FDA

FDA

FDA

Introduction

Americans are avid consumers, as well as the Federal Food, medicines, cosmetics, and the law (FDCA) (52 Stat. 1040), covers the products, which make up almost a quarter of every dollar spent. In the FDCA and the agency that implements it, food and medicines (FDA), to manage safety and accurate labeling of a trillion dollars of products annually, including recipes, and most medicines, cosmetics, medical devices, blood and tissue products and the nation's total food except for meat and poultry.

Discussion

Section 510 (K) [11] Federal Food, medicines, cosmetics and the Act requires those device manufacturers who must register to notify FDA at least 90 days in advance, of its intention to market medical devices. (Medical Device Safety and Sterility, 2006,)

This is called a Premarket Notification - also called PMN or 510 (K). It allows the FDA to determine whether a device is equivalent to a device already placed into one of three categories of classification.

Any device, which comes to the market through 510 (K), the notice must be "substantially equivalent" devices on the market before 28 May 1976 (the "main block"). If the device, it is significantly different, compared to 1976 for the device, in terms of design, materials, chemistry, energy, processing or use, the device should be nominally the prior approval of the market, or PMA. Since 2007, this will be done by separating the devices into three categories: (Medical Device Safety and Sterility, 2006,)

Class I: Devices that do not require premarket approval or clearance, but must conform to common control. Dental floss is the sort of device.

Class II devices that are removed with the help of 510 (k) processes. Diagnostic tests, cardiac catheters and amalgam alloys used to fill the cavities of class II.

Class III: a device that had been approved Premarket Approval (PMA), and ...