Regulations on N95 Respirators Reduced

The US Federal Drug Administration (FDA) has published a final order to exempt certain N95 face masks from pre-market notification requirements in order to reduce redundancies in process between itself and the National Institute for Occupational Safety and Health (NIOSH). The subset of N95 masks is used for healthcare purposes, such as protecting both patients and healthcare staff from microorganisms, body fluid, and airborne particles. They are disposable and meant for single-use only.

Currently, these masks are regulated by the FDA under product code MSH. In addition to streamlining process, this exemption will decrease the regulatory burden on respirator manufacturers as well as eliminate the private costs and expenses needed to comply with certain regulations.

NIOSH and FDA have entered into a Memorandum of Understanding (MOU) following the final order that will provide the framework for regulatory supervision. It also outlines both agencies’ review processes.

Updated Processes for N95

Starting on July 2, 2018, NIOSH will accept applications to implement these new processes for manufacturers intending to submit N95 respirator masks for use in healthcare. This new process will still be in accordance with OSHA’s respiratory protection standard requirements.

Here’s how the new process will work:

• Manufacturers will only be required to submit one application to NIOSH rather than both NIOSH and the FDA.
• NIOSH will continue to be responsible for ensuring these devices provide expected performance levels and are safe to use.
• NIOSH, instead of the FDA, will now be responsible for evaluating the manufacturer’s test data for conformity to standards of flammability, biocompatibility, and fluid resistance.

Respirator Fit Testing

Employers will still be responsible for conducting respirator fit testing. If your workers regularly use respiratory protection, contact Worksite Medical to make sure you’re in compliance with OSHA standards. Our mobile medical units and staff can come directly to your workplace and perform respirator fit tests. It’s also important that employees do a quick seal check anytime they wear a respirator.  

Did you know that any employee required to wear a respirator at work must complete a medical clearance questionnaire? At Worksite Medical, we make completing the form easy and affordable. Your employees can complete the questionnaire online, have it reviewed by our staff PLHCP Medical Provider, and have a respirator clearance certificate issued within five business days. Learn more online or give Worksite Medical a call at 1-844-OCCUMED.