COVID-19 RESOURCE CENTER

 

As MDMA continues to coordinate with various policy makers, federal and state agencies on addressing COVID-19, we also want to provide resources for medical technology innovators on the latest developments and information coming from Washington, DC and state legislatures.

Below please find important resources available to companies that can assist your efforts to manufacture, procure and/or distribute critical medical products and components during this unique time. We also provide helpful resources for companies seeking to ensure their employees are deemed essential and to address liquidity concerns. We will continue to engage policymakers on these and other issues to ensure the supply of lifesaving and life-sustaining technologies during this crisis.

MDMA has established a “COVID-19 Working Group” within our membership where we share timely and relevant information and updates, as well as hosting conference calls and webinars. Please email Emma Huther at ehuther@medicaldevices.org to JOIN THIS WORKING GROUP.

Please click the button below for additional information.


 

Important COVID-19 Actions, Announcements & Updates:


Food & Drug Administration (FDA) - FDA Resource Page

      Guidance Information on Importation of PPE & Other Devices

      FDA Communication: In Person Meetings, Processing documents, Marketing Applications, EUAs & More

      FDA Resource: Emergency Use Authorization (EUA)

      FDA COVID-19 Guidance Document Resource Page

      FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

      FDA Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices during COVID-19

      FDA Supplemental Guidance for the Automated Commercial Environment/International Trade Data System (ACE/ITDS) Version 2.5.1

      FDA Statement on Foreign & International Facility Inspections

      FDA Guidance for Non-Invasive Remote Monitoring Devices

      FDA Email Contacts:

      General mailbox for shortages: Deviceshortages@fda.hhs.gov

      National Speed Dating Service for Manufacturers: COVIDManufacturing@fda.hhs.gov

      Import issues associated with PPE: COVID19FDAIMPORTINQUIRIES@fda.hhs.gov

      Emergency use Authorization:

     IVDs: CDRH-EUA-Templates@fda.hhs.gov

     Non-IVDs: CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov

 

Centers for Medicare and Medicaid Services (CMS) - CMS Resource Page

      CMS Recommendations on Elective Surgeries & Dental Procedures

      OPEN PAYMENTS PROGRAM – COVID-19 Announcement

 

White House, CDC & Other Federal Resources

      White House Resource Page

      CDC Resource Page

      Helpful Links & Resources from other Federal Agencies

 

"Essential Employees" Activities/Continuity Business

      Sample Letter - Company Essential Employee Letter for Employees

      “Shelter in Place” Exemption Language Supported by Life Science Community

      CISA Memo - IDENTIFICATION OF ESSENTIAL CRITICAL INFRASTRUCTURE WORKERS DURING COVID-19 RESPONSE + additional information

      Federal Reserve Announcement: Liquidity measures for small, medium and large businesses

 

Business Operations & Opportunities for MDMs & Non MDMs

      FEMA Offers Ways for Private Sector to Help Fight COVID-19
      FEMA Platform - How to Help: Donations, Volunteering, Private Sector

 

Congressional Actions & Information

      CARES ACT / “Phase 3 Stimulus” (Legislative Text)

      Section-by-section breakdown of health care related provisions (including hospitals, FDA, CMS and more) (LINK)

       Breakdown of the small business relief and details on the $350B "Paycheck Protection Program," (LINK)

      Information on the $500B banking title that includes loans for distressed businesses that are ineligible for the new SBA "loans." (LINK)

 

State Government Actions & Information

      NGA Tracking of state-by-state shelter in place (SIP) orders

      NAM COVID-19 State & Regional Resources

 

International

      European Commission Seeks to Delay MDR by a Year

      COVID-19- European Commission's recommendation on conformity assessment and market surveillance procedures