Регистрация и листинг медицинских устройств во время пандемии COVID-19: часто задаваемые вопросы
Эта страница предоставляет информацию для учреждений, занимающихся медицинскими устройствами, включая владельцев и операторов мест деятельности (также называемые учреждениями на этой странице), которые занимаются производством (например, изготовление, сборка или обработка) и распределением медицинских устройств, которые авторизованы аварийными допусками к применению (EUA) или являются объектом одного из документов руководства FDA по COVID-19.
Общие сведения
В общем, большинство учреждений, которые должны зарегистрироваться в FDA, также обязаны перечислить устройства, которые они производят, готовят, продвигают, смешивают, собирают или обрабатывают, и деятельность, которую они выполняют с такими устройствами. Если устройство требует предварительного одобрения или уведомления перед тем, как оно будет реализовано на рынке США, то владелец/оператор также должен предоставить FDA номер предварительного подачи (510(k), PMA, PDP, HDE, De Novo) при регистрации в FDA. На этой странице приводятся ответы на часто задаваемые вопросы о процедурах и требованиях, касающихся регистрации учреждений и перечня устройств во время пандемии COVID-19.
На этой странице
Вопросы и ответы
Q: Есть ли у FDA какие-либо политики или рекомендации, касающиеся регистрации и перечня для учреждений, занимающихся медицинскими устройствами, предназначенными для использования в связи с COVID-19?
A: Во время пандемии COVID-19 FDA принимает меры, чтобы обеспечить наличие критически важных медицинских устройств. Например, FDA выдала аварийные допуски к применению (EUA) для критически важных устройств, таких как некоторые насосы для вливания, устройства для удаленного мониторинга, средства индивидуальной защиты (СИЗ), такие как N95 респираторы, и ин витро-диагностика. Чтобы посмотреть EUA для конкретных устройств, см. Аварийные допуски к применению медицинских устройств для коронавирусной болезни 2019 (COVID-19). Если ваше устройство имеет EUA, вам следует ознакомиться с письмом официальной авторизации EUA, чтобы определить, требует ли FDA вашей регистрации и перечня.
Q: Как учреждение может зарегистрироваться и перечислить устройство?
A: Для пошаговых инструкций по регистрации и перечню устройств, пожалуйста, обратитесь к Руководству по регистрации и перечню. Для обучающих материалов по регистрации устройств и созданию перечня в единой системе регистрации и перечня FDA (FURLS) см.:
Q: Что произойдет, если я перечислю устройство с кодом продукта, отличающимся от описания устройства?
A: Неверно перечислять устройство с кодом продукта, не соответствующим описанию устройства. Если устройство было перечислено неправильно и известен соответствующий код продукта, пожалуйста, деактивируйте перечень для неправильного кода продукта и создайте новый перечень для правильного кода продукта.
Q: Если мое устройство еще не одобрено или утверждено и, следовательно, ему не присвоен номер предварительной подачи, как я могу его перечислить?
Руководство по регистрации и листингу FDA
Регистрация и перечисление определенных медицинских изделий для использования в связи с COVID-19
Импорт масок и СИЗ в Соединенные Штаты: нужно ли мне зарегистрироваться и внести в список?
End Further Info
I. Background
Circumstances have changed since 2020 when FDA first began issuing guidances to support COVID-19 response efforts. For example, several COVID-19 guidances were developed to help address supply chain disruptions. In several instances, supply chains have stabilized and the relevant COVID-19 guidances are no longer needed. Some COVID-19 guidances were issued to clarify previously issued recommendations by tailoring them to specific considerations for the pandemic. Because these COVID-19 guidances will not be needed when the PHE declaration expires, FDA is not extending them. In other instances, the science behind certain recommendations has advanced, and FDA may want to update certain guidances to reflect new data.
This notice addresses the 72 COVID-19-related guidance documents that are currently in effect and listed below. Most of these COVID-19-related guidances state that they are intended to remain in effect only for the duration of the COVID-19 PHE declaration. In light of HHS’s recent announcement that the PHE declaration is expected to expire on May 11, 2023, FDA has reviewed these COVID-19-related guidance documents and has examined whether any of the guidances should be continued past expiration of the PHE declaration—for example, to provide stakeholders including industry, healthcare providers, patients, consumers, and FDA time to transition from policies adopted and operations implemented during the COVID-19 PHE.
