Spurred by the pandemic, the FDA authorized more novel medical devices in 2020 than it ever has in any single year. I know what you’re thinking. “Of course, new medical device approvals were off the chart because it was a pandemic year.” True, there was a significant volume of emergency use authorizations for devices to diagnose and treat COVID-19; but the flow of clearances for non-COVID-19-related devices was also unprecedented.
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. Clearly, one major reason for the spike is that the 2020 totals include not just full-blown clearance but also EUAs, which represent 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.
Meanwhile, here are the key new FDA EUAs and clearances announced in February:
New FDA Emergency Use Authorizations (EUAs) & Approvals | Manufacturer(s) | Product |
|---|
| Gravity Diagnostics + Assurance Scientific Laboratories | EUA for Everlywell COVID-19 Test Home Collection Kit DTC |
| 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 |
New CE Marks & Global Certifications Notable European CE certifications announced during the period:
NEW CE MARKINGS IN EUROPE| Manufacturer(s) | Product(s) |
|---|
| ProciseDx | Procise FCP point-of-care test for inflammatory bowel disease |
| Siemens Healthineers | CoV2Ag, a SARS-CoV-2 antigen assay |
| Cue Health | Molecular point-of-care COVID-19 test |
| PerkinElmer | PerkinElmer COVID-19 Antigen Test |
| Horiba Medical | Microsemi CRP LC-767G, a CRP hematology analyzer |
| Alveo Technologies | Be.well COVID-19 Flex Test |
| Eurofins | GSD NovaLisa SARS-CoV-2 antibody test |
| Thermo Fisher Scientific | Applied Biosystems TaqPath COVID-19 HT Kit |
| Becton Dickinson | CE for BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes expanded to include use to help manage COVID-19 patients |
| BioMérieux | Nephrocheck assay to detect kidney stress in patients at risk of acute kidney injury (AKI) |
| Roche | SARS-CoV-2 Rapid Antigen Nasal Test |
Other international clearances announced during the period:
| Manufacturer(s) | Country(ies) | Product(s) |
|---|
| Sysmex | Japan | HISCL Influenza Assay Kit |
| Verify Diagnostics | Canada | Assure Tech Ecotest COVID-19 serological rapid test |
| Roche | Canada | SARS-CoV-2 Rapid Antigen Test |
| Saladax Biomedical | Canada | 5 of firm’s MyCare Psychiatry Laboratory Assays for use in patients prescribed 6 antipsychotic drugs |
