CDRH helps reduce makers' product regulation, classification frustration at Device Advice site - Center for Devices and Radiological Health web site - Brief Article

Health Industry Today, May, 2001

Manufacturers frustrated with trying to work their way through the maze of U.S. Food and Drug Administration (FDA) regulations and device classification processes should take heart from a self-service Web site posted by the Center for Devices and Radiological Health (CDRH).

The agency said the purpose of the Internet location, called Device Advice, is to "provide a mechanism for manufacturers and other interested persons to become acquainted with the process of obtaining FDA clearance to market a medical device and meet the FDA requirements for radiation-emitting products."

CDRH says the process is expedited by working through sequential steps necessary to determine:

* Whether the product seeking marketing clearance is a radiation-emitting product, a medical device, both a radiation-emitting produce and a medical device, or neither a radiation-emitting product nor a medical device

* The FDA reporting requirements and standards that may apply for an electronic radiation-emitting product

* The classification of the product if it is a medical device

* The process for obtaining the appropriate clearance to market the medical device based upon the classification of the medical device

* Information on any other requirements that may apply to a product.

FDA has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels.

Each of the generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device (Class I - III).

The class to which a device is assigned determines, among other things, the type of premarket submission/application required for FDA clearance to market the device.

Device Advice helps determine classification by utilizing a click-through process.

To find the classification of a device, as well as any exemptions that may exist, users go to the classification database and search via a part of the device name, or use a device panel to identify the device and corresponding regulation.

FDA says Device Advice is set up with pages that describe additional procedures and link to appropriate documents on the CDRH Homepage.

Sites that contain guidance documents, databases and manuals that help meet marketing requirements, as well as answer questions, are accessible with the click of a mouse.

Access the site at www.fda.gov/cdrh/devadvice.>

COPYRIGHT 2001 J.B. Lippincott Company

COPYRIGHT 2001 Gale Group