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) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.
Scope & Applicability
Product Classes
4A mask that covers the user's nose and mouth used as source control
Product worn on the face for source control and particulate filtration; The product is labeled as a barrier face covering and is evaluated in accordance with 42 CFR Part 84
Subject of the enforcement policy
Subject of the enforcement policy
Stakeholders
3EUAs have helped increase availability of these devices to HCP
inform patients and HCPs about the benefits and safety of biosimilars
Users of the devices in healthcare settings
Regulatory Context
Attributes
2meets the design, leakage assessment, material, and flammability criteria
A characteristic used to categorize face masks
Identified Hazards
Hazards
1Medical purpose for which face masks are intended
Related CFR Sections (2)
- 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 →
- 21CFR807.81§ 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead 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)
- 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)
- Needlesticks - Medical Device Reporting Guidance for User Facilities, Manufacturers, and Importers (Status: Final)