COVID-19 RESOURCE CENTER

 

From the start of the COVID-19 pandemic, the medical device industry has been on the front lines developing diagnostics for patients, and providing the necessary tools to protect our nation's critical health care workers. MDMA has engaged federal, state and local governments and private sector actors to provide industry assistance, and we continue to be the voice of medical technology innovators as we collectively address this crisis.

MDMA has established a “COVID-19 Working Group” within our membership where we provide timely and relevant information through conference calls, webinars and other outreach. Other COVID-19 related work streams include:

  • Liquidity Working Group
  • "Return to Work" Best Practices
  • Med Tech Representatives Access
  • And More!

If you are an MDMA member, please contact Emma Huther at ehuther@medicaldevices.org to join any of these and other MDMA Working Groups. If you are interested in learning more about MDMA membership, please contact Sheri at sdevinney@medicaldevices.org.

Additionally, below please find important resources available to companies that can assist your efforts to combat the virus.

Please click the button below for additional information.


 

Important COVID-19 Actions, Announcements & Updates:

 

click on the resource title below:

FDA Resources

Essential Employees/State Actions

Business Loans/Liquidity

Return to Work Resources

Congressional Activity

CMS Resources

Medical Supply Needs

Additional Resources

 

FDA Resources


FDA Recommendations: Protecting Medical Device Manufacturing Personnel During COVID-19


FDA Virtual Town Hall Series for Manufacturers on COVID-19 Diagnostic Tests


FDA Information on Emergency Use Authorization (EUA) & List of all Current EUAs


FDA COVID-19 Guidance Document Resource Page


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


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


PLEASE CLICK HERE FOR ADDITIONAL FDA RESOURCES


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Essential Employees / State Actions


Natl Assn of Mfgs (NAM) State-by-State COVID Operations Snapshot & State & Regional Resources


Natl Governors Assn (NGA) tracking of state-by-state shelter in place (SIP) orders


CDC Interim Guidance for Critical Infrastructure Workers Who May Have Had Exposure to COVID-19


CISA Advisory: Identification of Essential Critical Infrastructure Workers During COVID-19 Response - Additional Information


"Shelter in Place" Exemption Language supported by the Life Science Community


Sample Letter - Company Essential Employee Letter for Employees


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Business Loans / Liquidity


Main Street Lending Program (MSLP) Information & Term Sheets


June 8th MSLP Expansion Announcement


Additional MSLP Information & Documents


SBA Paycheck Protection Program (PPP) website & Dept. of Treasury PPP website & PPP FAQs


National Venture Capital Assn (NVCA) PPP Loan Program: Application & Affiliation Guidance


MDMA Letter to Treasury & Federal Reserve re: Updating MSLP Term Sheets to Provide the Greatest Access to the Program


MDMA Letter to Treasury & Federal Reserve re: An Effective & Efficient Main Street Business Lending Program


MDMA Letter to SBA & Dept of Treasury: Clarification of Small Business Eligibility under SBA 7(a) Loan Program


PLEASE CLICK HERE FOR ADDITIONAL BUSINESS

LOANS/LIQUIDITY RESOURCES


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"Return to Work" Resources


OSHA COVID-19 FAQ


FFCRA - Department of Labor Summary


FFCRA - Guidance Regarding Summer Programs


CDC: People of Any Age with Underlying Medical Conditions


EEOC: What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws


OSHA - Social Distancing at Work


OSHA - Guidance for Stockroom and Loading Dock Workers


OSHA - Revised Enforcement Guidance for Recording Cases of Coronavirus Disease 2019 (COVID-19)


NGA - State by State Workplace Reopening Guidance


MDMA, Broad Coalition Urge Congress on Liability Protections


CDC Activities and Initiatives Supporting the COVID-19 Response and the President's Plan for Opening America Up Again


CDC Reopening Workplace Decision Tree


Johns Hopkins Operational Toolkit


Opening Up American Again - The White House


FEMA Fact Sheet - Reconstituting Operations


CDC & OSHA - Manufacturing Workers and Employers Interim Guidance


FEMA Reconstituting Operations Workshop


FEMA Reconstituting Operations Sample Facilitator Guide


Alliant - Return to Work Playbook


HIPAA-Employers and Health Information in the Workplace


OSHA: Guidance for Preparing Workplaces for COVID-19


EPA: List N - Disinfectants for Use Against COVID-19


CDC: Interim Guidance for Businesses and Employers to Plan and Respond to Coronavirus Disease 2019


CDC: Implementing Safety Practices for Critical Infrastructure Workers


CDC: Cleaning and Disinfecting Your Facility


CDC: Business FAQs

 


FEMA Guidance: Addressing PPE Needs in Non-Healthcare Setting 


Joint Statement from AHA & Other Societies: Roadmap for Resuming Elective Surgery after COVID-19 Pandemic


Department of Labor OSHA Memo: Enforcement Guidance for Recording Cases of Coronavirus Disease 2019 (COVID-19)


Santa Clara County - Social-Distancing Protocol


MA High Technology Council - COVID-19-RTW Briefing


PLEASE CLICK HERE FOR SAMPLE POLICIES & PROCEDURES


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Congressional Activity


CARES ACT 3.5 small business summary & healthcare summary


CARES ACT / "Phase 3 Stimulus" (Legislative Text) + FACT SHEET


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


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


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


PLEASE CLICK HERE FOR ADDITIONAL CONGRESSIONAL ACTIVITY


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CMS Resources


Administration Encourages Reopening of Healthcare Facilities


Announcement: Second Round of Changes to Support U.S. Healthcare System During COVID-19 Pandemic


Recommendations for Re-opening Facilities to Provide NON-emergent Non-COVID-19 Healthcare: Phase I


CMS Reevaluates Accelerated Payment Program and Suspends Advance Payment Program


Non-Emergent, Elective Medical Services and Treatment Recommendations


CMS actions to help providers address patients' needs during the COVID-19 pandemic


CMS expansion of accelerated & advanced payment program to combat COVID-19


OPEN PAYMENTS PROGRAM – COVID-19 Announcement


CLICK HERE FOR ADDITIONAL CMS RESOURCES


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Medical Supplies Needs


Defense Department's Join Acquisition Task Force Portal to share ideas on how to combat COVID-19


FEMA Offers Ways for Private Sector to Help Fight COVID-19 + FEMA Platform: How to Help


FEMA Fact Sheet: Supply Chain Stabilization Task Force


To sell medical supplies or equipment to the federal government, please submit a price quote under the COVID-19 PPE and Medical Supplies Request for Quotation. Full details can be found in the solicitation (Notice ID 70FA2020R00000011). This solicitation requires registration with the System for Award Management (SAM) in order to be considered for award, pursuant to applicable regulations and guidelines. Registration information can be found at www.sam.gov. Registration must be "ACTIVE" at the time of award.


If you have medical supplies or equipment to donate, please provide us details on what you are offering


If you are a private company that wants to produce a product related to the COVID response - email nbeoc@max.gov


If you are a hospital and other companies in need of medical supplies, contact your State Department of Public Health and/or Emergency Management


For non-medical supplies, services or equipment, if you are interested in doing business with FEMA, visit our Industry Liaison Program


Paths for medical device companies to partner with the federal government


EO Delegating Additional Authority Under the DPA with Respect to Health and Medical Resources to Respond to the Spread of COVID-19


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Additional Resources


White House Resource Page


CDC Resource Page


Helpful Links & Resources from other Federal Agencies


NAM: COVID-19 Resources


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