To increase the availability of Face Masks Intended for Medical Purpose, Surgical Face Masks and N95 Respirators, needed for the protection of health care professionals who are treating patients with Coronavirus (COVID-19) in USA, FDA is willing to expedite the review of unapproved devices under the Emergency Use Authorization (EUA) process.
FDA EUA APPLICATION CONTENT:
To check eligibility for FDA EUA, manufacturers (Foreign and domestic) of unapproved Face Masks Intended for a Medical Purpose, Surgical Face Masks and N95 Respirators can submit an application to FDA with 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)
- General information about the device such as the proprietary or brand name, model number, and marketing authorization in your country.
- A copy of the product labeling.
- A copy of the registration in foreign country is available.
- A copy of certificate for quality management system ISO:13485 or equivalent.
- Description of testing conducted on the device, including any standards met, such as liquid barrier protection, flammability, biocompatibility, and filtration performance, as appropriate.
- For surgical N95 respirators, FDA recommends including fluid resistance testing (liquid barrier performance).
To check your eligibility for EUA, please contact Global Regulatory Partners at email@example.com
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.