Posted 06 May 2020 | By
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Wednesday issued immediately effective guidance explaining requirements for medical device makers to notify it of shortages during the coronavirus disease (COVID-19) pandemic.
Unlike drugmakers, device makers are not typically required to report shortages or discontinuances of their products to FDA; however, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) added new shortage reporting requirements for device makers.
Specifically, Section 3121 of the CARES Act amends the Federal Food, Drug, and Cosmetic Act to require device makers to notify FDA of supply interruptions or permanent discontinuations for critical devices used during a declared public health emergency or devices for which information about shortages is deemed necessary by FDA.
Manufacturers are required to provide notice at least six months ahead of the discontinuance or interruption, or as soon as practicable if providing the notice within six months is not possible.
In its guidance, FDA calls on device makers to voluntarily provide additional details beyond the requirements of the CARES Act “to better ensure FDA has the specific information it needs to help prevent or mitigate shortages during the COVID-19 public health emergency.”
FDA explains that the reporting requirements apply to the entities that hold marketing submission authorizations or are responsible for listing devices that do not require marketing submissions. However, the requirements do not apply to manufacturers distributing devices that have not yet received clearance in line with FDA guidance or enforcement discretion policies during the COVID-19 public health emergency. So far, FDA has issued relaxed enforcement policies during the COVID-19 pandemic covering a range of medical devices including diagnostics, ventilators, infusion pumps, thermometers, surgical apparel, face masks and respirators.
The guidance also provides a set of criteria for manufacturers to review to determine whether their devices are subject to the reporting requirement. Examples of such devices include ventilators and ventilator tubing, hemodialysis equipment, automated external defibrillators, cardiopulmonary bypass oxygenators, infusion pumps, diagnostic supplies and collection kits, pulse oximeters, cardiac monitoring equipment and personal protective equipment.
FDA says that manufacturers should notify it at least six months in advance of an interruption or discontinuation. If manufacturers are unable to, FDA says they should notify it no later than seven days after the interruption or discontinuation.
“With sufficient notice, FDA can work with the manufacturer and other stakeholders to potentially prevent and mitigate shortages, helping prevent negative impacts to patients and healthcare personnel,” FDA writes.
After notifying the agency of a manufacturing interruption, FDA says companies should provide updates every two weeks.
The guidance also explains what information to include in a notification and provides a sample template for manufacturers to follow.
FDA
Unlike drugmakers, device makers are not typically required to report shortages or discontinuances of their products to FDA; however, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) added new shortage reporting requirements for device makers.
Specifically, Section 3121 of the CARES Act amends the Federal Food, Drug, and Cosmetic Act to require device makers to notify FDA of supply interruptions or permanent discontinuations for critical devices used during a declared public health emergency or devices for which information about shortages is deemed necessary by FDA.
Manufacturers are required to provide notice at least six months ahead of the discontinuance or interruption, or as soon as practicable if providing the notice within six months is not possible.
In its guidance, FDA calls on device makers to voluntarily provide additional details beyond the requirements of the CARES Act “to better ensure FDA has the specific information it needs to help prevent or mitigate shortages during the COVID-19 public health emergency.”
FDA explains that the reporting requirements apply to the entities that hold marketing submission authorizations or are responsible for listing devices that do not require marketing submissions. However, the requirements do not apply to manufacturers distributing devices that have not yet received clearance in line with FDA guidance or enforcement discretion policies during the COVID-19 public health emergency. So far, FDA has issued relaxed enforcement policies during the COVID-19 pandemic covering a range of medical devices including diagnostics, ventilators, infusion pumps, thermometers, surgical apparel, face masks and respirators.
The guidance also provides a set of criteria for manufacturers to review to determine whether their devices are subject to the reporting requirement. Examples of such devices include ventilators and ventilator tubing, hemodialysis equipment, automated external defibrillators, cardiopulmonary bypass oxygenators, infusion pumps, diagnostic supplies and collection kits, pulse oximeters, cardiac monitoring equipment and personal protective equipment.
FDA says that manufacturers should notify it at least six months in advance of an interruption or discontinuation. If manufacturers are unable to, FDA says they should notify it no later than seven days after the interruption or discontinuation.
“With sufficient notice, FDA can work with the manufacturer and other stakeholders to potentially prevent and mitigate shortages, helping prevent negative impacts to patients and healthcare personnel,” FDA writes.
After notifying the agency of a manufacturing interruption, FDA says companies should provide updates every two weeks.
The guidance also explains what information to include in a notification and provides a sample template for manufacturers to follow.
FDA
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