2020 Was a Record Year for New Medical Device Approvals—And Not Just for COVID-19
They say that necessity is the mother of invention. But, historically, invention has never been the problem for creators of novel medical devices; the real challenge for these inventors has been more about getting the regulatory approval necessary to bring their creations to market. And the necessity imparted by the pandemic offered unprecedented opportunity to […]
They say that necessity is the mother of invention. But, historically, invention has never been the problem for creators of novel medical devices; the real challenge for these inventors has been more about getting the regulatory approval necessary to bring their creations to market. And the necessity imparted by the pandemic offered unprecedented opportunity to meet that challenge with the U.S. Food and Drug Administration (FDA) authorizing a record-high number of novel medical devices in 2020.
The Emergency Use Authorization Factor
Despite a slight dip in 2019, new medical device approvals have been steadily trending upward over the past decade. Even so, what occurred in 2020 represents an aberration from previous patterns, as total FDA new medical device approvals completely crushed the previous high of 2017.
Of course, the major reason for the spike is that the 2020 totals include not just full-blown clearance but also emergency use authorization (EUA), a less rigorous pathway to approval that the FDA uses in response to public health emergencies. Although this was hardly the first time that the opening of the EUA pipeline benefited medical device makers, the COVID-19 crisis was—and remains—bigger and more urgent than any previous public health emergency to arise under the FDA’s modern regulatory regime, paving the way for novel ventilators, laboratory tests, sample collection devices, personal protective equipment and other products to diagnose and treat the virus.
The Year in Device Approvals
A new article in the New England Journal of Medicine written by Jeff Shuren and William Maisel, respectively, the directors of the FDA’s Center for Devices and Radiological Health (CDRH), and the CDRH Office of Product Evaluation and Quality documents what happened. The CDRH was stretched unusually thin during the year, the authors explain, due to a deluge of submissions coming, including both COVID-19 products coming through the EUA pathway. Shuren and Maisel said the agency Shuren and Maisel said the agency issued 625 EUAs for medical devices in 2020, including several designated as novel medical devices such as in vitro diagnostics for COVID-19.
Surprisingly, though, the deluge extended beyond coronavirus. The flow of submissions for non-COVID-19 products also exceeded previous years, with device makers seeking clearance via the 510(k), Breakthrough Device and De Novo pre-market approval channels, as well as the humanitarian device exemption. Non-COVID-19 novel medical devices products that the FDA cleared for the first time in 2020 included:
- The first liquid biopsy next generation-sequencing companion diagnostic test;
- The first cardiac ultrasound software using artificial intelligence to aid in capturing quality diagnostic images;
- An automated insulin delivery and monitoring system for young patients;
- An anterior cruciate ligament implant; and
- A game-based digital therapeutic to help children with attention deficit hyperactivity disorder.
Here are some of the key new FDA EUAs and clearances announced in February:
New FDA Emergency Use Authorizations (EUAs) & Approvals
|Grifols||EUA for Procleix SARS-CoV-2 Assay|
|Immunodiagnostic Systems||EUA for IDS SARS-CoV-2 IgG automated chemiluminescent immunoassay|
|Thermo Fisher Scientific||EUA for Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit|
|Becton Dickinson||EUA for BD SARS-CoV-2/Flu assay run on firm’s BD Max platform|
|Bio-Rad||EUA for combined COVID-19, influenza A, and influenza B multiplex syndromic RT-PCR test|
|Roche||Breakthrough Device designation for Elecsys Growth Differentiation Factor-15 (GDF-15) test for use as companion diagnostic in patients with solid tumors for treatment with Pfizer’s investigational drug PF-069446860|
|Roche||510(k) clearance for Cobas BKV test expanded to include use with stabilized urine samples (previously cleared for use with ethylenediaminetetraacetic acid (EDTA) plasma samples)|
|Visby Medical||EUA for single-use, rapid point-of-care COVID-19 PCR test|
|Clinomics||EUA for TrioDx RT-PCR COVID-19 Test|
|Princeton BioMeditech||EUA for Status COVID-19/Flu antigen test|
|Siemens Healthineers||510(k) clearance for Cobas Immulite, Immulite 1000, and Immulite 2000 analyzers and immunoassays for quantitative measurement of cortisol in serum|
|Ambry Genetics||EUA for Ambry COVID-19 RT-PCR Test|
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