randomized trials). FDA reviewers assessed whether they could appropriately review the product based on just a pre-designated portion of the full 510(k), supplemented by information gleaned on Pear’s processes by the appraisal. Ultimately, the goal is for excellence appraisals to minimize product-by-product submission requirements for pre-certified companies.
Australia software. The Therapeutic Goods Administration in Australia is seeking feedback by May 13 from industry and other stakeholders in response to its proposals for appropriate policies to define what types of software can avoid TGA’s medical device regulations. It is the agency’s second go-round in seeking comments after the first attempt “indicated that there was confusion over what was considered a medical device,” TGA said. “Consequently, it was considered important to clarify this in consultation with stakeholders prior to the commencement of the regulatory changes.”
IMDRF consults. The global harmonization-focused International Medical Device Regulators Forum issued two new documents for consultation in the past week. One of them addresses “competence and training requirements” for conformity assessment bodies, a follow-up a document on “assessment methods” issued earlier in March. The other IMDRF draft guideline outlines classification principles for in vitro diagnostics. Comments on both are due May 26.
Presbyopia panel. While FDA is canceling multiple near-term advisory panel meetings amid COVID-19 social distancing, it is hopefully looking ahead. This week, the agency scheduled a June 9 meeting of its Ophthalmic Devices Panel in Gaithersburg, MD, to discuss Refocus Group Inc.’s PMA for its Visibility Micro Insert for bilateral scleral implantation to improve unaided near vision in phakic, presbyopic patients.
FDA appeals guidance. The agency updated its existing guidance document on the Center for Devices and Radiological Health appeals process to clarify how to request a “substantive summary” of the rationale for an FDA decision.
AFib screening. The US Preventive Services Task Force opened up a public comment period through April 22 on its draft research plan for evaluating the evidence for atrial fibrillation screening with electrocardiography.
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