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Placing a Medical Device on the US Market

Placing a Medical Device on the US Market

Lady Liberty

Amy Eikelenboom

Co-founder of NAALA

Published on 25 August 2021

The 1975 Medical Device Amendments to the Food, Drug and Cosmetic Act (FD&C Act), established rules and standards for safety and effectiveness safeguards applicable to all US medical device manufacturers. The FD&C Act already gave the Food and Drug Administration (FDA) a mandate to establish requirement, but no provision was made for reviewing safety and effectiveness. To date, FDA’s Center for Device and Radiological Health (CDRH) is responsible for ensuring reasonably safe and effective medical devices on the US market.  

In the following years, numerous changes to device laws and regulations have been implemented via various FD&C Act amendments. With these amendments, the applicable rules accommodated to new types of devices, new environments and new technologies. 

What is the definition of a Medical Device

The term ‘device’ is defined as: “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory which is: 

  • Recognized in the official National Formulary, the US Pharmacopoeia, or any supplement to them, 
  • Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or 
  • Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within is not dependent upon being metabolized for the achievement of any of its primary intended purposes.” 

How are medical devices classified? 

The FD&C Act defines three classes of medical devices: 

  • Class I, requiring general controls; 
  • Class II, requiring general controls and special controls; 
  • Class III, requiring general controls and premarket approval. 

In addition, the FDA assigns a product code to a device category. These product codes are made available through CDRH’s product classification database which may help determine classifications.  

The classification of a medical device is dependent on the intended use and indications for use of a device and is risk-based. This risk level is determined by the control necessary to assure safety and effectiveness. 

Generally, Class I devices are considered of low risk. These are, for example, examination gloves. For these devices, general controls are sufficient. These general controls are requirements regarding: 

  • Adulteration or misbranding 
  • Electronic establishment registration 
  • Electronic device listing 
  • Premarket notification (510(k)) 
  • Truthful and accurate labeling 
  • Notification (recalls) 
  • Records and reports (adverse events, complaints, medical device reporting) 
  • Current Good Manufacturing Practice (CGMP) or Quality System Regulation (QSR) 

In general, these controls apply to all medical devices. It is, however, possible to be exempt from requirements. If this is the case, it must be stated in the device’s classification regulation. Most Class I medical devices are exempt from premarket notification and/or GMP regulation.  

Intermediate risk devices are mostly classified as a class II medical device. These are, for example, blood glucose test systems and infusion pumps. In addition to the beforementioned general controls, these devices require special controls dependent on the specific device. These special controls may include requirements regarding special labeling requirements, mandatory performance standards and post-market surveillance.  

Class III devices are high risk devices that are most of the time life-sustaining, life-supporting or implantable. In addition, devices with a new intended use or with new technology without a legally marketed predicate device are automatically classified as Class III. These devices require general controls, appropriate special controls and, in some case, premarket approval (hereinafter: “PMA”) 

What is required to enter the US market? 

Class I and II devices are either 510(k) exempt or require a 510(k) notification in order to market their product. Most Class III devices require a PMA. Any exceptions require only a 510(k). The FDA website and guidance documents provide information on the submission process of 510(k) and PMA.   

What is the difference between “cleared” and “approved”? 

There are various routes to market entry in the US, subject to the type of device to be marketed. Devices not subject to PMA may require a 510(k) Premarket Notification. A 510(k) is a premarket submission to the FDA in which the manufacturer demonstrates that the device to be marketed is at least as safe and effective, i.e. substantially equivalent, to another device already legally marketed. The important difference between 510(k) and PMA is that with 510(k) a manufacturer demonstrates that the device is as safe and as effective as a predicate device. With PMA, the manufacturer demonstrates the safety and effectiveness of the device itself. Via 510(k) the device is therefore “cleared” and not “approved”. 

 In case you are in need of determining your market access strategy in the US, feel free to contact us for more information. 

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only. Changes in legal or regulatory requirements may occur at short notice, which we cannot reflect on a daily basis. 

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