The FDA said today it wants to hear from surgical mask and gown manufacturers that might be able to increase or speed production to prevent shortages in the U.S. during the COVID-19 outbreak.
The agency said it may expedite review of manufacturing site changes or premarket submissions of personal protective equipment, including protective clothing, gowns, gloves, face shields, goggles, face masks and respirators, or other equipment designed to protect the wearer from injury or the spread of infection or illness.
The agency urged these manufacturers to email the FDA at firstname.lastname@example.org using this subject line: “Product Codes XXX, Shortage Mitigation Options for FDA Engagement,” where XXX represents the following product code(s):
- Surgical masks (FXX).
- Surgical mask with antimicrobial/antiviral agent (OUK).
- Pediatric/child facemask (OXZ).
- Surgical gowns (FYA).
- Isolation gowns and surgical apparel accessories (FYC, LYU, OEA).
- Surgical suits (FXO).
The body of the email should describe the affected product or products with the brand name, model number, 510(k) number, etc., and also describe the how the manufacturer propose to mitigate a shortage. Those subjects may include:
- Expedited review of a premarket submission.
- Expedited review of a manufacturing site change if you are a class III device manufacturer,
- Information about importing certain products.
The FDA said that the mailbox is closely monitored and has proven to be a valuable resource thus far in helping it mitigate potential supply chain disruptions.
“The FDA’s door is open, and we are available to collaborate with stakeholders,” the agency said.
More information on how manufacturers can prevent shortages can be found here.
FAQs on shortages of these products may be found here.