The U.S. Food and Drug Administration (FDA) has the authority over the market entrance of medical devices. This includes the determination of whether devices are safe and effective. The classifications, pathways, and submissions associated with medical devices are quite different than those provided for pharmaceutical products. This includes 510 k premarket notification .   

FDA classifies devices into three classes, based upon their potential risk and the regulatory controls required for the device. Class I devices pose the least risk to the public and for which safety and effectiveness are addressed with General Controls. Such controls include maintaining proper Quality System Regulations (QSR) adherence, facility registration, product listing, reporting of adverse events, and other basic requirements.  These devices usually do not require specific FDA clearances (510(k)) or approvals (Premarket Approval (PMA)) to bring the product to market.  Class II devices are considered to pose intermediate risks and generally require premarket clearance by FDA 510(k) submissions. Class II device manufacturers may be required to conform to certain performance standards, FDA Guidances, specific labeling, tracking, etc. as well as general controls. FDA clearance requires that a Class II product submitted pursuant to the 510(k) procedure be shown to be substantially equivalent (SE) to its predicate device. Class III devices present the greatest risk to the public and may include life-sustaining devices, life support measures and permanent devices. These products must conform to general controls and must be specifically approved prior to marketing through the PMA process, often including clinical trial data to support that the device is safe and effective.

In contrast to the PMA approval process, FDA requires that a product marketed via the 510(k) process demonstrate substantial equivalence to a predicate device or devices. A predicate device is a legally U.S. marketed device not subject to a PMA. For a new device to be deemed SE, it must be at least as safe and effective as the predicate. An SE product is determined to have the same intended use as its predicate and may or may not have the same technological characteristics as its predicate. 

The 510(k) process does not include a finding by the FDA that a medical device is safe and effective. Rather, the 510(k) process is focused on a determination that the proposed medical device:

  • is SE to a product already on the market
  • does not raise new questions of safety and effectiveness
  • is at least as safe and effective as the legally marketed device

FDA evaluates the commercial manufacturing and control procedures developed, validated, and maintained by sponsors to ensure that these 510(k) products comply with current Good Manufacturing Practices (GMP) and QSRs. Manufacturers must comply with GMPs and QSRs at launch and throughout the commercial lifecycle of their devices. For many medical devices, the 510k submission is the appropriate pathway to the marketplace in the U.S. Knowledgeable and experienced 510k consultants, such as those at BRG, can guide companies/sponsors through the process and manage all submissions to FDA. Additionally, BRG can perform all post-clearance regulatory activity and FDA interactions needed for any of your device products.      

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