The non-profit organization states that 60–70% of KN95 masks tested do not filter 95% of aerosol particulates.
Special controls are also provided for reasonable assurance of the safety and effectiveness of the devices impacted by the reclassification.
Designers and manufacturers of both devices and software must conduct due diligence and ensure regulatory compliance in protecting user data.
The agency recently released a guidance document that gives device manufacturers an optional pathway to make certain modifications to their device.
CooperVision, Inc. and Pentax of America won the agency approvals, respectively.
This new pathway is a considerable change for the medical device industry.
Manufacturers Mentor and Sientra did not adequately comply with post-approval study requirements that look at the long-term safety and risks of silicone implants.
The document aims to clear up how the agency looks at device functions that aren’t subject to premarket review of safety and effectiveness.
When device modifications could affect safety and effectiveness, a premarket notification submission is required.
Device companies need to think about how their product interacts with systems and users.