Report: FDA exempts surgical facemasks from 510(k) requirements

The FDA finalized a rule this week exempting specific disposable respiratory protective masks from 510(k) requirements, according to a Regulatory Affairs Professionals Society report.

The move was adopted in hopes of reducing regulatory burden on manufacturers of the surgical apparel devices and to eliminate the costs associated with regulatory clearance, according to the report.

With the order, which was proposed last December, N95 filtering face piece respirators and surgical N95 respirators will be exempt from 510(k) review, with certain limitations, RAPS reports.

The exemption will only apply to the two single-use respiratory devices, while all other devices under the surgical apparel classification regulation will continue to be subject to review, according to the report.

Yesterday, the FDA approved the first non-opioid treatment designed to help manage the symptoms of opioid withdrawal in adults.

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