Based on this review, in this notice, FDA is announcing that the COVID-19-related guidances listed in section II, table 1 will no longer be in effect when the PHE declaration expires. FDA also is announcing that the COVID-19-related guidance documents listed in section III, table 2 of this notice are being revised to continue in effect for 180 days after the PHE declaration expires, then will no longer be in effect. The guidance documents listed in section IV, table 3 of this notice are being revised to continue in effect for 180 days after the PHE declaration expires, during which time FDA plans to further revise these guidances. Finally, this notice lists, in section V, table 4, COVID-19-related guidance documents whose intended duration is not tied to the COVID-19 PHE and that will remain in effect when the COVID-19 PHE declaration expires.
FDA’s revision of the guidances in section III, table 2 and section IV, table 3 so that they continue in effect for a brief period after expiration of the PHE declaration constitutes a minor change under 21 CFR 10.115(c)(2) and (g)(4). Even if these revisions were not minor changes, FDA has determined that obtaining comment prior to implementation is not feasible or appropriate, given the need for an orderly transition and given that the PHE declaration is anticipated to expire on May 11, 2023. Moreover, FDA already has solicited comments on these policies, through dockets for the guidances, and we have taken the comments received into account in issuing this notice. This period of time will provide an opportunity for stakeholders to transition from policies adopted and operations implemented during the COVID-19 PHE (see section III, table 2 below) or for FDA to further revise or otherwise update the guidance (see section IV, table 3 below). Although the changes to continue the guidances in section III, table 2 and section IV, table 3 for a brief period after the PHE declaration expires are being implemented immediately without prior comment, FDA will consider all comments received and revise the guidances as appropriate.
As the COVID-19 pandemic evolves, FDA continues to assess the needs and circumstances related to the policies in our COVID-19-related guidances, and we may alter our approach for individual guidances listed in this notice. For instance, FDA could withdraw a guidance before the COVID-19 PHE declaration expires should reassessment show policy reflected in a particular guidance document is no longer needed. However, should FDA alter our approach for particular guidances, we will do so consistent with our good guidance practices regulation (21 CFR 10.115).
II. COVID-19 Guidance Documents That Will No Longer Be in Effect Upon Expiration of the COVID-19 PHE Declaration
FDA has identified 22 COVID-19-related guidances that should no longer be in effect upon expiration of the COVID-19 PHE declaration. Most of these guidances state that they are intended to remain in effect only for the duration of the declared COVID-19 PHE. FDA has assessed the needs and circumstances related to the policies articulated in the 22 guidances listed in table 1. FDA also has considered comments submitted to the dockets for these guidances, and our experience with implementation. Upon review, FDA continues to believe that it is appropriate for these guidances to end when the PHE declaration expires.
While generally intended to be in effect for the duration of the COVID-19 PHE declaration, five guidances listed in table 1 also indicated that FDA expected their recommendations would continue to assist the Agency and/or stakeholders outside the expiration of the PHE declaration, otherwise reflected FDA’s current thinking, or were proposed to be extended in the draft device enforcement policy transition guidance. Start Printed Page 15419 Upon assessment of these guidances, FDA has found that these will no longer be needed because the recommendations are described in other guidance documents or the conditions related to the COVID-19 PHE as outlined in the guidances have changed and stakeholders have resumed or adjusted operations and are no longer relying on the guidances. Therefore, FDA has concluded it is appropriate for these five guidances, marked with an asterisk in table 1, to end upon expiration of the PHE declaration.
Table 1—Guidance Documents That Will No Longer Be in Effect Upon Expiration of the COVID-19 PHE Declaration
Docket No.Lead centerTitle of guidance
FDA-2020-D-1137CBERManufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency.
FDA-2020-D-1136CDERCOVID-19 Public Health Emergency Policy on COVID-19-Related Sanitation Tunnels.
FDA-2021-D-1311CDERNonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic.*
FDA-2020-D-1136CDERDevelopment of Abbreviated New Drug Applications During the COVID-19 Pandemic—Questions and Answers.
FDA-2020-D-1136CDERProtecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency.
FDA-2020-D-1136CDERReview Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry.
FDA-2020-D-1136CDERResuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency.*
FDA-2020-D-1136CDERGood Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing.*
FDA-2020-D-1136CDERStatistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency.
FDA-2020-D-1136CDERTemporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency.
FDA-2020-D-1136CDERTemporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry.
