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Medical Device: To Enter USA Market Cheat Sheet (DRAFT) by [deleted]

What is needed to break into the U.S. market?

This is a draft cheat sheet. It is a work in progress and is not finished yet.


Although most medical devices enter the United States market by obtaining either 510(k) clearance or Premarket Approval (PMA), there are other paths available, which are less frequently invoked. Below are high-level descri­ptions of pathways available to device companies.

1. 510(k) Notifi­cation

Devices that present relatively low risk (i.e., such as class I or class II) require the manufa­cturer to seek 510(k) clearance from the FDA, unless exempted from this requir­ement by regula­tion. Such clearance is generally granted when a new device is “subst­ant­ially equiva­lent” in intended use and techno­logical charac­ter­istics to a “predicate device,” which is generally a legally marketed class I or class II device. Products that are exempt from 510(k) clearance may enter the market so long as they are within the parameters defined by its predicate devices within the classi­fic­ation.

2. Premarket approval (PMA)

A medical device that does not qualify for 510(k) clearance is placed, by default, in class III, which is reserved for devices classified by the FDA as posing the greatest risk (e.g., life-s­ust­aining or implan­table devices, or devices that are not substa­ntially equivalent to a predicate device). For these devices, the product must be approved via the premarket applic­ation (“PMA”), which requires that the safety and effect­iveness of the device be establ­ished with valid scientific evidence, normally high-q­uality clinical data.

3. De Novo review

FDA will consider the de novo pathway for novel devices when the de novo requester either determines that there is no predicate device (“direct de novo”) or has its device found not substa­ntially equiva­lent. To be eligible, the device must be low to moderate risk, such that general or special controls would provide reasonable assurance of the safety and effect­iveness of the device.

4. Humani­tarian device exemption (HDE)

The HDE program encourages device companies to bring treatments onto the market for conditions that affect small popula­tions. Humani­tarian use devices (HUDs) are limited to treating or diagnosing conditions that affect fewer than 4,000 people in the U.S. per year. The approval process is similar to a PMA except that the applic­ation is only required to demons­trate safety and probable benefit of the therapy.

5. Invest­iga­tional device exemption

An Invest­iga­tional Device Exemption (IDE) allows a manufa­cturer to provide an invest­iga­tional device to be used in a clinical study in order to collect safety and effect­iveness data. All invest­iga­tional clinical studies, unless exempt, must have an approved IDE. An IDE can be obtained through submission of an IDE applic­ation, which includes, for example, a clinical protocol and informed consent documents. Some studies that present nonsig­nif­icant risk may proceed without an IDE if approved by the Instit­utional Review Board (IRB).

6. Expanded access; Compas­sionate use & emergency

The expand­ed-­access option allows an invest­iga­tional device to be used, outside of a clinical trial, where a physician determines that a seriously ill patient requires use of the device and there are no generally accepted altern­atives. Under the Emergency Use provision, a device that is needed immedi­ately is exempted from FDA approval. Under the Compas­sionate Use provision, FDA approval is still required.

7. Custom device exemption (CDE)

The custom device exemption allows manufa­ctures to provide a device(s) to meet a particular patient or surgeon need in treating a unique condition in the absence of a commer­cially available medical device. No more than five custom devices within a device type may be manufa­ctured per year.