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Applying to the FDA...

The Class II group is by far the greatest number of FDA applications. Most diagnostic and interventional / treatment devices fall into this class. The law that the U.S. Congress passed requires that to receive a "clearance to market" a Class II device, the device must be must be determined "substantially equivalent" to a pre-amendment device (in commerce before 1976) or determined "substantially equivalent" to a device submitted to the FDA per paragraph 510(K) of the Code of Federal Regulations (21CFR). That process is now regarded as a 510(K). The FDA has over the years grown certain interpretations that have expanded the law passed by Congress.

As a manufacturer or distributor you must "submit" a pre-market notification declaring your intentions to market the device.

The 510(K) process is designed for prototypes. The FDA almost forces submitters to "manufacturer" the product before the application is filed, however the law clearly applies to prototypes.

You must certify to the FDA that the device is safe and effective and was developed using design controls. You must submit all labeling and marketing claims. You must establish the device is substantially equivalent to a predicate device and sign certain declarations. You must demonstrate that the device will comply with Quality Systems. You must provide a safety analysis and support in the field. You must establish to the satisfaction of the FDA that the user receives the advertised performance of the product throughout the life of the product.

Devices are divided into either prescription or non-prescription devices. This often is designated by the FDA classifications, if not -the manufacturer declares the device to either be prescription or non-prescription.

At the occasion of the act the U.S. Congress was going to have the FDA issue performance standards for various categories of Class II devices. These performance standards were virtually never written.

Of the hundreds of Class II devices only several have a performance standard. Where a performance standard does not exist the primary controlling standard would be a control from a standards body such as: ANSI, ISO, AAMI, UL, EU or ISO.

The content and format of a 510(K) varies based on the risk and controls described by guidance documents issued for that classification of the medical device.

copyright by Compliance Consultants, Stamford, CT USA, September 2001