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Product Classification

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Product Classification

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The three classes and the requirements which apply to them are:

Device Class and Regulatory Controls

  • Class I General Controls  (With Exemptions, Without Exemptions)

  • Class II General Controls and Special Controls (With Exemptions, Without Exemptions)

  • Class III General Controls and Premarket Approval


The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market. If your device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing. All devices classified as exempt are subject to the limitations on exemptions. Limitations of device exemptions are covered under Parts 862-892. For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) and PMA's have not been called for. In that case, a 510k will be the route to market.

Device classification depends on the intended use of the device and also upon indications for use. For example, a scalpel's intended use is to cut tissue. A subset of intended use arises when a more specialized indication is added in the device's labeling such as, "for making incisions in the cornea". Indications for use can be found in the device's labeling, but may also be conveyed orally during sale of the product.  In addition, classification is risk based, that is, the risk the device poses to the patient and/or the user is a major factor in the class it is assigned. Class I includes devices with the lowest risk and Class III includes those with the greatest risk. As indicated above all classes of devices as subject to General Controls. General Controls are the baseline requirements of the Food, Drug and Cosmetic (FD&C) Act that apply to all medical devices, Class I, II, and III.

C. Humphrey & Associates, P.A.  is an FDA Law Firm that represents domestic and international companies regarding a range of regulatory medical device law issues before federal and state agencies and courts involving the U.S. Food & Drug Administration (FDA), Federal Trade Commission (FTC) and U.S. Customs Border & Protection (CBP). Our FDA law firm provides regulatory counsel to clients in all phases of medical device product development and marketing. We have represented medical device firms, including manufacturers, distributors, and importers, in all facets of device regulation and compliance.  

Our FDA Lawyers and FDA Consultants assist in array of FDA Legal Services for manufacturers and distributors of medical devices including:

  • Clinical trials of medical devices under Investigational Device Exemption (IDE) regulations

  • FDA classifications of medical devices and labeling issues

  • Preparation of pre-market approval applications (PMAs), 510(k) Notifications and Humanitarian Device Exemptions (HDEs)

  • Establishment registration and listing applications

  • Combination products

  • Medical Device Reports (MDRs), product recalls, market withdrawals, FDA site inspections and Quality System Regulation (QSR)    requirements

  • Development of pre-market approval and FDA clearance strategies

  • Drafting and negotiating clinical trial, lab services, manufacturing and supply agreements

  • FDA Import Alerts for Medical Devices

  • Compliance issues relating to current Good Manufacturing Practices (cGMP), record keeping and product recalls

  • FDA Inspections for Medical Devices

  • Defending against FDA and FTC administrative and enforcement actions (e.g. FDA Warning Letters, FDA seizure, FDA injunction, FDA   criminal and civil penalties)


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