The draft provides suggestions on device design, labeling and documentation that should be included in premarket submissions.
The device is indicated for patients who have advanced heart failure and are not eligible for a transplant.
There have been reports of Type llla and lllb endoleaks related to the company’s AFX Endovascular AAA Systems.
Does your company understand the magnitude of the compliance effort?
Hackers and their ability to access systems remotely and disrupt healthcare organizations are a key concern.
The product can conduct electrocardiograms and measure the heart’s rhythms.
Innovators will also receive guidance in the areas of prototyping, engineering, IP, testing, grant-writing and clinical trial design.
The agency is aiming to provide more transparency and consistency in this area.
The Wall Street Journal reports that the scandal-ridden company will dissolve after failing to sell itself, and investors will lose nearly $1 billion.
Following protocols and maintaining compliance have been common themes.