FDA Considers Expedited Reviews to Alleviate Coronavirus Impact on Trials

Courtesy of Centers for Disease Control and Prevention. Credit: Hannah A Bullock; Azaibi Tamin

The U.S. Food and Drug Administration (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,” the agency said yesterday (March 11).

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,” it said.

For reference, the applicable product codes 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)

The 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 e-mail the FDA at deviceshortages@fda.hhs.gov, which is closely monitored and has proven to be a valuable resource thus far in helping the FDA mitigate potential supply chain disruptions.

To facilitate a rapid response to your e-mail, please see an example of information that the FDA would find helpful to have initially below:

Subject of the e-mail: “Product Codes XXX, Shortage Mitigation Options for FDA Engagement,” where XXX represents the product code(s).

Body of the e-mail:

  • 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 the 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.

Author: Michael Causey