Regulatory Strategy

Commercialization Process: Regulatory Strategy


A Regulatory Strategy describes the approach that will be used to meet regulatory and industrial standards and third party insurance payment for the product. For medical devices this means a plan for achieving US Food and Drug Administration (FDA) clearance and determining who will pay for this product, whether it can be reimbursed by public or private payers, or if it must be paid for out of pocket. The outcome of this stage is a Regulatory Plan to move the device forward in a strategically appropriate manner for the business, while following required guidelines.

How this Milestone Reduces Project Risk

Technologies cannot be sold unless they meet regulatory requirements, and any development that does not comply with the relevant regulatory bodies would need to be redone. Developing within a sound Regulatory Strategy prevents fatal errors.

What to consider at this time

What are the relevant regulatory bodies and industrial standards for the technology? Are there additional clinical guidelines that could impact development?

Ready to start?

In the FDA Regulatory module you will learn how to:

  • Research predicate devices.
  • Determine and verify target device classification.
  • Develop a regulatory strategy for FDA clearance.
FDA Regulatory Guide

Learn about relevant resources for developing and marketing a FDA regulated medical device.

Regulatory Strategy Reading

Why do some products have to be regulated? Take a deeper dive into understanding US FDA regulation and strategies to comply with regulations in this reading.

Indications for Use (IFU) Worksheet

Use this worksheet to record your plans for device use. This will be a reference point throughout your regulatory assessment.

Predicate Device Search Worksheet

While searching FDA databases for similar or predicate devices, use this worksheet to document your efforts.

Predicate Device Decision Worksheet

This decision matrix worksheet will help to list multiple potential predicates and identify similar IFU or technical characteristics.

Regulatory Plan Worksheet

After identify a predicate device and if you are still considering multiple strategies, use this worksheet to weigh the advantages and disadvantages of different regulatory pathways.

Understanding and assessing medical device reimbursement

After reviewing the Reimbursement Planning & Strategy module you should:

  • Understand coverage schemes for the technology.
  • Identify a code or multiple codes that could be used in insurance billing for the technology.
  • Understand historical payment amounts for selected codes.
Reimbursement Supplemental Reading

Why is reimbursement important and where does it fit in the product development process? Learn more in this supplemental reading.

Reimbursement Planning & Strategy Guide

Begin your reimbursement planning by learning how to identify existing coding and insurance coverage for your device.

Existing Code and Payment Search Worksheet

Use this worksheet alongside the reimbursement planning and strategy guide to document your search results for existing coding and payment amounts.