FDA announced in March 2020, that due to the Covid-19 pandemic situation and the shortage of medical supplies, FDA USA will exempt the pre-market review requirements for PPE.

Importing & Exporting Procedures for PPE to the USA

The COVID-19 pandemic has driven a demand for personal protective equipment (PPE) for both healthcare professionals and the general public.  For U.S. importers, to avoid challenges and risks associated with the importation of PPE, there are some essential details they need to know.

Normal Application Procedures – 21CFR Subpart E

21 CFR 807 Subpart E describes requirements for a 510(k) submission. Before marketing a device, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S.

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims.

Requirements: 21 CFR Subpart E

Time Frame expectation for the Application

• FDA is committed to providing a response to manufacturers within 90 days once the application is submitted.
  • FDA will respond within 7 days to let you know if the application has been received.
  • FDA will respond to you within 15 days to let you know if all documentations are complete.
  • If the information is not complete, you will have 180 days to complete the requirements.
  • Once all documentation is complete, the final result will be provided within 90 days

 Required information

1. 1. Required information:
      • Manufacturer’s name
      • The product name & description,
      • Product classification description, such as a surgical gown or coverall.
      • Product classification number
      • If needed, provide the text describing the similar products, including similar product’s name, product name, and description
      • Contact information of the contact person in the United States.
   2.  Documentation that confirms the product meets ANSI/AAMI PB 70 standards for protective clothing risk levels.
   3. A test report demonstrating that the product meets the ANSI/AAMI PB70 standard for protective clothing.
   4. You need to provide a product sketch, photograph to assist in the product layout.  The level of protection of the product shall be indicated.
   5. You will also need to show the product’s critical zone, as well as the protection power and sewing method of the critical area.
   6. Clearly indicate which level of protection the product conforms to in the ANSI/AAMI PB70 standard
   7. Sample labels are required to clearly indicate how to use the product and the recommended use occasions.
   8. Other labels that indicate the contents, size, quantity, manufacturer’s name, manufacturing lot number, and any other label samples indicating the product contents, size, quantity, manufacturer’s name, manufacturing lot number, and any warning message, etc.
   9. A sample label certifies that the product complies with the biocompatibility and skin contact standards (ISO 109935 and ISO 1099310, etc.)
   10. Information on the sterilization of the product, including the method of sterilization, verification of completion of sterilization, and aseptic packaging.
   11.  Information on describing the high degree of similarity between the product being applied for and the approved product.

 Fees & cost

• •  The cost would be $11,594 for standard applications; $2,899 for small businesses.  (A small business is defined as a business with a turnover of less than US$100 million in the previous tax year; if the business’ previous tax year’s turnover is less than US$30 million, the fee is waived for the initial pre-listing review.)

Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

FDA has taken various steps to prevent and mitigate shortages of critical PPE.  FDA cannot compel firms to make PPE, although the agency may expedite review, enable access to unapproved devices, and exercise regulatory flexibility to reduce barriers to market entry.

Through emergency use authorization (EUA), FDA has enabled access to PPE that have not received the agency clearance (21 U.S.C. §360bbb–3).   In simple words, yes, if you are an importer for PPE during this period, you can save a lot of trouble with the paperwork!

FDA also has issued umbrella EUAs covering surgical masks, face shields, and other protective barriers that meet certain performance standards.

Because FDA modifies, revokes, and grants new EUAs as the agency deems appropriate, this In Focus is not intended to track all PPE EUAs. To further expand the availability of PPE,  FDA also has issued enforcement policies through guidance documents that further describe conditions under which entities may manufacture and distribute PPE during the COVID-19 public health emergency without complying with certain FDA requirements, such as clearance or registration.

• Regulation: Link1 & Link2
• Coverall is not listed in the “Emergency Use Authorization” (EUA) product list issued by the US Food and Drug Administration (FDA) on February 4, 2020.
• Although coverall is not listed in the EUA, the FDA announced in March 2020, that due to the Covid-19 pandemic situation and the shortage of medical supplies, FDA USA will exempt the pre-market review requirements for PPE. 
• Under normal circumstances, the FDA requires a pre-market review of the 3rd and 4th-grade PPE.

FDA announced in March 2020, that due to the Covid-19 pandemic situation and the shortage of medical supplies, FDA USA will exempt the pre-market review requirements for PPE. 

The relevant EUA conditions for protective clothing required by the FDA:

1. The Critical Zones of the protective clothing (hands, front arms, and torso Dry part) has a level of protection above 3.
2. Meet the fire protection standards of Class 1 and Class 2
3. Show that it has been disinfected and can be used in the surgical environment;
4. Have a label that accurately describes the disinfection status of the protective clothing, including information on disinfection methods and protection capabilities that meet protection level 3;
5. Labels that describe the general characteristics of the product and reduce the risk of use, such as indicating that the protective clothing has not yet been reviewed by the FDA, that products reviewed by the FDA should be preferred, and it is recommended not to use unsterilized protective clothing in the surgical environment;
6. Related products will not cause undue risks in the current public health crisis, such as marking with risk level 4 protection.

Updated Information from FDA

As part of the federal government’s continuous quality assessment of these respirators, the FDA, working with CDC’s NIOSH, conducted additional assessments and found that NIOSH’s data indicated that some of the respirators were authorized under April 3, 2020, EUA did not meet the expected performance standards. In response, the FDA revised and reissued the EUA on May 7, 2020, including revising the third eligibility criterion such that all respirators that were previously authorized only under that criterion were no longer within the scope of authorization and were accordingly removed from Appendix A unless the respirator model was authorized under one of the remaining eligibility criteria in the May 7th letter. Additionally, the FDA, in collaboration with CDC’s NIOSH, increased surveillance and sampling of all respirators imported from China. All respirator shipments from China that come into the U.S. are subject to random sampling and testing by CDC’s NIOSH to determine whether the respirator meets the expected particulate filtration standards.

On June 6, 2020, the FDA further revised the Scope of Authorization of this EUA, including, among other changes, a further revision to the eligibility criteria to provide additional specificity regarding the jurisdictions eligible for review and to remove decontaminated respirators from the scope of authorized products such that authorized respirator models listed in Appendix A are not authorized if they are decontaminated.

On October 15, 2020, the FDA reissued the EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators manufactured in China to authorize for emergency use only those respirators listed in the EUA’s Appendix A as of the date of this issuance. As of October 15, 2020, this EUA no longer includes the three eligibility criteria that were included in the previous June 6, 2020 authorization letter, meaning the FDA will no longer be reviewing requests and adding new respirator models to Appendix A based on those criteria.

Reference Link

Medtecs Medical Gowns(Isolation Gown)

AAMI Level 1 SMMS 22gsm Isolation Gown

AAMI Level 2 SMMS 25gsm Isolation Gown

AAMI Level 3 PE Isolation Gown

AAMI Level 4 PP+PE 36gsm Isolation Gown with Tape

AAMI Level 4 PP+PE 63gsm Isolation Gown with Tape

Chemo Gown

Surgical Gown

Reusable Gown

Frequently Asked Questions