Pathways for IDE Approval: Which Best Fits Your Needs?

Pathways for IDE Approval: Which Best Fits Your Needs?

railsThere are several options for sponsors who are seeking IDE approval or FDA feedback regarding an IDE. Each option offers different benefits, depending on what type of trial the sponsor is seeking to initiate and how much time the sponsor is looking to invest in the process. Below is a table of the time, pros, and cons that each option offers. Flowcharts of each option are also listed to show the process involved in each option.

 Pathway Total Time (Best Case) Pros Cons
Pre-submission [1]105 days  75-90 days to get meeting scheduled with FDA after submission. 30 days submit IDE.
  • Good if all information is not yet complete for the IDE submission.
  • Good for specific questions on design.


  • Takes longer than IDE Submission/Pre-Decisional.
  • Very demanding on resources.
  • You run the risk of the FDA adding requirements.


Pre-Decisional [2]67 days 30 day review clock 15 days- FDA meeting 7 days convert to IDE 15 days approval
  • Good if trial is straight forward and must be pivotal.
  • Good to develop a trial design that may support a marketing approval/clearance.
  • Good if all data is ready for IDE submission.


  • Takes longer than IDE submission.
  • You run the risk of the FDA adding requirements.
IDE Submission [2]30 days  30 days to get FDA decision after submission.
  • Good if trial is straight forward pivotal or feasibility.
  • Time and resource efficient.
  • Offers staged approval/approval with conditions so enrollment can begin.


  • If the IDE gets disapproved, the process will have to start all over again.
  • Does not provide answers to design questions.
[1]Center for Devices and Radiological Health, Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff, Food and Drug Administration , 2014.
[2]Center for Devices and Radiological Health, DRAFT GUIDANCE FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations, Food and Drug Administration, 2013.

Pre-Submission Process

Pre-Submission Process

Pre-Decisional IDE Review Process

Pre-Submission Process Pre-Decisional IDE Review Process

IDE Submission Process

IDE Submission Process

What Does This Mean for You?

With so many options available for the submission of an IDE to the FDA, it can be difficult to decide which is best for your company. It may be tempting to go with the option that appears to have the shortest possible approval time; however this is not always clear. Each of the three options presented here can be tailored to fit the needs of your trial. For example, if you want to start the trial as soon as possible, the new offer for conditional approval of
studies allows enrollment to begin earlier. On the other hand, if your company wants to improve the chances of meeting the requirements for marketing approval in the future, the Pre-Decisional process may be the best choice. Careful consideration is needed to determine the best pathway for each client and each clinical trial. Boston Biomedical Associates can guide you through the decision making process, can assist in the submission of the IDE, and can help in executing the trial when the time comes. Feel free to contact us or follow us on Twitter @BBA_CRO.

Download the March 2014 Regulatory ENewsletter.

Stay tuned for our next E Newsletter, and please follow us on twitter @BBA_CRO

Mack Rubley


No Comments

Post A Comment