Solutions That Drive FDA Clearance

MethodSense FDA Clearance Consultants

The path to medical device commercialization and FDA clearance is determined by many factors. Usually this means filing 510(k) pre-market notification with the FDA. However, in some instances, it might mean taking a PMA or de novo path to market.

Our FDA consultants work with you to determine the best route to market for your product and support you throughout the entire process – which can get quite complicated depending on the characteristics and intended use of your device. While there are different activities that must be completed, medical device human factors studies included, many happen concurrently. Although this is not an exhaustive list, some of the activities you may perform are outlined below:

  • Identify if your product is a medical device
  • Determine or confirm your product code and classification (Class I, II or III)
    • Class I or Class II devices may be FDA exempt, follow a 510(k) path, or follow a de novo pathway
    • Class III devices follow a PMA route
    • In some cases, a predicate may not be available. When this occurs, we evaluate whether the de novo pathway is an available route for your product.
  • Assess existing information you have created that will support your submission
  • Identify and prepare additional materials necessary for FDA review
  • Identify studies and testing that might be necessary
  • Plan FDA communications
  • Plan Pre-Submission meetings with the FDA, which might include conversations about:
    • Investigational Device Exemption (IDE)
    • Clinical Studies
    • Clinical Trials
    • Medical Device Human Factors Studies
    • Safety Testing
    • Software Validation
    • System Verification & Validation
  • Prepare protocols and manage projects related to Pre-Submission meetings
  • Conduct Pre-Submission meetings with the FDA to answer open questions, such as whether a de novo pathway as a Class II device would be considered acceptable and to confirm if the proposed clinical testing is adequate.
  • Ensure the appropriate records and documents have been generated to support the PMA, 510(k) or de novo submission.
  • Prepare the application
  • File the submission

We guide clients throughout the entire FDA clearance process – as well as at any stage. To help get you started, we recommend you review our 510(k) action list.

To have a conversation about how we can support your FDA submission process.

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