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Obtain FDA Clearance for Medical Devices

Our FDA consultants work with you to determine the best route to market for your product and your business with support throughout the entire FDA clearance process.

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

Although this is not an exhaustive list, some of the activities you may perform along the path to FDA clearance are outlined below:

Product Analysis and Regulatory Roadmap

  • Identify if your product is a medical device, In-Vitro Diagnostic device, or a combination product (a medical device used with a pharmaceutical product)
  • Understand the product’s intended use and indications for use
  • Determine or confirm your product’s risk classification (Class I, II or III) and product code, which may require you to:
    • Develop the appropriate justification for whether your product is 510(k) exempt or GMP exempt; or
    • Evaluate and establish the risk profile foundations justifying a de novo pathway, if appropriate; or
    • Justify a PMA pathway, if necessary

Planning for FDA Clearance

  • Assess and leverage existing information you have created that supports your submission
  • Identify and prepare additional materials necessary for FDA review
  • Identify studies and testing that might be necessary
  • Plan FDA communications

FDA Pre-Submission Activities

  • Plan Pre-Submission meetings with the FDA, which might include conversations about:
    • Investigational Device Exemption (IDE)
    • Clinical Studies
    • Clinical Trials
    • Human Factors Validation Testing
    • 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 test plans, including proposed clinical testing, are adequate.

Submission Filing

  • 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
  • Address post submission FDA queries

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 listThen, contact us to have a conversation about how we can support your FDA submission process.

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