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FDA Guidelines and Standards


The FDA is an agency within the Department of Health and Human Services and consists of nine centers and offices.

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.

The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

FDA Regulatory Overview
Further information about the regulatory power of the FDA can be found at these links:

The Food and Drugs Act of 1906 and other congressional milestones are presented in this section.

Rules & Regulations
Rules and regulations help FDA ensure that regulated products are safe and effective.

Guidances represent FDA's current thinking on a topic. They do not create/confer rights or bind FDA or the public.

Dockets Management
Dockets management serves as the official repository for the administrative proceedings and rule-making documents for FDA.

(Source: FDA)

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About the Center for Devices and Radiological Health

FDA's Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions. It is under this center that dental devices are regulated. Examples of regulated dental devices inlcude dental handpieces, dental chairs and accessories, and dental curing lights.

Dental Amalgam is also another product regulated by the FDA.

Dental Radiography: Doses and Film Speed

The FDA is encouraging dental professionals to make a simple and economic switch to "faster" X-ray film to further reduce your radiation exposure. This article explains how they can do it.

ADA / FDA Guide to Patient Selection for Dental Radiographs

The Office of Communication, Education, and Radiation Programs (OCER) in conjunction with the American Dental Association has updated the 1987 FDA publication The Selection of Patients for X-Ray Examinations: Dental Radiographic Examinations. The recommendations in this updated document provide the dentist with a strategy for ordering x-ray examinations for patients seeking treatment while at the same time minimizing radiation exposure. 

The FDA also regulates dental radiography devices.
(Source: FDA)

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New Guidance                    

On March 12, 2015, the FDA published a final guidance on reprocessing reusable medical devices. This guidance is a step toward further reducing the risk of patient infection by providing manufacturers with recommendations to validate their reprocessing instructions to ensure devices remain safe and effective for reuse.

Access SLIDES from March 24, 2015 webinar.

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