FDA-2020-D-1136CDERTemporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency.
FDA-2020-D-1136CDERTemporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency.*
FDA-2020-D-1136CDERCOVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products.
FDA-2020-D-1136CDERExemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency.4
FDA-2020-D-1138CDRHNotifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency (Revised).
FDA-2020-D-1138CDRHEnforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID-19 Public Health Emergency.*
FDA-2020-D-1139CFSANTemporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety Rule) During the COVID-19 Public Health Emergency.
FDA-2020-D-1139CFSANTemporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency.
FDA-2020-D-1139CFSANTemporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency.
FDA-2020-D-1139CFSANReporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency.
III. COVID-19 Guidance Documents That FDA Is Revising To Continue in Effect for 180 Days After the PHE Declaration Expires To Provide a Period for Stakeholder Transition
Based on our review, FDA has identified 22 COVID-19-related guidances that, similar to the guidances previously discussed, can be discontinued in connection with expiration of the COVID-19 PHE declaration but for which an additional wind-down period is appropriate to allow for an orderly transition. In general, these guidances were intended to be in effect for the duration of the declared COVID-19 PHE. However, FDA has considered the circumstances surrounding the current phase of the COVID-19 pandemic, comments submitted to the dockets for these guidances, and our experience with implementation, and has determined that for these guidances, stakeholders such as industry, healthcare providers, patients, consumers, and FDA would benefit from additional time to Start Printed Page 15420 transition from the policies adopted during the COVID-19 PHE. Thus, FDA is revising the 22 guidances listed in table 2 to continue in effect for 180 days after the expiration of the PHE declaration— i.e., after November 7, 2023, they will no longer be in effect. We note that some of these guidances are addressed in the draft device enforcement policy transition guidance, which, when finalized, may specify a duration period for these guidances that is longer than the time period described here. Therefore, the guidances listed in table 2 are being revised to reflect that they continue in effect for 180 days after the COVID-19 PHE declaration expires, with the exception of guidances covered under the draft device enforcement policy transition guidance. Those device guidances, which are identified in table 2 with an asterisk, are being revised to reflect that they continue in effect for 180 days after expiration of the PHE declaration unless a different intended duration for the guidance is set forth in the final device transition guidance.
Table 2—Guidance Documents FDA Is Revising To Continue in Effect for 180 Days After the COVID-19 PHE Declaration Expires
FDA-2020-D-1136CDERPolicy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency Guidance for Industry.
FDA-2020-D-1136CDERManufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers.
FDA-2020-D-1106CDERPolicy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals.
FDA-2020-D-1138CDRHEnforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.*
FDA-2020-D-1138CDRHEnforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.*
FDA-2020-D-1138CDRHEnforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.*
FDA-2020-D-1138CDRHEnforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.*
FDA-2020-D-1138CDRHEnforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.*
FDA-2020-D-1138CDRHEnforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.*
FDA-2020-D-1138CDRHEnforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.*
FDA-2020-D-1138CDRHEnforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.*
FDA-2020-D-1138CDRHEnforcement Policy for Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.* 5
FDA-2020-D-1138CDRHEnforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.*
FDA-2020-D-1138CDRHEnforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.*
FDA-2020-D-1138CDRHEnforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.*
FDA-2020-D-1138CDRHEnforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.*
FDA-2020-D-1138CDRHCoagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised).*
FDA-2020-D-1138CDRHEnforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised).*
FDA-2020-D-1139CFSANTemporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Retail Food Establishments During the COVID-19 Public Health Emergency.
FDA-2020-D-1139CFSANTemporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines.
FDA-2020-D-1386CFSANTemporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.
FDA-2020-D-1140CVMCVM GFI #270—Guidance on the Conduct and Review of Studies to Support New Animal Drug Development during the COVID-19 Public Health Emergency.
Start Printed Page 15421
IV. COVID-19 Guidance Documents FDA Is Revising To Continue in Effect for 180 Days After Expiration of the PHE Declaration, During Which Time FDA Plans to Further Revise the Guidances
Based on our review, FDA has identified 24 COVID-19-related guidances that we intend to retain with appropriate changes after expiration of the COVID-19 PHE declaration. Therefore, FDA is revising the 24 guidances listed in table 3 to continue in effect for 180 days after the COVID-19 PHE declaration expires. During that time, FDA plans to further revise each of these guidances with any appropriate changes based on comments received and the Agency’s experience with implementation. For example, FDA could revise a guidance so its duration aligns with an applicable declaration made under section 564 of the FD&C Act enabling the issuance of EUAs, or by removing language describing intended duration. Once a revised final guidance is issued, which could occur sooner than 180 days after the PHE declaration expires, it will supersede the guidance listed in table 3.
