Announcement on the FDA's decision to cancel the EUA review of mask applications

To all EUA applicants, partners and related colleagues of Spica:

On October 15, US time, the FDA (US Food and Drug Administration) updated the EUA on FFRs made in China (filtered facial respirators made in China).

The main updates are as follows:

1. Approval of applications for suspension of breathing apparatus

The FDA issued a decision to suspend the review of EUA application materials for FFRs made in China.

FDA will no longer add additional respirator models to Appendix A (list of authorized respirators made in China).

Reason for suspension: The American public's demand for respirators has decreased.

Implementation time: From the date of this EUA update. (October 15th, US time)

2. Issue the disposal of authorized respirators

1. The authorized model in Appendix A is still valid. The authorization period ends when this EUA is properly terminated or this EUA is revoked.

2. During the COVID-19 epidemic, the authorized products in Appendix A will continue to be expected to prevent medical personnel from contacting pathogenic biological air particles due to a shortage of respirators.

3. All authorized respirators will continue to be supervised and monitored by the FDA in accordance with the Act ("Federal Food, Drug, and Cosmetic Act").

a) The manufacturer of an authorized respirator must publish on its English website the intended use and other instructions (such as fit test, etc.) of all authorized models imported and approved for use under this EUA. In addition, the manufacturer must notify the FDA of the website address (URL) that meets this condition by e-mail to provide relevant information to the public. The manufacturer must notify the FDA of any changes to its page.

b) The manufacturer of the authorized respirator must place an English letter in the product packaging. The letter should be able to be distributed to each end-user facility (such as each hospital, etc.) that receives an authorized respirator model. This letter must include the manufacturer, model, intended use of the authorized respirator, and the website address (URL) of the manufacturer that meets condition A.

c) The manufacturer of an authorized respirator must have an adverse event reporting procedure and send a report of any adverse event that the manufacturer is aware of to the FDA.

d) The manufacturer of an authorized respirator must ensure that any records related to this EUA are kept until otherwise notified by the FDA. These records must be provided to the FDA for inspection when required by the FDA.

e) If required by the FDA, manufacturers and importers of authorized respirators must submit new production batches for testing by NIOSH or an agency designated by FDA. The FDA will sample imported respirator batches at ports of entry or storage facilities in the United States.

f) Authorized respirator manufacturers and importers shall not distribute any unqualified batches or goods. The FDA's definition of "unqualified" is: one or more of the 30 sample respirators have a filtration efficiency lower than 95%.

g) FDA may revoke the authorization of the respirator authorized by this letter in accordance with the provisions of Section 564 (g) of the Act, and send a notice of revocation to the manufacturer in accordance with the requirements of Section 564 (g) and (h) of the Act.

h) The respirator models deleted from Appendix A will be published on the EUA webpage "Respirator Model List with Revoked Authorization".

4. The promotion and promotion of authorized respirators will be supervised and controlled by the FDA.

a) All printed materials related to the use of authorized respirators, including advertising and promotional materials, should comply with the label elements listed in this EUA, the provisions and laws specified in this EUA, and applicable requirements specified in FDA regulations.

b) Any printed materials related to authorized respirators, including advertisements or promotional materials, shall not represent or imply that the product is safe or effective in preventing or treating patients during the COVID-19 pandemic.

c) All advertisements and promotional explanatory printed materials related to product use should clearly and prominently state:

I. The product has not passed FDA certification or approval.

II. The U.S. Food and Drug Administration has authorized this product under the EUA as a source of epidemic control method for the public and medical personnel to help prevent infection or disease transmission during the COVID-19 pandemic.

III. According to the provisions of Section 564(b)(1) of the Act, only when it is declared that there is a valid reason to approve the emergency use of medical devices (including substitute products for medical devices) during the COVID-19 epidemic, Its products are authorized.

Shanghai Spica Enterprise Management Consulting Co., Ltd.

October 16, 2020

Reference：https://www.fda.gov/media/136664/download