Editing Food and Drug Administration (section)

===Medical and radiation-emitting devices===
{{more citations needed section|date=August 2019}}
[[File:FDA Bldg 62 - Exterior (5161375340).jpg|thumb|FDA Building 62 houses the [[FDA Center for Devices and Radiological Health|Center for Devices and Radiological Health]].|alt=]]
The [[Center for Devices and Radiological Health]] (CDRH) is the branch of the FDA responsible for the premarket approval of all [[medical device]]s, as well as overseeing the manufacturing, performance and safety of these devices.<ref>{{cite web | url = https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/ucm300639.htm | title = CDRH Mission, Vision and Shared Values | archive-url = https://web.archive.org/web/20190422142129/https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/ucm300639.htm | archive-date=April 22, 2019 | access-date = August 30, 2012 | publisher = U.S. Food and Drug Administration }}</ref> The definition of a medical device is given in the FD&C Act, and it includes products from the simple [[toothbrush]] to complex devices such as implantable [[neurostimulator]]s. CDRH also oversees the safety performance of non-medical devices that emit certain types of [[electromagnetic radiation]]. Examples of CDRH-regulated devices include [[cellular phones]], [[Airport security|airport baggage screening equipment]], [[television|television receivers]], [[microwave oven]]s, [[tanning booth]]s, and [[laser|laser products]].<ref>{{Cite web |date=June 13, 2022 |title=FDA Center for Devices and Radiological Health (CDRH) - NCI |url=https://sbir.cancer.gov/commercialization/fda/radiological-devices |access-date=January 2, 2025 |website=sbir.cancer.gov |language=en}}</ref>

CDRH regulatory powers include the authority to require certain technical reports from the manufacturers or importers of regulated products, to require that radiation-emitting products meet mandatory safety performance standards, to declare regulated products defective, and to order the recall of defective or noncompliant products. CDRH also conducts limited amounts of direct product testing.

===="FDA-Cleared" vs "FDA-Approved"====
Clearance requests are required for medical devices that prove they are "substantially equivalent" to the predicate devices already on the market. Approved requests are for items that are new or substantially different and need to demonstrate "safety and efficacy", for example they may be inspected for safety in case of new toxic hazards. Both aspects need to be proved or provided by the submitter to ensure proper procedures are followed.<ref>{{cite web |url=https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194460.htm |title=What does it mean when FDA "clears" or "approves" a medical device? |publisher=Food and Drug Administration |access-date=March 14, 2015 |archive-date=March 7, 2015 |archive-url=https://web.archive.org/web/20150307000034/http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194460.htm |url-status=live}}</ref>