Developing medical devices in general is costly, but there is funding available for companies that are willing to create products specifically for pediatrics.
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.
Infusion pump companies are perpetuating misconceptions.
The center will start phasing in efficiencies on March 18.
The resignation will be effective in about a month, according to reports.
The regulation is bringing digital enablement to the forefront, requiring electronic instructions for use.
According to the FDA, more than 90% of products sterilized at the facility are medical devices.
Learn about the new subclass for Class I reusable devices under MDR and the necessary steps to ensure compliance.
The new pump allows patients to customize their diabetes management.
If you’re looking to market your medical device, there are many tasks to complete.