To face the increase demand of ventilators and other respiratory devices in USA due to the COVID-19 pandemic, US FDA released a new guidance (FDA Ventilators-Enforcement-Guidance) on the expedited review of new ventilator under the Emergency Use Authorization (EUA) program.
FDA believes that most companies may already have available information to help support an EUA request for ventilators, such as the information outlined below. FDA will expeditiously review this information, and other required information, to determine if an EUA can be issued.
Current Requirements For Manufactors with no Prior FDA Approval
For current ventilator manufacturers whose product(s) are not currently marketed in the US, FDA recommends providing the following information:
- General information such as your contact information, name and place of business, email address, and contact information for a U.S. agent (if any), in addition to general information about the device such as the proprietary or brand name, model number, and marketing authorization in your country (or region).
- A copy of the product labeling.
- Whether the device currently has marketing authorization in another regulatory jurisdiction such as the European CE Mark, Australian Register of Therapeutic Goods (ARTG) Certificate of Inclusion, Health Canada License, or Japan Pharmaceuticals and Medical Device (PMDA) approval.
- Whether the device has been designed, evaluated, and validated in accordance with the applicable FDA recognized standards.
- Whether the device is manufactured in compliance with 21 CFR Part 820 or ISO 13485, or an equivalent quality system.
- Whether the device is designed with a power supply that is compatible with United States voltage, frequency, and plug type standards.
FDA Acknowledged Receipt:
After receiving the information above, FDA will acknowledge its receipt will work interactively with those manufacturers to facilitate the distribution of their products through an Emergency Use Authorization in the United States. Manufacturers who are unable to provide all the above information are still eligible for EUA consideration and should engage with FDA through the pre-EUA process.
FDA EUA product development email:
Requests for product development for proposed COVID-19 uses and drug development should be sent to email@example.com
Global Regulatory Partners is Supporting the Fight Against Coronavirus (COVID-19) Contact us to learn more.
About Global Regulatory Partners:
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.
More Like this: