The exemption reduces the regulatory burden on the medical device industry—including the time and costs involved in preparing, submitting and responding to requests for additional information.
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.
The agency’s intent is to decrease regulatory burden while promoting patient access to products.
When adulterated products are manufactured in a foreign establishment, don’t expect FDA to admit them into the country.
The agency states this list of more than 1000 devices doesn’t have risks that warrant premarket notification.