The FDA recognizes that the need by healthcare providers and personnel for personal protective equipment (PPE) such as surgical masks and surgical and isolation gowns, may outpace the supply during the Coronavirus Disease 2019 (COVID-19) outbreak.
The FDA is collaborating with manufacturers of personal protective equipment (PPE) to help facilitate mitigation strategies related to the COVID-19 outbreak. The FDA’s door is open, and we are available to collaborate with stakeholders.
To help alleviate supply pressures, the FDA may consider expedited review of manufacturing site changes or premarket submissions—manufacturers of PPE (particularly surgical masks and surgical or isolation gowns) may contact FDA regarding plans to increase availability of these products to the U.S. market.
For reference, the applicable product codes discussed in these FAQs are:
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)
FDA is interested in hearing from manufacturers who may be able to help mitigate potential shortages of the above product codes by increasing U.S. availability of such devices. These manufacturers may email FDA at firstname.lastname@example.org, which is closely monitored and has proven to be a valuable resource thus far in helping FDA mitigate potential supply chain disruptions.
To facilitate a rapid response to your email, please see an example of information that FDA would find helpful to have initially below:
Subject of the email: “Product Codes XXX, Shortage Mitigation Options for FDA Engagement,” where XXX represents the product code(s).
Body of the email:
Describe the affected product or products which may include the brand name, model number, 510(k) number, etc.
Describe the proposed mitigation approach.
Identify what you are interested in discussing with FDA, such as:
Expedited review of a premarket submission, or
Expedited review of a manufacturing site change if you are a class III device manufacturer, or
Information about importing certain products.