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October 20, 2021updated 04 Jan 2022 10:24am

September 2021 saw a 21% drop in medical devices’ approval in the US

By Carmen

The number of medical devices gaining approval in the US in September 2021 saw a 21% decrease when compared with August 2021, according to GlobalData’s marketed products database.

The US medical devices market was worth $155.82bn in 2020 and is expected to reach $183.74bn by 2023, according to GlobalData’s analysis.


Hospital Supplies led newly approved devices in September 2021

Looking at the device sectors, Hospital Supplies held the largest share of 24% in gaining US approval during September 2021, followed by Orthopedic Devices with 12% and In Vitro Diagnostics with 9%.

As for the US medical devices market value, the Hospital Supplies market held a 17% share worth $26bn in 2020 and is expected to reach $21.94bn by 2023.


510(k) approved medical devices dominate the US market

In September 2021, the number of new medical devices entering the US market saw a decrease of 20% when compared with August 2021.

GlobalData’s database indicated that 510(k) approved medical devices entering the US market, accounted for 92% of new medical devices in September 2021, compared with 89% in the previous month.

CLIA declined by 27% in September 2021, as against 4% in August 2021. CLIA have become more common during the COVID-19 pandemic, as a speedy mechanism to bring therapeutic devices to market more quickly than the usual device approval process.


Class II devices dominated the US marketing activity for new medical devices in September 2021

During September 2021, Class II medical devices entering the market accounted for 91% of new medical devices approved in September 2021, compared with 89% in August 2021. Class I devices decreased from 9% of new device approvals in August 2021 to 6% in September 2021.

Hospital Supplies constituted the largest group of Class II devices, accounting for 20% of devices. Cardiovascular Devices topped Class III approvals at 86%. Class III devices are devices that generally pose the most risk to patients and includes implantable devices. Class I devices are of a lesser risk.


Company-developed devices lead US regulatory approvals during September 2021

Looking at the share of activity among medical device organisations, GlobalData’s database indicated that company-developed devices accounted for an 88% share of newly approved devices in the US during September 2021, while institute-developed marketed products held the remaining share.

In comparison, August 2021 saw a split of 85% in newly approved devices originating from private and public companies and 15% from institutes.


Methodology
The medical devices approval data used in this article were extracted from Medical Marketed Products Database of GlobalData’s Medical Intelligence Center. Marketed Products database covers all commercialized medical devices which are intended for diagnosis, treatment, and management of diseases/conditions/symptoms directly or indirectly. Marketed products are covered from regulatory bodies like US FDA, company websites, news releases, SEC filings etc. The information is collected by following systematic research techniques and proprietary methodology.

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