NIOSH / FDA MOU
Summary
MOU는 FDA 와 NOISH 간의 Surgical N95 FFRs 에 관한 내용 임.
- MOU Number : MOU 225-18-006 (=> Here)
- PDF Document : MOU 225-18-006 _ FDA.pdf
** FFR : Filtering Facepiece Respirator
N95 respirators that are both certified by NIOSH and cleared by the FDA as medical devices for use by healthcare personnel are called “surgical N95 respirators.”
– Source : CDC Web Site
What is a surgical N95 respirator? => LINK
A surgical N95 respirator is a NIOSH-approved N95 respirator that has also been cleared by the Food and Drug Administration (FDA) as a surgical mask. These products are noted in bold font on the table of NIOSH-approved N95 respirators. For your convenience, view a comprehensive table of these products. If you have a product that you believe is FDA cleared that does not appear on this table, you should verify the FDA clearance by contacting the FDA at 1-800-638-2041.
The National Institute for Occupational Safety and Health (NIOSH) is the U.S. Government agency responsible for the certification and approval of respiratory protective devices for occupational use. The authority is granted to NIOSH in accordance with conditions and standards established in Title 42 of the Code of Federal Regulations (CFR), Part 84. It also addresses quality assurance requirements for the manufacturing of respiratory protective equipment. The approach to approval is that anybody can manufacture and sell any type of respiratory protective device, but only those that meet or exceed all of the requirements established in the 42 CFR Part 84 standards are acknowledged by NIOSH, and only those that have been NIOSH certified may be marketed as a NIOSH-approved respirator.
The FDA is the U.S. Government agency that oversees most medical products, foods, and cosmetics. Within the FDA, the Center for Devices and Radiological Health (CDRH) oversees the safety and effectiveness of medical devices. Medical devices intended for use in preventing and treating disease is subject to regulation under the device provisions of the Federal Food, Drug, and Cosmetic Act. This includes surgical masks and surgical N95 respirators. The FDA has no role in the approval or clearance of N95 respirators not intended for use as a medical device.
View a table of Surgical N95s which is provided as a courtesy. If you have a product that you believe is FDA cleared that does not appear on this table, you should verify the FDA clearance by contacting the FDA at 1-800-638-2041.
