PPB August 2020

assessment, deployment, training, disinfection and disposal. • Any marketing claims fall to the co-jurisdiction of the FDA and Federal Trade Commission (FTC). For manufacturers and importers of masks intended to be distributed within this category: • Register the production site. A Good Manufacturing Practices (cGMP) audit is required for completing the registration process with the FDA. • Register the product. The mask, specifications, testing and packaging are submitted for review to the FDA (masks registered as PPE compliant to ANSI Z88 standards must also be submitted to NIOSH for certification). Standards include non-irritating body contact fabrication, compliance with Class I or Class II flammability per 16 CFR 1610 (unless labeled against use in environments with potential exposure to high-intensity heat {e.g. laser} or flammable gas {e.g. oxygen}) and fluid resistance barriers, all to be validated through testing. º Manufacture lot coding and expiration dates are required. • For single-use, disposable masks, exterior packaging and inner packaging of units must contain a printed description that includes the product name and a description of the product, the manufacturer name and location, the production lot code and an expiration date. • For single-use N95 masks and respirators, a printed description on the mask that includes the product name and model number, the manufacturer’s name and location, the production code and expiration date is required. Additionally, NIOSH-registered masks require mask exterior markings including “NIOSH” in block letters, the Testing and Certificate (TC) approval number and a warning describing the cautions and limitations of usage. (NOTE: Any decoration on or modification to a NIOSH-approved model invalidates the TC approval.) • Retain all relevant development, validation and production records for masks produced under the EUA until otherwise notified by the FDA. The FDA may, at any time, request inspection of all applicable records. º For importers: • Advise manufacturers of the above guidelines. • Ensure all masks are correctly classified for importation. Anzhela Shvab / Shutterstock.com 80 | AUGUST 2020 | THINK