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Who regulates medical devices in the United States?

Who regulates medical devices in the United States?

The United States (U.S.) Food and Drug Administration (FDA) is responsible for ensuring that medical devices (including in vitro diagnostics) and radiation-emitting electronic products comply with applicable U.S. regulations when offered for importation into the United States. [2]

Similarly one may ask, Which drug agency is responsible to regulate medical devices? The U. Medical devices are regulated by the Food and Drug Administration (FDA) to ensure their safety and effectiveness, and to develop a national program to prevent unnecessary exposure to, and ensure safe and efficacious use of, ionizing and non-ionizing radiation-emitting electronic devices. [6]

Furthermore, What are the regulations for medical devices? - Assign a UDI to the device and its packaging by 26 May 2025 - Designate a Person Responsible for Regulatory Compliance meeting the article 15 qualification requirements - For non-EU manufacturer sign a contract with an Authorized Representative located in an EU Member State [7]

Beside above, What are regulatory requirements for a medical device? - Where you plan to go to market. The regulations your medical device is subject to will depend on where exactly you plan to sell your device. ... - Your device’s components. Will your device be electrically wired? ... - Your device’s interaction with the human body. ... - Your device’s environment. ... [8]

Thereof, Are medical devices regulated by the FDA? The FDA has asked for comments on reporting requirements for firms that intend to export certain unapproved medical devices from the U.S. The Food, Drug and Cosmetic Act allows for exportation of a device that is not FDA-approved if the exporting company ... [9]


  • fda.gov, Importing Medical Devices and Radiation-Emitting.
  • nursa.org, Which Drug Agency Is Responsible To Regulate Medical ....
  • linkedin.com, FDA Regulation of Medical Devices.
  • mindflowdesign.com, What Regulatory Requirements Does Your Medical Device Need?.
  • wfmz.com, FDA Invites Comments on Reporting Requirements for Firms that Export Unapproved Medical Devices.
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Author João CardosoHello, my name is João Cardoso. I am a 32 years old Blogger & certified Computer Engineer from Portugal and currently doing Masters in Networks Security from the University of Lisbon.