{"id":55628,"date":"2022-07-22T14:01:20","date_gmt":"2022-07-22T18:01:20","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/medical-devices-101-controls-and-classifications\/"},"modified":"2022-07-22T14:01:20","modified_gmt":"2022-07-22T18:01:20","slug":"medical-devices-101-controls-and-classifications","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/pt\/medical-devices-101-controls-and-classifications\/","title":{"rendered":"Medical Devices 101: Controls and Classifications"},"content":{"rendered":"

In this 3-part series, we explore the basic foundations of FDA\u2019s regulation of Medical Devices. Topics include Controls and Classifications, Premarket Notification 510(k), and Premarket Approval (PMA).\u00a0<\/span><\/i>\u00a0<\/span><\/p>\n

Before marketing a medical device in the United States, manufacturers should first gain a solid understanding of how the U.S. Food and Drug Administration (FDA) classifies medical devices.\u00a0 FDA divides medical devices into classes that determine the regulations a device is subject to, providing a blueprint for the path to legally marketing that device in the U.S.\u00a0<\/span>\u00a0<\/span><\/p>\n

Medical device classifications indicate what controls apply to a device and what regulatory submission, if any, is needed to market the device. When a device is subject to certain controls and\/or submission requirements, these requirements must be strictly adhered to.\u00a0<\/span>\u00a0<\/span><\/p>\n

If a manufacturer markets a medical device without applying the applicable controls or obtaining approval for applicable regulatory submissions, FDA considers the device to be adulterated or misbranded and the device is subject to FDA\u2019s enforcement actions.\u00a0<\/span>\u00a0<\/span><\/p>\n

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Get assistance with FDA compliance.<\/h3>\n

Registrar Corp\u2019s Regulatory Specialists help companies comply with FDA requirements, including regulations for Medical Devices.<\/p>\n

For assistance with FDA regulatory requirements, call: +1-757-224-0177, email: info@registrarcorp.com<\/a>, or chat with a Regulatory Advisor 24-hours a day: regstaging.wpengine.com\/livechat<\/a>.<\/p>\n

Get Assistance<\/a><\/p>\n<\/div>\n

Read on to learn more about FDA\u2019s medical device classifications and what controls and submission requirements apply to each class.\u00a0<\/span><\/span>\u00a0<\/span><\/p>\n

Medical Device Definition<\/span><\/b>\u00a0<\/span><\/p>\n

A medical device can come in the form of an instrument, apparatus, machine, implant, in vitro reagent, or other similar or related article, including a component part, or accessory. Medical devices are intended for use in the diagnosis of disease or in the cure, mitigation, treatment, or prevention of disease in man or other animals or to affect the structure or any function of the body of man or other animals.\u00a0<\/span>\u00a0<\/span><\/p>\n

A medical device does not achieve any of its primary intended purposes through chemical actions within or on the body of man or other animals and is not dependent on being metabolized to achieve its purpose.\u00a0\u00a0<\/span>\u00a0<\/span><\/p>\n

Classifications\u00a0<\/span><\/b>\u00a0<\/span><\/p>\n

Along with the level of risk the device poses, device classification also depends on the device\u2019s\u202fintended use\u202fand indications for use<\/span>.\u202f<\/span> Classifications and requirements are as follows:\u00a0<\/span>\u00a0<\/span><\/p>\n

Class 1<\/span><\/b>: General controls only<\/span>\u00a0<\/span><\/p>\n