Personal Protective Equipment EUAs alludes to protective clothing, helmets, gloves, face shields, goggles, respirators or other equipment intended to protect the wearer from injury or the spread of contamination or ailment.
To help address worries about accessibility during the COVID-19 pandemic, the FDA has given EUAs for certain PPE products including face shields, different obstructions, and respiratory protective devices, for example, respirators. Also, the FDA has given proposals and arrangements about PPE kits.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of a EUA, including an Interactive Review Template for Non-IVD Products. Additionally, the FDA has posted a Surgical Masks EUA Template for Addition to Appendix A of the Surgical Mask Umbrella EUA.
Table of Personal Protective Equipment EUAs
- Umbrella EUA for Surgical Masks
- N95 and Other Respirators EUAs
- Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Face piece Respirators (FFRs)
- Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Face piece Respirators (FFRs)
- Face Shields and Other Barrier EUAs
Umbrella EUA for Surgical Masks
On August 5, 2020, the FDA gave an umbrella crisis use approval (EUA) for certain disposable, single-utilize surgical masks in light of concerns identifying with lacking gracefully and accessibility of such masks. This EUA approves the crisis utilization of surgical masks that meet certain exhibition prerequisites for use in medical care settings by healthcare services faculty as close to personal protective equipment to give a physical hindrance to liquids and particulate materials to forestall HCP presentation to respiratory droplets and huge particles during surgical mask deficiencies coming about because of the COVID-19 pandemic. Surgical mask that have been affirmed by FDA to meet the standards under the EUA are incorporated underneath in Appendix An as approved surgical mask.
- EUA Letter of Authorization – Umbrella EUA for Surgical Masks
- Fact Sheet for Healthcare Personnel
- Appendix A: Authorized Surgical Masks
The Surgical Masks EUA Template for Addition to Appendix A can be used to provide the information requested in the EUA to the FDA.
Appendix A: Authorized Surgical Masks
The table below includes a list of surgical masks authorized by this Umbrella EUA for emergency use during the COVID-19 public health emergency.
N95 and Other Respirators EUAs (including EUAs for NISOH-Approved N95s and imported respirators)
Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Face piece Respirators (FFRs) Manufactured in China (Reissued June 6, 2020)
On April 3, 2020, the FDA gave an umbrella EUA for certain separating face-piece respirators (FFRs) that are produced in China and are not endorsed by the National Institutes of Occupational Safety and Health (NIOSH). As referenced in CDC\’s systems for streamlining respirator gracefully, different nations support respirators as indicated by nation explicit principles. These devices are assessed utilizing techniques like those utilized by NIOSH are as yet expected to give satisfactory security to medical care staff. Non-NIOSH-affirmed FFRs fabricated in China that have been affirmed by FDA to meet the measures under the EUA are incorporated beneath in Appendix A.
As a component of the administration\’s persistent quality evaluation of these respirators, the FDA, working with CDC NIOSH, led extra appraisals and found that a portion of the respirators approved under the April 3, 2020 EUA didn\’t satisfy the normal exhibition guidelines. Accordingly, the FDA modified and reissued the EUA on May 7, 2020 to among different updates; modify the third model for qualification. Furthermore, the FDA, as a team with CDC NIOSH, is expanding reconnaissance and inspecting of all respirators imported from China – all respirator shipments from China that come into the U.S. will be dependent upon irregular examining and testing by CDC NIOSH to decide if the respirator meets the normal particulate filtration principles
On June 6, 2020 the FDA further revised the Scope of Authorization of this EUA, to among other changes, further revise the third eligibility criterion, revise the second eligibility criterion, and remove decontaminated respirators from the scope of authorized products such that authorized respirators listed in Appendix A will no longer be authorized if they are decontaminated. Further explanation of the revisions can be found in the Frequently Asked Questions (FAQs) about Non-NIOSH-Approved Filtering Face piece Respirators.
Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China (Updated: September 14, 2020)
As stated in the EUA, authorized respirators should be used in accordance with CDC\’s recommendations. For the most current CDC recommendations on optimizing respirator use, please visit CDC\’s webpage: Strategies for Optimizing the Supply of N95 Respirators.
Anyone who wants to sell a device in the U.S. It is required to make the US FDA 510 k submission at least 90 days prior to offering the device for sale, even though it may have been under development or clinical investigation before that date. Change in the intended use of a device which you already have in commercial distribution. If there is a change or modification of a legally marketed device and that change could significantly affect its safety or effectiveness. Operon Strategist is FDA 510 k process consultant helps the clients to register SBU (Small Business Unit), if applicable. Take out the testing requirement of the product, creation of the dossier, resolving the queries and after completion of all the activities, the client receives the US FDA 510 k approval. We also assist with the establishment registration and device listings to make suitable the supply of medical devices in the US
