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FDA Sherpa

Sherpa identifies the appropriate pathway for FDA clearance of your device and provides a comprehensive overview of applicable requirements

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Discover FDA Sherpa’s Key Features 

Device classification

Identify your product code(s) out of +6000 options in minutes

  • Structured search through regulations, +product codes and approved devices
  • In depth evaluation of questions of safety and effectiveness
  • Clear rationale and recommendation for a single product code, combination of codes or no suitbale code

Submission pathway

Understand which submission is applicable depending on product code and applicable special controls

  •  Identifies which submission is applicable (510k, DeNovo, PMA, HDE)
  • Navigates possible cases whether single, multiple or no product codes apply
  • Evaluates application of new class II special controls for De Novo

Breakthrough and SteP

Make sure you don’t mis out on FDA’s accelerated review programs

  • Provides in expert analysis of elligibility to Breakthrough Designation and SteP programs
  • Detailed rationale that you can directly use to build your submission

Predicate device

Find the best predicate and generate your susbtantial equivalence table

  • Structured search through 100k approved devices
  • In depth evaluation of question of safety and effectiveness
  • Check against MAUDE database
  • Creates draft substantial equivalence table

Guidances

 Deep-dive any specific topics across +2700 FDA guidances

  • Get an overview of guidances applicable to your product
  • Answer any question about a specific guidance or topic
  • Detailed summary of applicable recommendations for each guidance

Requirements

Get a comprehensive view of the regulatory controls & consensus standards for your product

  • Get a comprehensive view of the regulatory requirements for your product
  • Covers general controls and product specific controls
  • Get an overview of recognized consensus standards applicable to your product
  • Detailed rationale witht the scope of the standard and rationale why it applies

FDA clearance is based on complex regulatory precedence analysis. Now made easy.

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