Manufacturing Personal Protective Equipment (PPE) on Long Island?
To help ensure medical devices, including PPE are safe and effective, the FDA has established Quality Systems Regulations and Good Manufacturing Practices. Manufacturers are expected to use these regulations and practices to maintain consistent product quality and to guide performance testing to make sure that their products conform to recognized consensus standards. For PPE, these standards may include for fluid resistance, leak protection, filtering capacity, or resistance to tears and snags. When these regulations and practices are followed, they provide reasonable assurance that the device is safe and effective. They can be found on the FDA Website.
o Any business with supplies to sell/contribute to New York’s response can contact the Governor’s team at [email protected].
o For up to date information, please see https://esd.ny.gov/.
o If you want to donate medical supplies or equipment to the federal response, please go to www.fema.gov and use the online medical supplies and equipment form at www.fema.gov/coronavirus/covid-19-donations
o If you want to sell medical supplies or equipment to the federal government, please email specifics to [email protected].
o The FDA established a special email inbox, [email protected], for industry representatives to quickly communicate with the agency and address questions or concerns.
