A Note to Our Exporters:
The health and safety of our employees, clients, partners and communities is our top priority. Given the developing COVID-19 outbreak, we have made some recent changes to the way we serve U.S. exporters.
Our global network of experienced trade specialists will be working virtually and is looking forward to connecting with you via email, conference call, Skype, or video conference to discuss your international business plans. To contact a trade specialist in southern Ohio please see the email addresses at the bottom or visit our list of local U.S. Export Assistance Centers.
Know that we are here for you whether you have questions about the status of an event, need to cancel a service, or are checking on the status of an export market. To learn more about our virtual services, visit Trade.gov/virtual-services.
Additional Federal Government resources are available from the Small Business Administration and EXIM Bank.
Our thoughts are with you and the global business community, and we remain firmly committed to serving the needs of U.S. exporters like you. We will continue to evaluate options to ensure we can deliver on the objectives of our mission, and that we consider the safety of all parties involved. Connect with us on social media @USCommercialSvc for our latest updates and resources.
We look forward to working with you soon.
For more information on coronavirus, please visit: coronavirus.gov.
America Makes Launches Next Phase in Response to COVID-19
Youngstown, Ohio — March 30, 2020. In collaboration with the U.S. Food and Drug Administration (FDA), the Department of Veterans’ Affairs, and the National Institutes of Health (NIH), America Makes launched the next phase of the COVID-19 Health Care Needs and Additive Manufacturing (AM) Capabilities Repository, where additive manufacturers can upload 3D print designs to be reviewed and placed on the NIH 3D Print Exchange.
Designs submitted through the America Makes design submission form in connection with NIH 3D Print Exchange, will be placed in a fast track workflow for faster review. Designs not submitted through the America Makes process may not be considered for the fast track workflow. All designs will be publicly accessible through the NIH 3D Print Exchange website with their designation.
“We have seen so much innovation throughout the additive manufacturing industry related to the COVID-19 pandemic,” said John Wilczynski, Executive Director of America Makes. “The question we’ve repeatedly been asked is 'are these products safe and reliable in a health care setting?' The design portion of the repository seeks to put clarity around that question for both manufacturers and providers. We believe it is a critical part to allowing the additive industry to effectively meet the needs of front line health care workers.” An informational webinar was held on Monday, March 30 to provide a briefing on the COVID-19 initiatives underway and a review of the AM Capabilities and Health Care Needs Repository. You can hear the recording of the program here. As the Department of Defense Manufacturing Innovation Institute for additive manufacturing, America Makes’ mission is to drive collaboration in our industry to meet the needs of the US government and manufacturing base. This mission could not be clearer today with the ongoing COVID-19 crisis and pending supply shortages throughout the US. We believe this repository will play a critical role in meeting the needs of front line health care workers now, and preparing the U.S. for crisis situations in the future.
Visit americamakes.us/covid-19 for more information about America Makes' Response to COVID-19.
U.S. Department of Homeland Security
U.S. Customs and Border Protection
Cargo Systems Messaging Service
CSMS #42168200 - Information for Filing Personal Protective Equipment and Medical Devices During COVID-19
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The U.S. Food and Drug Administration is providing an update to CSMS message 42124872 for instructions to the import community regarding the submission of entry information for personal protective equipment and certain other devices. Following the instructions below will help facilitate the import process for all; especially for products related to the Coronavirus Disease-2019 (COVID-19) public health emergency. It is in the best interest of the U.S. to facilitate and expedite the importation of products into the U.S. market that address immediate, urgent public health needs.
Non-FDA-regulated general purpose personal protective equipment (masks, respirators, gloves, etc.)
Personal protective equipment for general purpose or industrial use (that is, products that are not intended for use to prevent disease or illness) is not regulated by FDA.
For these types of products, entry information should not be transmitted to FDA. At the time of entry for these products, Importers should transmit entry information to US Customs and Border Protection (CBP) using an appropriate HTS code with no FD Flag; or using an appropriate HTS code with an FD1 flag and do a ‘disclaim’ for FDA.
