Understanding the regulatory pathway for a new medical or drug delivery device can be confusing. Gilero’s in-house experts can provide guidance and recommendations for classifying your product, 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.


Quality & Regulatory Services

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

Our Regulatory Approach


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.


Once the 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 these agencies early in the development process to further clarify and confirm our approaches to device testing, human factors engineering, clinical trials, etc.


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.


As part of our regulatory consulting services, once all the proper documentation is completed, Gilero can file the submission with the applicable regulatory body on behalf of our client, if requested. In addition, Gilero can lead correspondences and responses required until the product is cleared or approved for the market.


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

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