ANSWERED ON THIS PAGE:
- How can we determine FDA testing requirements for our medical device or IVD?
- What is the FDA Pre-Submission Program?
- Is Pre-Submission Consulting required?
The US Food and Drug Administration's Pre-Submission Program (Pre-Sub, formerly known as the Pre-IDE Program) allows medical device and in vitro diagnostic (IVD) manufacturers to discuss specific aspects of the regulatory process and requirements with FDA experts. A Pre-Sub is commonly referred to as a Q-Sub, as the submission to the FDA is assigned a 'Q' identification number. Emergo's experienced US consulting team has extensive expertise with the FDA Q-Sub process. We can guide you through this critical step toward FDA clearance.
How the FDA pre-sub process can help you achieve US market clearance for your device
FDA Pre-Sub consulting is available for sponsors and manufacturers to obtain regulatory feedback on various medical device- or IVD-related applications, including Investigational Device Exemptions (IDE) necessary for high risk medical device clinical investigations, premarket notification (510(k)) submissions, and clinical or non-clinical study protocols.
Topics that may be addressed using the Pre-Sub process include, but are not limited to, the following:
- Specific preclinical performance testing required to support pre-market clearance or approval application.
- The appropriate regulatory path for a novel device, such as the 510(k) route or a de novo application.
- The formal designation of a device clinical study as either "significant risk" (SR) or "non-significant risk" (NSR).
The FDA Pre-Sub program can prove especially valuable for devices utilizing novel technologies, or those with indications that qualify them as "first of a kind" devices.
How and when to start the FDA Q-Submission process
You must formally request a Pre-Sub meeting with the FDA. The contents of your Q-Sub submission for requesting a meeting should include a cover letter, a thorough description of your medical device along with its proposed intended use, the mechanism of action on the body, its technological characteristics, your planned testing strategy, and specific questions on which you are requesting input from the FDA.
You must submit your Pre-Sub meeting request before submitting your 510(k) or premarket application (PMA) review process, or before beginning a clinical study on which you are seeking feedback. There are other 'Q-Sub' meeting types that allow you to meet with the FDA for different purposes (e.g., Submission Issues meeting during the review process). However these are not as common.
Pre-Sub meeting submission consulting
The steps to a successful Pre-Sub meeting with the FDA vary somewhat by device. Emergo can help you get the most benefit from the Pre-Sub Meeting process. Our services include:
- Assist in developing the specific questions to the FDA for which their feedback is requested.
- Assist in preparing Pre-Sub documentation and provide feedback on items such as intended use statement, draft product labels and Instructions for Use, etc.
- Review and provide feedback on proposed clinical or animal study protocols, non-clinical bench testing protocols, usability protocols, and performance testing protocols, as well as previous clinical data and peer-reviewed publications.
- Compile the Pre-Sub meeting request package and submit to the FDA to request a Pre-Sub meeting in-person at the FDA headquarters or by conference call.
- Assist in the preparation for the meeting, including providing feedback on presentation materials and practicing for anticipated questions by the FDA.
- Participation in the Pre-Sub in-person meeting or conference call with the FDA. The Emergo consultant will be available for consultation and support throughout the meeting and may address the FDA on the client's behalf (particularly useful if a language barrier is an issue) at the client's request.
- Provision of a second consultant to take notes during the Pre-Sub meeting or conference call (this is via phone conference connection only).
Through our US and European consulting teams, Emergo is well equipped to assist medical device and IVD manufacturers as well as study sponsors through the FDA Pre-Sub process.
Are FDA Q-Sub meetings required?
Pre-Sub meetings are not mandatory. However, early interaction with FDA regarding testing strategy or clinical study protocol, along with careful consideration of the FDA's feedback, is encouraged to facilitate an effective development process for new devices and improve the quality of the subsequent premarket submissions.
Are Pre-Sub meetings conducted in-person?
You may request a Pre-Sub meeting in the form of a face-to-face meeting or a teleconference with appropriate FDA personnel, or you may simply request feedback via an email response. The type of meeting is often defined by the type of device and the specific questions being posed to the FDA. If possible, a face-to-face meeting, that occurs at the FDA offices in Maryland, is usually advisable; however, a well-planned conference call can be just as effective.
Additional services for United States: