Office of In Vitro Diagnostics and Radiological Health
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 devices, 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.
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 a premarket notification. This process, commonly known as the "510(k)" process after the relevant section of the Food, Drug and Cosmetic Act, results in FDA clearance of a product. 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 premarket notification 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 cleared 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.
In 1982, when the beginning of the biotechnology revolution blurred the lines between drugs, biologics, 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.
- International Organization for Standardization
- Zuckerman et al. "Medical Device Recalls and the FDA Approval Process." Arch Intern Med. 2011; 0: 2011301-6. PMID 21321283
- Redberg and Dhruva. "Medical Device Recalls: Comment on 'Medical Device Recalls and the FDA Approval Process.'" Arch Intern Med. 2011; 0: 2011271-2. PMID 1321286
- Reid, Ken. "CBER and CDER have long history of being lumped together and split up." Bioresearch Monitoring Alert Sept. 2002. page 4.