Products authorized for emergency use pursuant to an Emergency Use Authorization (EUA)
When importing such products, entry information should be submitted to FDA; however reduced FDA information is required for review.
At the time of entry, Importers should transmit an Intended Use Code of 940.000: Compassionate Use/Emergency Use Device, and an appropriate FDA product code. Under this Intended Use Code, the Affirmations of Compliance for medical devices (such as the Registration, Listing, and Premarket numbers) are optional in ACE.
Below is a list of products and the appropriate product codes that are currently authorized by an EUA:
- Diagnostic tests: 83QKP, 83QKO, 83QJR
- Masks/Respirators: 80NZJ
A full list of Emergency Use Authorizations currently in place for the COVID-19 emergency is also available on FDA’s website. Please check this site regularly for current information on products authorized by an EUA.
Products regulated by FDA as a device, not authorized by an EUA, but where an enforcement discretion policy has been published in guidance.
When importing such devices, entry information should be submitted to FDA.
At the time of entry, Importers should transmit Intended Use Code 081.006: Enforcement discretion per final guidance, and an appropriate FDA product code. Under this Intended Use Code, the Affirmations of Compliance for medical devices (such as the Registration, Listing, and Premarket numbers) are optional in ACE.
Below is a listing of guidance documents that have been issued for specific products related to COVID-19, which reference applicable product codes and policy for those products:
A full list of all guidance documents related to COVID-19 is also available on FDA’s website. Please check this site regularly for current information on these and other product areas. This message will be updated to specifically include additional guidance as it becomes available.
All questions regarding these instructions, product code assistance for these products, or to resolve entry issues can be submitted to FDA at: COVID19FDAIMPORTINQUIRIES@fda.hhs.gov or 301-796-0356.
Step-by-Step instructions on how to register and list can be found on our website at: https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing.
For additional assistance with completing initial registration, firms should contact the CDRH Registration and Listing Helpdesk at reglist@cdrh.fda.gov.
For assistance with paying the annual registration user fee, firms can reach out to the User Fee Helpdesk at userfees@fda.gov.
For further information regarding entry submission requirements in the Automated Commercial Environment (ACE) system, see the FDA Supplemental Guide for ACE at https://www.cbp.gov/sites/default/files/assets/documents/2020-Mar/FDA%20Supplemental%20Guide%20Release%202.5.1%202018%200410.pdf.
As usual, FDA may request additional information on a case-by-case basis for making its final admissibility decision.
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Co-Sponsored Events
World Trade Week goes Virtual!
USMCA Key Revisions & Implementation
May 7, 2020, 9:00am-12:00pm EDT
The NAFTA replacement, known as the U.S., Mexico, Canada agreement or USMCA, has finally made its way through Congress and has been signed by the President. Many of the details surrounding implementation, including the date, remain in question. It is a certainty, that upon implementation of the USMCA, the NAFTA as we have known it for over 25 years will cease to be. The transition is expected to happen within the next year. Is your company prepared?
Join us virtually on May 7th, as trade compliance expert John D. Goodrich compares USMCA to NAFTA and highlights what will remain the same and what changes can be expected. Even if it appears your product-specific rules remain untouched by USMCA, you will find there are some subtle differences that will affect how you implement the program within your company.
Fee: $150 Register HERE
Automotive session, 1:00pm - 3:00pm EDT
Fee: $100
Because the Automotive sector will undergo the most dramatic changes, we have added an additional 2-hour afternoon session to do a deeper dive into the specific changes. However, because the morning will focus on the overall changes, we recommend that automotive companies register for both sessions. Register HERE
Come prepared to work as we delve into the commercial side of the USMCA and learn how your company needs to prepare for the new agreement.
NOTE: This seminar is structured for traffic managers, purchasing managers, plant managers, shipping/receiving personnel, compliance officers, ISO managers, sales managers/department personnel, customer service managers, or anyone that wants to be fully informed on the USMCA.
Questions? Contact Koreen.Grube@trade.gov or (414) 217-8333
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