Posted 14 August 2020 | By
For the first time, the US Food and Drug Administration (FDA) on Friday listed medical devices in shortage or that have been discontinued during the coronavirus disease (COVID-19) public health emergency using a new authority under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).
The CARES Act amended the Federal Food, Drug, and Cosmetic Act by adding Section 506J, which requires manufacturers of certain devices to notify the agency of manufacturing interruptions or permanent discontinuances that could lead to a disruption in the supply of a device during a declared public health emergency. The CARES act also requires FDA to maintain lists of devices reported to be in shortage or discontinued.
In May, FDA issued immediately effective guidance explaining the notification requirements for device makers to comply with the new shortage rules. (RELATED: CDRH explains notification requirements for device shortages under CARES Act, Regulatory Focus 6 May 2020).
Notably, the shortage list, which includes entries for devices under 20 different product codes, does not mention the specific devices or names of manufacturers. While the CARES Act calls for the list to include “The category or name of the device in shortage [and] the name of each manufacturer of such device,” FDA explains that it is not naming the devices as doing so would increase “the potential for hoarding or other disruptions in device availability to patients.”
The entries on the shortage list include various types of personal protection equipment, testing supplies and equipment and ventilation-related products. Increased demand is cited in all 20 entries, with limited supply of the devices expected for the duration of the COVID-19 public health emergency.
So far, the discontinuance list includes just one entry, for Becton Dickinson’s BodyGuard infusion pump and microsets, which the company decided to remove from the market back in April after they were recalled.
The CARES Act amended the Federal Food, Drug, and Cosmetic Act by adding Section 506J, which requires manufacturers of certain devices to notify the agency of manufacturing interruptions or permanent discontinuances that could lead to a disruption in the supply of a device during a declared public health emergency. The CARES act also requires FDA to maintain lists of devices reported to be in shortage or discontinued.
In May, FDA issued immediately effective guidance explaining the notification requirements for device makers to comply with the new shortage rules. (RELATED: CDRH explains notification requirements for device shortages under CARES Act, Regulatory Focus 6 May 2020).
Notably, the shortage list, which includes entries for devices under 20 different product codes, does not mention the specific devices or names of manufacturers. While the CARES Act calls for the list to include “The category or name of the device in shortage [and] the name of each manufacturer of such device,” FDA explains that it is not naming the devices as doing so would increase “the potential for hoarding or other disruptions in device availability to patients.”
The entries on the shortage list include various types of personal protection equipment, testing supplies and equipment and ventilation-related products. Increased demand is cited in all 20 entries, with limited supply of the devices expected for the duration of the COVID-19 public health emergency.
So far, the discontinuance list includes just one entry, for Becton Dickinson’s BodyGuard infusion pump and microsets, which the company decided to remove from the market back in April after they were recalled.
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August 15, 2020 at 04:27AM
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FDA lists medical devices in shortage under CARES authority - Regulatory Focus
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