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FDA announces modifications to list of recognized standards

Device Regulation Alert: Safety, Compliance and Reimbursement News, January 14, 2008

In a December 19 Federal Register notice, the FDA published modifications to the list of FDA recognized standards for premarket reviews.

The FDA is authorized under federal law to recognize consensus standards to be used in demonstrating the safety and effectiveness of devices in premarket submissions. Those standards are available on the FDA Web site.

The December 19 notice lists modifications to the list of standards including additions, withdrawals, or changes to standards in the list. Nearly 30 standards were withdrawn and replaced with newer versions. Twenty new items were added to the list of recognized standards in the areas of:

• Anesthesia
• Dental/ENT
• General hospital/plastic surgery
• Ophthalmic
• Radiology
• Sterility

The list of recognized standards is accessible in the FDA's searchable database.

Finally, the FDA welcomed recommendations for consensus standards and described the information to be supplied with such recommendations including:

• Reasons supporting recommendation
• Name and address of the organization developing the standard
• Proposed list of devices to which the standard should apply
• Description of device characteristics that would be addressed by conformity with the standard

Click here to view the notice in the December 19 Federal Register.

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