Lift FDA Restrictions on Life-saving PPE, Tests, and Ventilators!

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Claudia Truesdell
Claudia Truesdell signed this petition

American doctors and nurses desperately need more personal protective equipment (PPE), diagnostic tests and ventilators to keep us all safe from the novel coronavirus (SARS-CoV-2). In addition first responders, key government employees and those who work in essential services like grocery, pharmacy, utilities and logistics need PPE so that they can continue working in a way that is safe for all of us. But unnecessary red tape is keeping all of them from getting these critical supplies. This is putting everyone’s lives at risk.

The problem: the US only allows FDA-certified PPE, diagnostic tests and ventilators to be imported and used with a stated policy and enforcement system of “FDA does not recognize regulatory authorizations from other countries.” ref: https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/importing-medical-devices-and-radiation-emitting-electronic-products-us . We could immediately access a lot more equipment if we relaxed changed this so that at least temporarily during a crisis, or more generally whenever supply of FDA-certified equipment is even slightly low. See here for a more detailed explaination of how if you want to import equipment that has ALREADY BEEN CERTIFIED by another country's equilaent to the FDA you must jump through a mountain of red tape at the risk of being rejected at several points and/or paying fees: https://drive.google.com/file/d/136RYWcedVhlvFF7-pondi6HygpE7WcSR/view?usp=sharing

The US federal government should allow for PPE, diagnostic tests and ventilators that have been certified by other reputable bodies besides the FDA to be EASILY imported and used. This could include AT A MINIMUM all members of the International Medical Device Regulators Forum: http://www.imdrf.org/about/about.asp#mcm plus Mexico, COFEPRIS.

As an example, just one supplier in China I found (via onsite inspection by relatives in China) has the following supplies available for immediate purchase:

  • 500,000 surgical masks
  • 100,000 N95 masks
  • 500,000 COVID-19 rapid test kits

These products are currently available today in inventory—but no one in the US can import them, as they only have EU’s CE certification and are not FDA-approved! There are thousands of potential suppliers like this with stock and production capacity today that could be tapped to eliminate the supply shortage that has been costing, and will continue to cost, an increasing number of lives in the US.

We can solve this particular issue and increase the efficiency of the global supply chain quickly in 2 ways:

  1. We get the FDA/CBP to issue the blanket approval for internationally certified equipment for the duration of this pandemic.
  2. We get a clause inserted into one of the next COVID-19 inspired bills to be passed by the house and senate to effect the same.

In addition to signing this petition and sharing it within your personal/professional networks, please also consider directly reaching out to your elected officials at every level to push for opening the supply chain as proposed: https://www.commoncause.org/find-your-representative/change-your-address/