The FDA has recently released a draft guidance titled “Medical Devices: The Pre-Submission Program and Meetings with FDA Staff” that will update and expand the pre-IDE program established in 1995 and the associated Blue Book Memo from 1999. The program will be renamed the Pre-Submission, or Pre-Sub, program, and will be broadened to include other device submissions, including PMA applications, HDE applications, and 510(k) Submissions.
The guidance states:
“A Pre-Submission is defined as a formal written request from an applicant for feedback from FDA to be provided in the form of a formal written response or, if the manufacturer chooses, a meeting or teleconference in which the feedback is documented in meeting minutes”
Sponsors are provided with information about the Pre-Sub program, including the voluntary nature of the submission, when it is appropriate to submit a Pre-Sub package and what the package should contain. Below are some highlighted aspects of the Pre-Sub program:
- Useful before conducting clinical, nonclinical or analytical studies or an IDE or marketing application, particularly when novel technology or in vitro diagnostics are involved
- Recommended when input is desired on nonclinical study protocols or planned clinical studies
- Valuable for obtaining feedback on preferred data presentation or potential hurdles for approval/clearance
The Pre-Sub package should contain information about the device, its intended use, and product development, as well as previous submissions or discussions with the agency. The guidance also provides examples for package components and example questions for Pre-Subs related specifically to IDE, 510(k), PMA, HDE, and IVD submissions/applications.
The limitations of the Pre-Sub program and the other resources available through the FDA are also spelled out in the new guidance. Below is a selection of recommendations that Sponsors should consider prior to creating a Pre-Sub package. The Pre-Sub program:
- Is not an alternative to other review processes and does not substitute for research of current medical device development practices
- Is not meant to be an iterative process. Its goal is to provide one-time advice on a particular topic. If more than one Pre-Sub is planned for a device, the initial Pre-Sub should contain an overview of expected submissions
- Is not meant for general questions regarding FDA policies or for holding informational meetings or teleconferences
- Is not a procedure for jurisdictional assignment of a combination product or determining the class of a device
The FDA emphasizes that early interaction and careful consideration of the agency’s feedback may improve the quality of subsequent submissions and facilitate the development process for new devices.
What are your thoughts on the new guidance? What are your experiences with the former pre-IDE program? Share your comments with us!
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