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.
Validation is an obstacle to implementing technology. A streamlined approach is necessary.
CDRH is urging the development of medical technologies and diagnostic tests that address pain, addiction and diversion.
When FDA says stop, they mean stop!