The FDA is working around the clock to help increase the availability of ventilators and accessories for the U.S. market. Specifically, the FDA has published an Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance.
The FDA has also issued an “umbrella” Emergency Use Authorization (EUA) that authorizes the emergency use of certain ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as "ventilators"), ventilator tubing connectors, and ventilator accessories (EUA Letter of Authorization). With regard to the EUA, Appendix B contains the list of products under this authorization (Appendix B).
FDA staff are working directly with ventilator manufacturers to add models to the “umbrella” EUA to allow for their emergency use and distribution in the U.S. market, as well as to promptly issue 510(k)s for new and modified ventilators. Most additions to this “umbrella” EUA are made within days of the request from manufacturers.
On this page:
- Enforcement Policy on Ventilators (Immediately in Effect Guidance or "IIE Guidance")
- Ventilators added to the “Umbrella” Emergency Use Authorization (EUA)
- Public Availability (Open Sourcing) of Ventilator Software and Design
Q. Is FDA providing regulatory flexibility for Quality System Regulation (QSR) requirements for modified ventilators within the scope of the enforcement policy?
A. No. Manufacturers of modified ventilators within the scope of the enforcement policy must continue to comply with applicable QSR requirements.
Q. Are 510(k) submissions expedited for ventilators covered by the enforcement policy or an Emergency Use Authorization (EUA)?
A. The FDA is committed to providing timely access to critical devices to help address the COVID-19 pandemic. The FDA outlined its enforcement policy in the IIE Guidance and continues to add ventilators to the "umbrella" EUA to rapidly expand availability of certain ventilators and accessories that are not approved, cleared, or market-authorized under sections 510(k), 513(f)(2), and 515 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The FDA’s Center for Devices and Radiological Health (CDRH) will continue to adhere to the deadlines established under the FDA’s user-fee program for new and modified products submitted under section 510(k) of the FD&C Act. For products intended to address important public health issues related to COVID-19, CDRH will conduct its review as quickly as possible.
Q. What validation tests would be necessary for modified devices within the scope of the enforcement policy during the Public Health Emergency?
A. The types of validation tests that would be necessary for modifications to a device described in the enforcement policy may vary depending on device type. The FDA does not intend to object to changes being made to the already cleared indications, claims, or functionality of these devices without prior submission of a premarket notification where the modifications will not create an undue risk in light of the public health emergency. Examples of circumstances where FDA currently believes a modification would not create such undue risk are provided in the IIE Guidance. Manufacturers must document changes to their device in their device master record and change control records and make this information available to the FDA, if requested, consistent with 21 CFR 820.30 and 21 CFR 820.180. Testing consistent with FDA recognized standards for the specific device type should also be conducted, as applicable, to ensure the device meets essential performance and basic safety criteria.
Q. What regulatory flexibility does FDA intend to provide for a device under the enforcement policy described in the IIE Guidance?
A. For devices already 510(k)-cleared by the FDA to support patients with respiratory failure or respiratory insufficiency, the FDA does not intend to object to the requirement for submission of a new premarket notification (510(k)) for limited modifications to the device's cleared indications, claims, functionality, or to the hardware, software, or materials.
Q. What are rules for registering and listing new manufacturing sites covered by the IIE Guidance?
A. Existing Registration and Listing requirements continue to be in effect under the IIE Guidance.
Q. Are 510(k) submissions expedited for ventilators covered by the enforcement policy or the EUA?
A. The FDA is committed to providing timely access to critical devices to help address the COVID-19 pandemic. The FDA outlined its enforcement policy in the IIE Guidance and continues to add ventilators to the “umbrella” EUA to rapidly expand availability of certain ventilators and accessories that are not approved, cleared, or market-authorized under sections 510(k), 513(f)(2), and 515 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The FDA’s Center for Devices and Radiological Health (CDRH) will continue to adhere to the deadlines established under FDA’s user-fee program for new and modified products submitted under section 510(k) of the FD&C Act. For products intended to address important public health issues related to COVID-19, CDRH will conduct its review as quickly as possible.
Q. If I make changes to my cleared device to be submitted in an EUA, is FDA providing regulatory flexibility for third-party testing certification?
