Posted 12 August 2020 | By
The US Food and Drug Administration (FDA) has launched two new webpages related to medical device importation, registration and listing during the COVID-19 pandemic.
The first webpage addresses registration and listing of medical devices, answering frequently asked questions (FAQs) about what is required, and what procedures should be followed, during the pandemic.
In the question-and-answer format, FDA collates information and guidance documents pertinent to operations during the pandemic. Device-specific guidances are available for some ventilators and personal protective equipment that clarify FDA’s intent to enforce registration and listing requirements during the public health emergency.
The FAQ page also directs industry to its list of emergency use authorizations (EUAs); facilities whose devices have an EUA “should review the EUA letter of authorization to determine whether the FDA requires you to register and list,” according to the FAQ.
Facilities required to register are still required to pay annual registration user fees; the FAQ provides links and detailed instructions about fee payment, registration and listing.
Facilities are directed to the Establishment Registration & Device Listing database to ensure that their registration and listing are complete and they have received an assigned owner/operator or registration number, or a FDA Establishment Identifier number. The lag between completing the registration process and receiving a registration number may be up to 90 days, notes the FAQ.
FDA also advises that “Registration and listing may not be required for some facilities of authorized devices so purchasers may also verify whether specific medical devices have been authorized for use during the COVID-19 emergency” by checking the list of medical device EUAs issued during the public health emergency of the pandemic.
The FAQ also makes clear that facilities cannot claim “FDA certification.” A facility’s registration and listing of its devices “does not denote approval, clearance, or authorization of that facility or its medical devices.” Neither does the agency issue a license for importing medical devices, though certain importers that meet the definition of “initial importer” must register with FDA and pay appropriate fees.
The second webpage addresses FAQs regarding importing medical devices during the COVID-19 pandemic.
The FAQs on this webpage provide guidance specific to importation of National Institute of Health and Safety (NIOSH)-approved N95 respirators under an EUA specific to those devices. FDA also points importers to applicable EUAs for China-made, non-NIOSH-approved filtering facepiece respirators and those made in other countries. These latter two types of respirators must be registered and listed if so indicated in the device’s EUA letter of authorization.
The FAQs also discuss other scenarios related to mask importation, such as appropriate product codes to use for various types of masks and how respirators may be imported under the EUA for face masks. FDA clarifies that respirators may no be imported unless EUA-authorized, FDA-cleared or NIOSH-approved.
However, general purpose face masks not intended for medical purposes may be imported, and FDA need not receive entry information, though US Customs and Border Protection still should be notified per usual practice.
Also addressed by the FAQs are the procedures for importing other personal protective equipment (PPE). In many cases, a device-specific EUA will provide guidance for importation procedures; several enforcement policy guidances have also been developed for use during the public health emergency.
Devices authorized for emergency use should be filed with the Intended Use Code (IUC) for compassionate or emergency use (940.000), while medical devices falling within the scope of an enforcement policy guidance and to which the policy applies should be filed with the IUC for “enforcement discretion per final guidance” (081.006). Individual guidances should be consulted for specifics of the circumstances when FDA intends not to object to device modification, distribution or use without compliance with certain regulatory requirements – including, in some cases, registration and listing.
Direction regarding importation of sterilizers, disinfectant devices and air purifiers that fall within FDA’s enforcement purview can be found in a policy specific to these devices during the pandemic. Ventilators and other breathing apparatus may fall under a COVID-19-specific EUA for devices not currently marketed in the United States, noted the EUA.
The FAQs also give direction and provide links and IUCs for importation of thermometers, ophthalmic devices, infusion pumps and extracorporeal memgrane oxygenation and cardiopulmonary bypass devices during the COVID-19 pandemic.
The FAQs provide contact information for importers with questions, and for checking on the status of an imported device.
FAQs importation
FAQs registration and listing
The first webpage addresses registration and listing of medical devices, answering frequently asked questions (FAQs) about what is required, and what procedures should be followed, during the pandemic.
In the question-and-answer format, FDA collates information and guidance documents pertinent to operations during the pandemic. Device-specific guidances are available for some ventilators and personal protective equipment that clarify FDA’s intent to enforce registration and listing requirements during the public health emergency.
The FAQ page also directs industry to its list of emergency use authorizations (EUAs); facilities whose devices have an EUA “should review the EUA letter of authorization to determine whether the FDA requires you to register and list,” according to the FAQ.
Facilities required to register are still required to pay annual registration user fees; the FAQ provides links and detailed instructions about fee payment, registration and listing.
Facilities are directed to the Establishment Registration & Device Listing database to ensure that their registration and listing are complete and they have received an assigned owner/operator or registration number, or a FDA Establishment Identifier number. The lag between completing the registration process and receiving a registration number may be up to 90 days, notes the FAQ.
FDA also advises that “Registration and listing may not be required for some facilities of authorized devices so purchasers may also verify whether specific medical devices have been authorized for use during the COVID-19 emergency” by checking the list of medical device EUAs issued during the public health emergency of the pandemic.
The FAQ also makes clear that facilities cannot claim “FDA certification.” A facility’s registration and listing of its devices “does not denote approval, clearance, or authorization of that facility or its medical devices.” Neither does the agency issue a license for importing medical devices, though certain importers that meet the definition of “initial importer” must register with FDA and pay appropriate fees.
The second webpage addresses FAQs regarding importing medical devices during the COVID-19 pandemic.
The FAQs on this webpage provide guidance specific to importation of National Institute of Health and Safety (NIOSH)-approved N95 respirators under an EUA specific to those devices. FDA also points importers to applicable EUAs for China-made, non-NIOSH-approved filtering facepiece respirators and those made in other countries. These latter two types of respirators must be registered and listed if so indicated in the device’s EUA letter of authorization.
The FAQs also discuss other scenarios related to mask importation, such as appropriate product codes to use for various types of masks and how respirators may be imported under the EUA for face masks. FDA clarifies that respirators may no be imported unless EUA-authorized, FDA-cleared or NIOSH-approved.
However, general purpose face masks not intended for medical purposes may be imported, and FDA need not receive entry information, though US Customs and Border Protection still should be notified per usual practice.
Also addressed by the FAQs are the procedures for importing other personal protective equipment (PPE). In many cases, a device-specific EUA will provide guidance for importation procedures; several enforcement policy guidances have also been developed for use during the public health emergency.
Devices authorized for emergency use should be filed with the Intended Use Code (IUC) for compassionate or emergency use (940.000), while medical devices falling within the scope of an enforcement policy guidance and to which the policy applies should be filed with the IUC for “enforcement discretion per final guidance” (081.006). Individual guidances should be consulted for specifics of the circumstances when FDA intends not to object to device modification, distribution or use without compliance with certain regulatory requirements – including, in some cases, registration and listing.
Direction regarding importation of sterilizers, disinfectant devices and air purifiers that fall within FDA’s enforcement purview can be found in a policy specific to these devices during the pandemic. Ventilators and other breathing apparatus may fall under a COVID-19-specific EUA for devices not currently marketed in the United States, noted the EUA.
The FAQs also give direction and provide links and IUCs for importation of thermometers, ophthalmic devices, infusion pumps and extracorporeal memgrane oxygenation and cardiopulmonary bypass devices during the COVID-19 pandemic.
The FAQs provide contact information for importers with questions, and for checking on the status of an imported device.
FAQs importation
FAQs registration and listing
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Device importers' COVID questions answered by FDA - Regulatory Focus
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