Table 3—Guidance Documents FDA Is Revising To Continue in Effect for 180 Days After the PHE Declaration Expires, During Which Time FDA Plans to Further Revise the Guidances
FDA-2020-D-1137CBEREmergency Use Authorization for Vaccines to Prevent COVID-19.
FDA-2020-D-1825CBERInvestigational COVID-19 Convalescent Plasma.
FDA-2015-D-1211CBERRevised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.
FDA-2020-D-1137CBERDevelopment and Licensure of Vaccines to Prevent COVID-19.
FDA-2020-D-1137CBERAlternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency.
FDA-2020-D-1106-0002CDERFDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.
FDA-2020-D-1370CDERCOVID-19: Developing Drugs and Biological Products for Treatment or Prevention.
FDA-2020-D-2016CDERPolicy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the COVID-19 Public Health Emergency (COVID-19).
FDA-2020-D-1136CDERCOVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity.
FDA-2020-D-1824CDERAssessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment.
FDA-2020-D-1414CDERInstitutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators.
FDA-2020-D-1057CDERNotifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act Guidance for Industry
FDA-2021-D-0409CDERCOVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention.
FDA-2020-D-1136CDERRemote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry.
FDA-2020-D-1136CDERCOVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for Industry.
FDA-2020-D-1136CDERDevelopment of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID 19 Public Health Emergency.
FDA-2020-D-1138CDRHEnforcement Policy for Face Masks and Barrier Face Coverings During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.6
FDA-2020-D-1138CDRHSupplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised).
FDA-2020-D-1138CDRHEnforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
FDA-2020-D-1138CDRHEnforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised).
FDA-2020-D-1139CFSANReturning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains During the COVID-19 Pandemic.
FDA-2020-D-1108CFSANTemporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency.
FDA-2020-D-1304CFSANTemporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency.
FDA-2020-D-1140CVMCVM GFI #271 Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency.
Start Printed Page 15422
V. Other COVID-19 Related Guidance Documents
FDA also has issued the four guidance documents listed in table 4 whose policies and recommendations have supported COVID-19 response efforts, but whose duration is not tied to the COVID-19 PHE declaration, and will remain in effect after expiration of the COVID-19 PHE declaration. In January 2023, FDA revised the two guidances marked with an asterisk in table 4 to state their policies are intended to remain in effect only for the duration of the declaration under section 564 of the FD&C Act by the Secretary of HHS on February 4, 2020, declaring that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV) (85 FR 7316). These guidances previously stated that they were intended to remain in effect only for the duration of the PHE declaration.
Table 4—Other COVID-19-Related Guidance Documents
FDA-2007-D-0369CDERProduct-Specific Guidances for Chloroquine and Hydroxychloroquine.
FDA-2008-D-0610CDERPostmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic.
FDA-2020-D-0987CDRHPolicy for Coronavirus Disease-2019 Tests (Revised).*
FDA-2020-D-0987CDRHPolicy for Evaluating Impact of Viral Mutations on COVID-19 Tests.*
Persons with access to the internet may obtain the guidances listed in this notice at https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders or https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
Dated: March 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
Important update: Healthcare facilities
Information for Health Departments on Reporting Cases of COVID-19
Information for Health Departments on Reporting Cases of COVID-19
CDC is reviewing this page to align with the expiration of the federal COVID-19 Public Health Emergency.
Coronavirus Disease (COVID-19) is a disease caused by the coronavirus SARS-CoV-2. COVID-19 is a nationally notifiable disease and reporting cases to CDC is supported by routine case notification through the National Notifiable Diseases Surveillance System (NNDSS), as well as resources provided through CDC’s Coronavirus and Other Respiratory Viruses Division (CORVD).
Reporting COVID-19 Cases to CDC
Please note: COVID-19 case reporting forms and templates are intended for use by health departments. Individuals or organizations with questions about reporting a case should contact their local health department.
