Description
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19). FDA is committed to providing timely guidance to support response efforts to the COVID-19 pandemic. FDA is issuing this guidance to provide its recommendations and expectations to manufacturers of devices that were issued emergency use authorizations (EUAs) related to COVID-19 to transition to normal operations when the declarations that allowed for FDA to issue EUAs under section 564 of the Federal Food, Drug, and Cosmetic Act end. FDA believes the policy set forth in this guidance will help FDA and other stakeholders transition to normal operations and processes.
Scope & Applicability
Product Classes
10Diagnostic devices with specific clinical data needs
manufacturer does not update the device labeling for these specific devices
specific lots of the molecular diagnostic test kit had a high number of false positive reports
Facility use device for respiratory support
Personal protective equipment authorized under an umbrella EUA
IVDs designed, manufactured, and used within a single site laboratory
Singleplex or multiplex IVD assays distributed under EUA
Reusable life-supporting or life-sustaining devices issued an EUA; Devices like ventilators requiring specific transition steps
Notifications of Intent for certain reusable life-supporting devices
Risk-based approach consideration for transition
Stakeholders
6Entity responsible for submitting NDINs
devices remain distributed with retail sellers
devices remain distributed with device distributors
Non-traditional manufacturer producing devices designed by an OEM
Entities that introduce devices into commercial distribution
Official who makes declarations of emergency justifying EUAs
Regulatory Context
Attributes
2Limit for continued use of distributed IVDs; devices may be used prior to the product expiration date
The date on which an EUA declaration is no longer in effect
Identified Hazards
Hazards
2Virus that causes COVID-19 and justifies emergency declarations
Potential risk requiring device modifications
Related CFR Sections (13)
- 21CFR820.1§ 820.1 Scope.
(a) Applicability. Current good manufacturing practice (CGMP) requirements are set forth in this quality management system regulation (QMSR). The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, insRead full regulation →
- 21CFR820.3§ 820.3 Definitions.
The definitions in ISO 13485 and in Clause 3 of ISO 9000 (incorporated by reference, see § 820.7 ) apply to this part, except as specified in paragraph (b) of this section, and do not affect the meaning of similar terms defined in this title.Read full regulation →
- 21CFR7.45§ 7.45 Food and Drug Administration-requested recall.
(a) The Commissioner of Food and Drugs or designee may request a firm to initiate a recall when the following determinations have been made:Read full regulation →
- 21CFR860.3§ 860.3 Definitions.
For the purposes of this part:Read full regulation →
- 21CFR807.3§ 807.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act.Read full regulation →
- 21CFR868.5160§ 868.5160 Gas machine for anesthesia or analgesia.
(a) Gas machine for anesthesia —Read full regulation →
- 21CFR868.5440§ 868.5440 Portable oxygen generator.
(a) Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).Read full regulation →
- 21CFR868.5450§ 868.5450 Respiratory gas humidifier.
(a) Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.Read full regulation →
- 21CFR868.5454§ 868.5454 High flow humidified oxygen delivery device.
(a) Identification. A high flow humidified oxygen delivery device is a prescription device that delivers high flow oxygen with humidification for patients who are suffering from respiratory distress and/or hypoxemia.Read full regulation →
- 21CFR868.5895§ 868.5895 Continuous ventilator.
(a) Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.Read full regulation →
- 21CFR868.5925§ 868.5925 Powered emergency ventilator.
(a) Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.Read full regulation →
- 21CFR807.90§ 807.90 Format of a premarket notification submission.
Each premarket notification submission pursuant to this part shall be submitted in accordance with this section. Each submission shall:Read full regulation →
- 21CFR20.61§ 20.61 Trade secrets and commercial or financial information which is privileged or confidential.
(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationRead full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-30
Medical Device Reporting/Misbranded
Insung Medical Co. Ltd.
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
See Also (8)
- Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Quality Management System Information for Certain Premarket Submission Reviews: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Suggested Format For IDE Progress Report (Status: Final)
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 300.500 *Reprocessing of Single Use* Devices (Status: Final)
- Medical Device Reporting for User Facilities (Status: Final)
- Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Final Guidance for Industry and FDA Staff (Status: Final)
- Sterilized Convenience Kits for Clinical and Surgical Use: Final Guidance for Industry (Status: Final)