Who is the FDA?

(from Wikipedia, the free encyclopedia – redirected from www.fda.gov)

The U.S. Food and Drug Administration (FDA) is an agency within the United States Department of Health and Human Services and is responsible for the safety regulation of most types of food, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products and cosmetics.

The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on products ranging from pet turtles to semen donations for assisted reproductive medicine techniques.

The FDA was formed in 1906¹. Preceding Agencies were the Division of Chemistry, USDA, (established 1862); Bureau of Chemistry, USDA (July 1901 through July 1927); and the Food, Drug and Insecticide Administration (July 1927 to July 1930).

It is responsible for protecting and promoting the nation’s public health. The FDA is headquartered in Rockville, MD with 223 field offices² supported by 13 laboratories located throughout the United States, the U.S. Virgin Islands, and Puerto Rico.

FDA Facts You Need To Know

For information, all invasive devices related to the human body must be registered with the United Stated Food & Drug Administration (FDA). This is the case of most medical and dental instruments and equipment – even medicines and supplies.

It is a violation to market any such device without a Premarket Notification Approval.

All Foreign (not American) device manufacturers MUST register their establishment with the FDA. (See pricing below)

If the FDA district office determines that the device, manufacturer, or importer has not complied with FDA import requirements, the device will be detained at the port of entry and the importer will be given a “Notice of Detention and Hearing.” At this point, the importer, the foreign manufacturer, or the device itself must be brought into compliance before the device is released.

Who needs to submit a FDA 510k Premarket Notification?

Medical device manufacturers are required to register a 510k Premarket Notification with the U.S. Food & Drug Administration to show their intent to market a medical device at least 90days in advance. This allows them (FDA) to determine whether your device is generally equivalent to similar ones already on the market.

Who must submit a 510k Premarket Notification application?

Manufacturers and/or importers of some Class 1 and 3, and most Class 2 medical devices are required to file a 510k, including:

• medical device manufacturers or importers and exporters that wish to introduce a new medical device to the US market if a ‘Predicated’ device already exists.
• Specification developers that design a device and have it manufactured by another company for eventual sale in the US
• Companies that are proposing a significantly different design or different ‘Intended Use’ for a product that is already sold in the US
• Relabelers or repackagers of devices

Who does not need to submit a 510k Premarket Notification?

You do not need to file a 510k application with the FDA if:
• you manufacture or import a Class 1 medical device that does not fall into the ‘reserved’ category
• you manufacture a component, unless the component is also sold as a replacement part, or is a software product working together with devices..

The FDA charges fees to review and approve your 510k application.

Application Fee – Payable to the FDA:


2010 - $4,007 ($2,004*)
2011 - $4,348 ($2,174*)
2012 - $4,717 ($2,359*)

* for small businesses (Denterprise has that status).

Establishment Registration Fee – Payable to the FDA every year by every registered medical device company:


2010 - $2,008
2011 - $2,179
2012 - $2,364

References:
¹ taken from: http://www.fda.gov/centennial/
² taken from: http://www.fda.gov/oc/oms/ofm/budget/2009/Narratives/8_ORA.pdf
³ taken from: http://www.fda.gov/cdrh/manual/ireas.html#20