Resources to support jurisdictional health departments submit COVID-19 case data to CDC:
Please note that the worksheet, instructions, and data dictionary were updated on May 18, 2022
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Are you planning to contribute data generated from multiple facilities?
How would you like to contribute data?
Type (and expected number) of clinical cases to contribute to WHO Global Clinical Platform
(1) Adults hospitalised with confirmed or suspected COVID-19
Expected number of cases
If you checked "yes", please indicate the expected number of cases
(2) Children hospitalised with confirmed or suspected COVID-19
(3) Multisystem Inflammatory Syndrome in Children (MIS-C)
(4) Pregnant women hospitalised with confirmed or suspected COVID-19
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All information we collect on the WHO Global Clinical database is subject to our terms of use.
By using this database, you consent to all actions taken by us with respect to your information in compliance with the terms of use.
To facilitate safe free movement during the COVID-19 pandemic, the European Union established the EU Digital COVID Certificate.
On 1 July 2023, the World Health Organization (WHO) took up the EU system of digital COVID-19 certification to establish a global system that will help protect citizens across the world from on-going and future health threats, including pandemics.
A strong tool for the reopening of our economies and societies
The EU Digital COVID certificate has been a crucial element in Europe’s response to the COVID-19 pandemic, with more than 2.3 billion certificates issued.
The certificate, which covered COVID-19 vaccination, test and recovery, facilitated safe travel for citizens, and it has also been key to support Europe’s hard-hit tourism industry.
The certificate facilitated safe travel for citizens across the European Union when Member States restricted travel on the grounds of public health. In addition, it allowed to coordinate the lifting of these restrictions from the moment it was possible. Indeed since August 2022 there have been no intra-EU travel restrictions anymore.
The EU Digital COVID Certificate has also been a success worldwide: it has set a global standard for international travel and has been the only system in operation at international level. 51 countries across four continents have benefited from this system.
The EU Digital COVID Certificate Regulation entered into application on 1 July 2021 and expired on 30 June 2023.
A step towards global health security
The WHO will facilitate this process globally under its own structure with the first use-case being the convergence of digital COVID-19 certificates. This includes taking up EU standards and validating digital signatures to prevent fraud. In doing so, WHO will not have access to any underlying personal data, which would continue to be the exclusive domain of national governments.
EU-WHO digital partnership
To facilitate the uptake of the EU Digital COVID certificate by the WHO and contribute to its operation and further development, the WHO and the European Commission have agreed to partner in digital health.
This partnership will work to technically develop the WHO system with a staged approach to cover additional use cases, which may include, for example, the digitisation of the International Certificate of Vaccination or Prophylaxis. Expanding such digital solutions will be essential to deliver better health for citizens across the globe.
The Global Digital Health Certification Network
The Global Digital Health Certification Network is a voluntary system that can help citizens to validate their health documents and use their electronic health data in a safe and secure way.
Joining the WHO Global Digital Health Certification Network is voluntary for the Member States. The Council Recommendation adopted on 27 June 2023 encourages all Member States to join the WHO system, and to continue issuing COVID-19 certificates upon request.
What is the Cochrane COVID-19 Study Register?
The Cochrane COVID-19 Study Register is a freely-available, continually-updated, annotated reference collection of human* primary studies on COVID-19, including interventional, observational, diagnostic, prognostic, epidemiological and qualitative designs.
* Note: the register does not include in-vitro study references.
The aim of the register is to support rapid evidence synthesis, including Cochrane’s work on Rapid Reviews in response to COVID-19.
Where do we source our references?
Data sources for Cochrane’s COVID-19 Study Register currently include:
We also monitor Retraction Watch. Retraction notices and expressions of concerns are added as references and linked to studies in the register.
** Search tip: To retrieve Embase.com references, conduct a search for the database name with an asterisk: Embase*
How frequently do we conduct our searches?
We search ClinicalTrials.gov daily (Monday-Friday); PubMed, Embase, ICTRP and medRxiv weekly; and CENTRAL monthly (after CENTRAL publishes at the end of each month).
Please note: while we aim to publish eligible records to the register as quickly as possible, separate searches of our sources may be needed to ensure maximum currency of search results for review production.
What are our search methods?
The PubMed strategy was designed by Robin Featherstone MLIS, Information Specialist Cochrane Central Executive Team, and peer reviewed by Douglas Salzwedel MLIS, Information Specialist and Assistant Managing Editor Cochrane Hypertension. The PubMed search was validated Aug 2020 against a "gold standard" sample of 184 known PubMed study references on COVID-19. Sensitivity was 1.0 (i.e. all references in the sample were retrieved).
