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...

1. A Regulatory Strategy for your
Medical Device
By: Haley Fenn
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.i 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.ii
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.iii The outcome can also determine

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the reimbursement strategy for the product, whether it can be reimbursed by public or private
payers, or paid out of pocket.iv
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!
i Van 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
ii TREAT 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
iii TREAT 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
iv TREAT Center for Translation of Rehabilitation EngineeringAdvances and Technology.Commercialization Process:
Regulatory Strategy retrieved on (01/15/2020) from https://www.treatcenter.org/edu/commercialization-
process/regulatory-strategy/