by Jim Macdonell

USDM offers support to companies that are focused on PPE, diagnostic tests, medical devices, and the need to increase the supply of these devices to those in need.

The life sciences industry has been mobilized to deliver personal protective equipment (PPE), diagnostics, therapeutics, and vaccines to fight COVID-19, while hundreds of companies and academic institutions are fast-tracking their vaccine and treatment efforts. 
The U.S. Food and Drug Administration (FDA) is providing extensive guidance and direction, including Emergency Use Authorization (EUA) to address the COVID-19 pandemic. COVID-19 EUAs can be found on the FDA website. You can also find the enforcement policy for gowns, other apparel, and gloves on the site. 

USDM is committed to sharing our knowledge to clarify terms and requirements as you continue in these important initiatives. There are three segments in particular where USDM can provide guidance as the regulations evolve. 

  1. Existing medical device companies with devices approved for sale IN THE UNITED STATES. USDM can provide additional capacity to help you increase production, get approvals, and release your devices or tests for new uses. We have vast experience with the technology and compliance you need to expand capacity, particularly if you need to extend your technology and compliance governance to new partners to supplement your production capabilities. 

  1. Existing medical device companies with devices approved for sale OUTSIDE THE UNITED STATES. Diagnostic, treatment, and protective devices approved by other regulatory agencies offer attractive alternatives to fill the various needs in the United States. FDA guidance is specific to the device. The process, substantiated device design, testing, and technical documentation are critical to receiving the authorization required to ship your medical devices to the United States.  

  1. Companies entering the medical device industry. You can appeal directly to the FDA and initiate a process under EUA to be approved to sell medical devices. Additionally, companies partnered with an existing medical device company can be approved. In both cases, USDM can: 

    • Clarify, educate, and interpret the regulatory process 
    • Support the execution of your regulated processes 
    • Rapidly implement compliant technology solutions to speed up and optimize your process 
    • ​Provide supplemental regulatory, quality, and IT staffing or consulting resources 

As experts in regulated processes and technology, USDM can help you rapidly implement, validate, or optimize your regulatory processes to get your products to market faster. Contact us if you need technology solutions, compliance services, or staffing support as you continue to respond to COVID-19. 

Regulatory Compliance Services to Fast-Track Business Continuity

About the Author
Jim Macdonell is the Vice President of Medical Device Solutions at USDM Life Sciences. Jim is responsible for driving solutions for our medical device customers and staying at the forefront of regulatory and technology challenges facing the medical device industry. Jim is a seasoned consulting leader with more than 25 years of experience defining customer strategies and building and managing implementation teams.

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