Center for Devices and Radiological Health
Encyclopedia
The Center for Devices and Radiological Health (CDRH) is the branch of the United States
Food and Drug Administration
(FDA) responsible for the premarket approval of all medical device
s, as well as overseeing the manufacturing
, performance and safety of these devices. The CDRH also oversees the radiation safety performance of non-medical devices which emit certain types of electromagnetic radiation
, such as cellular phones and microwave ovens.
The current head of the CDRH is Jeffrey Shuren
, who took over in January 2010.
Class 1 devices include everyday items such as toothbrushes which are unlikely to cause serious consequences if they fail. Manufacturers are required to follow what are called "general controls" which closely match ISO 9000 requirements.
In addition to the general controls, Class 2 devices require an approval that is referred to as a "510(k)" after the relevant section of the Food, Drug and Cosmetic Act. The intent of this class was for new manufacturers of devices that already existed when the rules were established. A class 2 device is required to be "substantially equivalent" to existing devices. The class is now used for "medium risk" devices such as demineralized bone powder used for reconstructive surgery, which is officially substantially equivalent to Plaster of Paris, a much older product that was used for the same purpose. This equivalence is used when the FDA does not think a full approval process with extensive clinical trials is necessary.
The 510(k) approval process came under fire in February 2011 after the release of a study by Dr. Diana Zuckerman
and Paul Brown of the National Research Center for Women and Families
, and Dr. Steven Nissen of the Cleveland Clinic
, published in the Archives of Internal Medicine. It showed that most medical devices recalled in the last five years for “serious health problems or death” had been previously approved by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the 113 devices recalled, 35 were for cardiovacular issues. This may lead to a reevaluation of FDA procedures and better oversight.
Class 3 devices require a "Pre-market Approval" (PMA), which is analogous to the drug approval process with clinical trials and extensive review of the design. Class 3 devices tend to be products such as pacemakers which would cause obvious risk of injury or death if they did not function properly. As with all devices, the manufacturers must follow the general controls.
, and medical devices, Commissioner Arthur Hayes reorganized the FDA. This reorganization merged the bureaus responsible for medical devices and radiation control into their present form, the Center for Devices and Radiological Health
.
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) responsible for the premarket approval of all medical device
Medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
s, as well as overseeing the manufacturing
Manufacturing
Manufacturing is the use of machines, tools and labor to produce goods for use or sale. The term may refer to a range of human activity, from handicraft to high tech, but is most commonly applied to industrial production, in which raw materials are transformed into finished goods on a large scale...
, performance and safety of these devices. The CDRH also oversees the radiation safety performance of non-medical devices which emit certain types of electromagnetic radiation
Electromagnetic radiation
Electromagnetic radiation is a form of energy that exhibits wave-like behavior as it travels through space...
, such as cellular phones and microwave ovens.
The current head of the CDRH is Jeffrey Shuren
Jeffrey Shuren
-References:...
, who took over in January 2010.
Regulatory classes
CDRH splits medical devices into three classes with different regulatory requirements:Class 1 devices include everyday items such as toothbrushes which are unlikely to cause serious consequences if they fail. Manufacturers are required to follow what are called "general controls" which closely match ISO 9000 requirements.
In addition to the general controls, Class 2 devices require an approval that is referred to as a "510(k)" after the relevant section of the Food, Drug and Cosmetic Act. The intent of this class was for new manufacturers of devices that already existed when the rules were established. A class 2 device is required to be "substantially equivalent" to existing devices. The class is now used for "medium risk" devices such as demineralized bone powder used for reconstructive surgery, which is officially substantially equivalent to Plaster of Paris, a much older product that was used for the same purpose. This equivalence is used when the FDA does not think a full approval process with extensive clinical trials is necessary.
The 510(k) approval process came under fire in February 2011 after the release of a study by Dr. Diana Zuckerman
Diana Zuckerman
Diana M. Zuckerman is an expert on national health policy, particularly in women's health. She is the President of the National Research Center for Women & Families as well as the Cancer Prevention and Treatment Fund.-Life and work:...
and Paul Brown of the National Research Center for Women and Families
National Research Center for Women and Families
The National Research Center for Women & Families is a Washington, DC-based non-profit organization founded in 1999. It uses objective, research-based information to encourage new, more effective programs and policies that promote the health and safety of women, children, and families. The...
, and Dr. Steven Nissen of the Cleveland Clinic
Cleveland Clinic
The Cleveland Clinic is a multispecialty academic medical center located in Cleveland, Ohio, United States. The Cleveland Clinic is currently regarded as one of the top 4 hospitals in the United States as rated by U.S. News & World Report...
, published in the Archives of Internal Medicine. It showed that most medical devices recalled in the last five years for “serious health problems or death” had been previously approved by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the 113 devices recalled, 35 were for cardiovacular issues. This may lead to a reevaluation of FDA procedures and better oversight.
Class 3 devices require a "Pre-market Approval" (PMA), which is analogous to the drug approval process with clinical trials and extensive review of the design. Class 3 devices tend to be products such as pacemakers which would cause obvious risk of injury or death if they did not function properly. As with all devices, the manufacturers must follow the general controls.
History
In 1982, when the beginning of the biotechnology revolution blurred the lines between drugs, biologicsBiologics
A biologic is a medicinal product such as a vaccine, blood or blood component, allergenic, somatic cell, gene therapy, tissue, recombinant therapeutic protein, or living cells that are used as therapeutics to treat diseases...
, and medical devices, Commissioner Arthur Hayes reorganized the FDA. This reorganization merged the bureaus responsible for medical devices and radiation control into their present form, the Center for Devices and Radiological Health
Center for Devices and Radiological Health
The Center for Devices and Radiological Health is the branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices...
.
External links
- CDRH official government website