A. Wherever possible, comprehensive testing and third-party testing certification provides the best assurance that the authorized device meets certain statutory criteria for issuance or inclusion under an EUA (see section 564(c) of the FD&C Act); that is, that the device “may be effective” and that the known and potential benefits of the product, when used to diagnose, prevent, or treat the identified disease or condition, outweigh the known and potential risks of the product, among other criteria.
However, FDA understands that comprehensive testing or a declaration of conformity according to the recommended standards (as applicable) listed in the Declarations of Conformity section of Appendix A of the EUA Letter of Authorization might not be feasible in many cases during the current COVID-19 public health emergency.
In such case, the Association for the Advancement of Medical Instrumentation (AAMI) has generated the following guidance reports that may be applicable to devices within the scope of the EUA Letter of Authorization: Emergency Use Ventilator Design Guidance, Emergency Use Resuscitator System Design Guidance, and Emergency Use of CPAP/BiPAP Design Guidance and associated Disclosure and Test Report Forms. These documents provide targeted design constraints to enable rapid development of devices to deliver mechanical ventilatory support to keep pace with clinical need and provide FDA with testing information in a consistent format. These guidances identify a limited set of essential clinical, engineering, and test requirements appropriate to support safe operation.
AAMI is continuously editing and improving these documents based on public comments. If your proposed device is within the scope of the standards outlined in the AAMI guidances, please review this document and state in your EUA submission whether your device conforms to the recommended standards outlined in the AMII guidance. For any recommended design requirement or clause outlined in the AAMI guidance that your device does not conform to, please describe how your device deviates from a particular clause, provide rationale that the deviation does not pose an unreasonable risk in light of the EUA criteria, and provide any necessary risk mitigations (e.g., labeling or warning statements) for each deviation as warranted.
Q. How do I import ventilators that fall under an EUA? Am I required to register and list?
A. FDA’s issuance of the “umbrella” EUA authorizes the emergency use in health care settings of certain ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories. With regard to the EUA, Appendix B contains the list of products under the authorization (Appendix B). The EUA addresses devices that are not currently marketed in the United States.
Ventilators, ventilator tubing connectors, and ventilator accessories that are listed under Appendix B of the EUA should be transmitted under Intended Use Code (IUC) 940.000 (Compassionate Use/Emergency Use) when filing an entry. According to Section III of the EUA Letter of Authorization, registration, listing and 510(k) information is not required but should be submitted if available.
Imported FDA-cleared ventilators modified under the scope of the IIE Guidance should be transmitted with IUC 081.006 (Enforcement discretion per final guidance). Under this IUC, the Affirmations of Compliance for medical devices (such as the Registration, Listing, and Premarket numbers) are optional in Automated Commercial Environment (ACE).
Q. What happens to authorized devices added to the “umbrella” EUA after the Public Health Emergency is over?
A. This question is specifically addressed in the FDA’s Guidance, Emergency Use Authorization of Medical Products and Related Authorities ("EUA Guidance").
From the EUA Guidance: "When an EUA declaration is terminated, then any EUA(s) issued based on that declaration will no longer remain in effect… Before an EUA declaration terminates, the Secretary of HHS must provide advance notice that is sufficient to allow for the disposition of an unapproved product, and of any labeling or other information provided related to an unapproved use of an approved product (section 564(b)(3))."
The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of products during the COVID-19 pandemic is terminated under section 564(b)(2) of the FD&C Act or the EUA is revoked under section 564(g) of the FD&C Act.
FD&C Act, Section 564(b)(2)(B) DISPOSITION OF PRODUCT.—If an authorization under this section with respect to an unapproved product ceases to be effective as a result of a termination under subparagraph (A) of this paragraph, the Secretary shall consult with the manufacturer of such product with respect to the appropriate disposition of the product.
To get a device cleared or approved by the FDA so it can remain on the market after the emergency is over, sponsors of products that have been added to Appendix B of the "umbrella" EUA are encouraged to submit a pre-market submission.
