Personal Protective Equipment Requirements

As there has been so much confusion on the importation of PPE’s, Flegenheimer International would like to provide you with the latest information on importing them. The ports have been confiscating PPEs due to improper declarations and labeling. We would like to provide you some guidance and specific requirements for each type of PPEs. We hope this will be useful information and answer any questions you may have.

Prior to importing, Flegenheimer International will need specifications, photos and labels of the PPEs. We also recommend that manufacturer obtain a foreign manufacturer’s device registration (DEV) and device listings (LST) from FDA.  The importer should also register as Device Importer (DI) with FDA. In addition, the manufacturer may also need to obtain EUA if the product is not listed under FDA and CDC’s guidelines.

To Register with FDA:https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing

To access EUA list:https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations-medical-devices#coronavirus2019

Face Mask

FDA has also established an N95 Respirators and Surgical Masks (Face Masks) website that is updated as appropriate. For import specific information, please refer to Information for Filing Personal Protective Equipment and Medical Devices During COVID-19 website.  https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19

CDC’s Personal Protective Equipment: Questions and Answers

Counterfeit Respirators / Misrepresentation of NIOSH-Approval

CDC/NIOSH’s National Personal Protective Technology Laboratory (NPPTL) has conducted international assessments for particulate filter efficiency on several non-NIOSH-approved respirators.  For more information visit the NIOSH/NPPTL website.https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html

On April 3, 2020, FDA released an updated Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, which covers a variety of masks, face shields, and respirators.  Please review this guidance document if you are importing these products. The information below provides some key points as well as import specific information. If your product does not fit into one of the categories described in the enforcement policy, the standard regulatory requirements may be verified at the time of importation. If you are unfamiliar with the general import process, you can review www.fda.gov/imports and the Medical Device Overview. If you have specific questions regarding the Enforcement Policy, please reach out to 1-888-INFO-FDA or CDRH-COVID19-SurgicalMasks@fda.hhs.gov.

https://www.fda.gov/media/136449/download

Face masks, face shields, and filtering facepiece respirators (FFRs) that are marketed to the general public for general, non-medical purposes, such as use in construction and other industrial applications that are not intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease are not regulated by FDA. Because they are not regulated products, FDA device marketing authorization is not required, and all the other requirements of the FD&C Act do not apply to manufacturers, importers, and distributors of these products. Face Masks and N95 Respirators Not Intended for a Medical Purpose are not required to be transmitted to FDA and can be disclaimed.

Registration Certificates:  The FDA does not issue Registration Certificates to medical device establishments. FDA does not certify registration and listing information for firms that have registered and listed. Registration and Listing does not denote approval or clearance of a firm or their devices.

FDA Logo:  The FDA logo is for the official use of the U.S. Food and Drug Administration (FDA) and not for use on private sector materials. Unauthorized use of the FDA logo may violate federal law and subject those responsible to civil and/or criminal liability.  For more information please refer to our FDA Logo Policy

https://www.fda.gov/about-fda/website-policies/fda-logo-policy

The table below provides the classification regulations, device type, and product code for masks covered by the Enforcement Policy

Face Masks Intended for a Medical Purpose that are NOT Intended to Provide Liquid Barrier Protection

A face mask, with or without a face shield (not including respirators), is a device that covers the user’s nose and mouth, in accordance with CDC recommendations.  FDA does not intend to object to the distribution and use of face masks (not including respirators) that are intended for a medical purpose (whether used by medical personnel or the general public), without compliance with the following regulatory requirements where the face mask does not create an undue risk in light of the public health emergency:
· Prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81,
· Registration and Listing requirements in 21 CFR 807,
· Quality System Regulation requirements in 21 CFR 820,
· Reports or corrections and removals in 21 CFR Part 806, and
· Unique Device Identification requirements in 21 CFR Part 830 and 21 CFR 801.20.

However, FDA has provided labeling information for these products which can be found in Section C pages 5 and 6 of the Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency. Please review this information to determine if your product is applicable to this guidance.

