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Regulatory Support

Understanding the regulatory pathway for a new medical device or combination product can be confusing. Gilero’s in-house regulatory experts provide guidance and recommendations for classifying your device, while considering the intended use, technology, regulatory landscape and commercialization strategy. With this assessment in hand, the output of our design and development process provides a complete package for regulatory submissions and transfer into commercial production.

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Our Regulatory Approach

Assess

The first step in Gilero’s regulatory approach is understanding the intended use and technology of the customer’s medical device or drug delivery/combination product. Our team will then conduct a regulatory assessment, defining the regulatory pathway for the product. This may include device classification, identification of a predicate device, determination of the primary mode of action (for combination products) or defining other regulatory requirements.

Strategize

Once the regulatory pathway has been defined, our internal experts will align the outputs of our design and development process to ensure that documentation and testing will support future regulatory submissions. Gilero can prepare and facilitate correspondence with regulatory bodies through activities such as pre-submission meetings to address any open questions. In certain cases, it can be beneficial to receive feedback from regulatory agencies early in the development process to further clarify and confirm our approaches to device testing, human factors engineering, clinical trials, etc.

Next: Prepare & Submit

Prepare

Gilero can prepare and maintain design history files or device master files, which offer evidence of the evolution of the design and assessment of risk throughout the development process. For combination products, we focus on documentation required for the device and interactions between the drug/device or biologic/device. This, paired with the drug side, offers a comprehensive package for our customers developing combination products.

Submit

Once all regulatory documentation is completed, Gilero can file the submission with the applicable regulatory body on behalf of our customer, if requested, and lead correspondences and responses required until the product is cleared or approved for the market.

Next: Support

Support

After regulatory submission, Gilero can provide ongoing regulatory consultation services throughout a product’s life cycle, or as new requirements are published by regulatory agencies.

Regulatory Strategy

  • Regulatory assessments
  • Medical device classification
  • US FDA strategy
  • EU and Canadian strategy
  • Selection of predicate device(s)
  • Determination of primary mode of action (PMOA) for combination products
  • Office of Combination Product (OCP) Request for Designation (RFD)
  • Identification of applicable consensus standards and guidance documents
  • Significant/non-significant risk designation for investigational devices
  • Investigational Review Board (IRB) documentation
  • Labeling content and layout design, including Instructions for Use (IFUs)
  • Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER)
  • Postmarket Clinical Followup (PMCF), Postmarket Surveillance Report

Regulatory Submissions

  • 510(k)
  • PMA (Pre-market approval)
  • De novo
  • Technical files, for CE Marking in the EU
  • Investigational device exemption (IDE)
  • Pre-IND and IND (Investigational New Drug) for combination products
  • NDA or ANDA (New Drug Application/Abbreviated New Drug Application) for combination products

Read More on Our Blog

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