Manufacturers of the surgical mesh devices have not provided reasonable assurances of safety and effectiveness, according to the agency.
Strong evidence of proper cleaning and reprocessing that eliminates the spread of bacterial infections is still not there, and improvements are necessary, says Shuren.
This new pathway is a considerable change for the medical device industry.
Viant Medical’s Grand Rapids, MI facility was hit with violations from the Michigan Department of Environmental Quality.
Improving healthcare cost, quality and outcomes through analytics: Perspectives from key stakeholders.
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 center will start phasing in efficiencies on March 18.
According to the FDA, more than 90% of products sterilized at the facility are medical devices.
The new pump allows patients to customize their diabetes management.
The agency’s intent is to decrease regulatory burden while promoting patient access to products.