What is secsec 513?
What is secsec 513?
Sec. 513. Unrelated Trade Or Business Connecting decision makers to a dynamic network of information, people and ideas, Bloomberg quickly and accurately delivers business and financial information, news and insight around the world.
Why is section 513(G) important to device manufacturers?
As such, understanding how to use the mechanism is important to device manufacturers. What is Section 513 (g)? Section 513 (g) of the Federal Food, Drug, and Cosmetic Act provides a means for device manufacturers to obtain information about the Food and Drug Administration’s views regarding the classification of a device.
What is the 513(G) mechanism?
The 513 (g) mechanism serves as a useful resource for device manufacturers determining the best course of action for development of devices.
How do I submit a 513(G) application?
Medical device companies should submit a 513 (g) application in writing to the appropriate office and identify it as such. The application should contain a cover letter, a description of the device, a description of the indicated use of the device, any proposed labeling and marketing materials for the device.
