A Regulatory Strategy for your Medical Device

A Regulatory Strategy for your Medical Device

Laying out a regulatory strategy for your product that visualizes the steps taken to bring a new or modified product to market could be one of the smartest decisions you can take as a start-up company. The regulatory strategy describes the approach that will be used to meet the regulatory requirements, as well as known industrial standards.

Not knowing the process or the steps to enter your product into the market can cause mistakes and headaches. The FDA can reject regulatory submissions if they are not complete or accurate. FDA submissions can cost anywhere from thousands to millions of dollars depending on the pathway taken.1 With this, choosing the correct strategy and pathway for the product the first time around can save you time and money.

Understanding the correct regulatory requirements in the early steps of product development will ensure successful commercialization. Early product development planning with a concrete regulatory strategy provides valuable input to the design of the device, risk assessment, testing, and labeling.2

The first step of a regulatory strategy is to identify the characteristics of the device. The classification, intended use, type of market, and the level of risk of the medical device can determine the best pathway to market. In order to correctly identify the proper pathway, you must ask yourself these questions:

  • Is your product a medical device?
  • Is the device considered class I, II, or III?
  • Is there a similar or predicate device already on the market?
  • Is the device high or low risk?
  • Does the device interest a small or large market?

The questions above can help define your product and set you on the right track to commercialize your medical device.

Filing a Pre-Submission is a great tool to receive feedback from the FDA on your product and the potential pathway. The outcome of your regulatory strategy will prepare you for your FDA Submission, including a timeline and anticipated clearance.3 The outcome can also determine the reimbursement strategy for the product, whether it can be reimbursed by public or private payers, or paid out of pocket.4

Having an effective team to help navigate through the correct regulatory strategy for your medical device is vital to your success in commercializing your product.

EMMA International can provide you with a robust regulatory pathway for your medical device. Contact us at info@emmainternational.com or 248-987-4497 to see how we can help!


1Van Batavia, J., & Goldenberg, S. J. (2019). Strategic Planning and Costs of FDA Regulation. Academic Entrepreneurship for Medical and Health Scientists, 1(2), 8 retrieved on (01/15/2020). From https://repository.upenn.edu/cgi/viewcontent.cgi?article=1050&context=ace

2TREAT Center for Translation of Rehabilitation Engineering Advances and Technology. Regulatory Strategy Supplemental Reading retrieved on (01/15/2020) from http://treatcenter.org/wp-content/uploads/2018/04/2-Regulatory-Strategy-Supplemental-Reading.pdf

3TREAT Center for Translation of Rehabilitation Engineering Advances and Technology. Regulatory Strategy Guide Overview retrieved on (01/15/2020) from http://treatcenter.org/wp-content/uploads/2018/04/1-Regulatory-Strategy-Guide.pdf

4TREAT Center for Translation of Rehabilitation Engineering Advances and Technology. Commercialization Process: Regulatory Strategy retrieved on  (01/15/2020) from https://www.treatcenter.org/edu/commercialization-process/regulatory-strategy/

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