Q. Can I modify my authorized ventilator under the device’s existing EUA?
A. Some changes may be permitted under the issued existing EUA, while other changes may require a new EUA. Before making a change to the product under an EUA, a firm should contact CDRH-COVID19-Ventilators@fda.hhs.gov to discuss the proposed change. In general, the Conditions of Authorization (Section IV) in the EUA Letter of Authorization provide information about what can be amended in the EUA with concurrence of FDA.
In order to further help increase the availability of ventilators, the FDA’s guidance provides regulatory flexibility for manufacturers of FDA-cleared ventilators making certain modification to address current manufacturing limitations or supply shortages, under circumstances described in the guidance.
Some entities have sought to facilitate the availability of ventilator designs and software by making them publicly available. This "open source" approach may assist some manufacturers in entering the ventilator manufacturing space. However, it may also create confusion about an individual entity’s responsibilities for the device.
See below for responses to questions that the FDA has been receiving about "open source."
Q: Who is responsible for submitting a premarket notification (510(k)) or obtaining an emergency use authorization (EUA) for a device?
A: Among others, the entity that intends to introduce a device into the US market is responsible for submitting a premarket notification to FDA (unless the device is exempt from such requirements), or during a public health emergency, ensuring an EUA is in place for the device prior to market introduction.
Q: If a company with a ventilator that has been FDA cleared or authorized makes the ventilator’s software publicly available, can I use it to develop my own ventilator?
A: You may use third-party software in your device. You will need to ensure the software is fit for the purpose for which you use it. The new ventilator would be subject to, among other things, premarket review requirements, and may be eligible to be added to the "umbrella" ventilator EUA (see EUA Letter of Authorization).
Q: If a company with a ventilator accessory that has been FDA cleared or authorized makes the software for 3D printing the ventilator accessory publicly available, can I use it to develop my own ventilator accessory?
A: You may use third-party 3D printing software files to make your device. The new ventilator accessory may be subject to, among other things, premarket review requirements, and may be eligible to be added to the “umbrella” ventilator EUA (see EUA Letter of Authorization).
Q: If I am manufacturing a ventilator using another company’s FDA-authorized software and design, am I permitted to market the device?
A: As discussed above, among others, the entity that introduces a device into interstate commerce is responsible for ensuring the appropriate authorization for emergency use or marketing authorization is in place. Contract manufacturers – those firms that manufacture devices under contract according to someone else’s specification – are not required to submit a 510(k), and may be authorized to manufacture and distribute a device under an EUA. In the absence of this arrangement, a contract manufacturer generally would need another EUA or 510(k) to make and distribute this device.
Q: How will a marketing submission leveraging open sourced software be reviewed?
A: As with all device submissions, where possible and permissible by law, the FDA leverages existing information about device design. Entities seeking marketing authorization will be asked to provide basic information about the device design and manufacturing, including their company specific information, in addition to other information such as testing or validation data, and performance information.
Q: Am I required to comply with the FDA’s Quality System regulations (21 CFR Part 820) when manufacturing a ventilator or ventilator accessory?
A. Under certain circumstances, you may not be required to comply with the FDA’s Quality System (QS) regulations. For example, if your product had been authorized under the "umbrella" ventilator EUA (see EUA Letter of Authorization), FDA has waived current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution of the authorized ventilators, ventilator tubing connectors and ventilator accessories listed in Appendix B. The Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency guidance does not outline an enforcement policy with respect to QS regulations.
If you have further questions about the applicability of FDA’s Quality System regulation to your situation, please contact the COVID Manufacturing mailbox at COVIDManufacturing@fda.hhs.gov.
Q: Why does the FDA need to review and authorize the emergency use or marketing of a device if the software and design are already publicly available?
A: In some cases, open sourced software and device design may lead to the development of unsafe or ineffective devices. Also, open source software and design that are available on the web may not have been reviewed by the FDA if they were not included in an EUA request or marketing submission. As with all medical device regulatory activities where FDA seeks to remove or reduce unnecessary burdens, FDA will only request information necessary to establish that the entity requesting the EUA or 510(k) clearance has met the required standard. The FDA will interact with applicants through the pre-EUA and EUA process to determine what information is needed for each EUA request. See: Ventilator EUA Interactive Review Template