The agency’s latest announcements are indicative of its focus on risk reduction while promoting innovation.
The agency will be improving postmarket surveillance, looking at issues that come up once a device is on the market, and promoting innovation.
When adulterated products are manufactured in a foreign establishment, don’t expect FDA to admit them into the country.
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.
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.
It is one of the most basic of quality requirements.
The agency anticipates the program will result in a two-thirds reduction of the amount of device malfunction reports submitted by manufacturers.
Procedures for design validation must address risk analysis where appropriate.