The Embase.com strategy was designed by Robin Featherstone and peer reviewed by Julie Glanville MSc, Independent Consultant and Co-Convenor, Cochrane Information Retrieval Methods Group. The Embase.com strategy was validated Aug 2020 with a sensitivity of 1.0 using a sample of 177 known Embase study references on COVID-19.
CENTRAL 1 ("2019 nCoV" OR 2019nCoV OR "corona virus*" OR coronavirus* OR COVID OR COVID19 OR "nCov 2019" OR "SARS-CoV2" OR "SARS CoV-2" OR SARSCoV2 OR "SARSCoV-2"):TI,AB AND CENTRAL:TARGET2 Coronavirus:MH AND CENTRAL:TARGET3 Coronavirus:EH AND CENTRAL:TARGET4 #1 OR #2 OR #35 2019 TO 2021:YR AND CENTRAL:TARGET6 #5 AND #48 #6 NOT #7
ClinicalTrials.govCOVID-19 OR 2019-nCoV OR SARS-CoV-2 OR coronavirus
WHO ICTRPCOVID OR 2019-nCoV OR SARS-CoV-2 OR coronavirus OR corona virus
medRxivAll new medRxiv records are imported each week into the Cochrane Register of Studies. Records captured by this strategy are then evaluated:("2019 nCoV" OR 2019nCoV OR "corona virus*" OR coronavirus* OR COVID OR COVID19 OR "nCov 2019" OR "SARS-CoV2" OR "SARS CoV-2" OR SARSCoV2 OR "SARSCoV-2"):TI,AB
How do we screen our records?
Our search results are screened for eligibility by our machine learning classifier, Cochrane data curation specialists and information specialists, and volunteer citizen scientists. To assist with our screening work, please sign up for the COVID Quest! and COVID Quest Lite! tasks on Cochrane Crowd.
How do we define our study characteristics?
In January 2021, we implemented a machine learning classifier to help screen our search results. The classifier was developed, calibrated and validated using three independent datasets from the Cochrane COVID-19 Study Register. In the current workflow, records identified from PubMed and Embase are run through the classifier. Those that receive a score below the calibrated cut-point are tagged as ineligible. The remaining records are sent for manual screening. A detailed description of this workflow is available as an open-access publication:
Shemilt I, Noel-Storr A, Thomas J, Featherstone R, Mavergames C. Machine learning reduced workload for the Cochrane COVID-19 Study Register: development and evaluation of the Cochrane COVID-19 Study Classifier. Systematic Reviews. 2022 Dec;11(1):1-8. doi: 10.1186/s13643-021-01880-6
How do we evaluate the register?
We conducted an internal sensitivity evaluation of the Cochrane COVID-19 Study Register in May 2020 and a broader evaluation of the sensitivity, currency and accuracy of the register in November 2020. The November 2020 evaluation (full report and data) is available as an open-access publication:
Acknowledgements
The National Library of Medicine is the source of PubMed bibliographic records.
Embase.com records are provided under license by Elsevier. All rights are retained by the license holder.
Trial registry records are sourced from ClinicalTrials.gov and the World Health Organization’s International Clinical Trial Registry Platform (ICTRP).
medRxiv preprint records are sourced from Cold Spring Harbor Laboratory, BMJ, Yale. We acknowledge the Stephen B. Thacker CDC Library for compiling and providing the medRxiv preprint records prior to September 2021.
Our development partners are Data Language and Metaxis. We also acknowledge Ian Shemilt at the EPPI-Centre for his assistance in developing the machine learning classifier.
This work was conducted within the CEOsys project (www.covid-evidenz.de), funded under a scheme issued by the Network of University Medicine (Nationales Forschungsnetzwerk der Universitaetsmedizin (NUM)) by the Federal Ministry of Education and Research of Germany (Bundesministerium fuer Bildung und Forschung (BMBF)), grant number 01KX2021.
Notes on Modifications
Study design characteristics and controlled vocabulary descriptors are added to source records to enable advanced search features.
Terms and Conditions of Use / Disclaimer
Cochrane does not warrant or assume any legal liability or responsibility for the accuracy, completeness, or usefulness of any information, apparatus, product, or process disclosed.