Additionally, on April 24, 2020, FDA re-issued and Emergency Use Authorization for facemasks for use by members of the general public, including health care personnel.  The re-issued letter specifically clarifies that facemasks including cloth face coverings, are authorized to be used by HCP only as source control in accordance with CDC recommendations under this EUA. The EUA does not require the manufacturer to submit a request to the FDA for emergency use authorization of face masks.    However, in addition to the requirements outlined in the Enforcement Policy, to be considered under emergency use authorization, additional conditions must be met including those outlined in the EUA letter in Section IV. Conditions of Authorization.
Face Shields

Face Shields Intended for a Medical Purpose

A face shield is a device used to protect the user’s eyes and face from bodily fluids, liquid splashes, or potentially infectious materials. FDA does not intend to object where, for the duration of the declared public health emergency, face shields are distributed and used without compliance with the following regulatory requirements, and the surgical masks do not create an undue risk in light of the public health emergency:
· Prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81,
· Registration and Listing requirements in 21 CFR 807,
· Quality System Regulations requirements in 21 CFR 820
· Reports of Correction and Removal requirements in 21 CFR 806
Unique Device Identification requirements in 21 CFR 830 and 21 CFR 801.2

However, FDA has provided labeling information for these products which can be found in Section D pages 6 of thee Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency. Please review this information to determine if your product is applicable to this guidance Please review this information to determine if your product is applicable to this guidance

Gloves, Gowns

Gowns, other apparel, and gloves that are not intended for a medical purpose, are not medical devices.  Gowns, other apparel, and gloves that are marketed to the general public for general, non-medical purposes, such as use in construction and other industrial applications should be disclaimed.

Gowns, other apparel, and gloves are medical devices regulated by the FDA when they are intended for a medical purpose, such as prevention of infectious disease transmission (including uses related to COVID-19).  When evaluating whether these products are intended for a medical purpose, among other considerations, the FDA will consider whether:
1. They are labeled or otherwise intended for use by a health care professional;
2. They are labeled or otherwise for use in a health care facility or environment: and
They include any drugs, biologics, or anti-microbial/anti-viral agents.

https://www.fda.gov/about-fda/website-policies/fda-logo-policy

Powdered Gloves, etc.:  On January 18, 2017, the FDA banned Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling.  Therefore, powdered gloves are not covered in this guidance.

https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gloves-covid-19?utm_campaign=2020-05-06%20Medical%20Gloves%20for%20COVID-19&utm_medium=email&utm_source=Eloqua

Hand Sanitizer/Disinfectants

https://www.fda.gov/media/136390/download.

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm

General information on importing drug products is included below:
Summary
1. Ensure your product was manufactured according to U.S. Good Manufacturing Practices and that it is not contaminated, adulterated, misbranded, or otherwise does not meet U.S. laws and regulations.
2. Ensure the product is an OTC drug product or if an NDA/ANDA product then is covered by the appropriate approved and/or active application.
3. Ensure the labeling meets U.S. requirements.  Also see 21 CFR 201.
4. Ensure the required firms are registered and have listed their product(s).  Also ensure the importer is a “known importer” listed in the manufacturer’s registration.
5. Ensure the product is not subject to an Import Alert https://www.fda.gov/industry/import-alerts/search-import-alerts
6. When it is time to file a Customs Entry, you may consider using a Customs Broker.
7. Hold the goods in the shipment intact until you are notified that it is okay to distribute.
8. If the FDA or another agency requests to examine the goods, please make them available for exam.
9. Once the entry has been transmitted to the FDA, you can monitor the real-time status of your shipment with your Customs entry number via ITACS at  You can also submit documents, https://itacs.fda.gov/itacs/app/welcomeToITACS.jsf submit locations for exam, and obtain Notices of FDA Action via ITACS.

Be careful with hand sanitizer sprays.

if the label shows for disinfecting surfaces it will be regulated by EPA.

https://www.epa.gov/coronavirus/why-arent-hand-sanitizers-listed-list-n

Contact Info for FDA: covid19fdaimportinquiries@fda.hhs.gov

Flegenheimer will continue to monitor and keep you posted.

NOTE: This information is current as of the date of this document, and is not, nor is it intended to be, legal advice. No amendment has been made to reflect changes in law, regulation, or policy that may have occurred since that date. You should not rely on this newsletter to decide on a legal course of action. If you would like legal advice, you need to ask your attorney.

Do you have a new commodity that needs special attention or is “information requested”? Please complete our information request form and we will contact you to discuss this in greater detail.  Click here to contact us.