The US Food and Drug Administration offers Pre-Submission Consulting (Pre-Sub consulting, formerly known as Pre-IDE consulting) for medical device and in vitro diagnostic (IVD) manufacturers before they begin their regulatory application or clinical and non clinical testing. A Pre-Sub is also now commonly referred to as a Q-Sub, as the submission to the FDA is assigned a ‘Q’ identification number.
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. 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. A device or IVD manufacturer may request a Pre-Sub meeting in the form of a face-to-face meeting or a teleconference with appropriate FDA personnel, or may simply request feedback via an email response.
Although Pre-Sub meeting submissions are not mandatory, medical device and IVD manufacturers are highly encouraged to do so in order to receive early feedback and ensure better quality of their regulatory submissions to the FDA. If you opt to take advantage of the FDA Pre-Sub program, you must do so before initiating your 510(k) or premarket application (PMA) review process, or beginning a clinical study on which you are seeking feedback. The contents of your Pre-Sub submission should include a cover letter explaining the reason for your submission, a description of your medical device along with its proposed intended use, a thorough description of the device and its technology, your planned testing strategy, and specific questions on which you are requesting input from the FDA.
Pre-Sub Meeting Submission Consulting
Emergo can assist with Pre-Sub consulting for IDE applications, 510(k)s and other FDA submissions. Our services include:
- Pre-Sub submission to send to the FDA: This is essentially a dossier that includes details of the devices's design and intended use, the proposed study protocols, and the specific questions to the FDA.
- Pre-Sub meeting: This is the actual meeting with the FDA. Emergo can help you prepare for the meeting and guide the meeting discussion content to ensure optimal use of the one-hour meeting timeframe.
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.
Please contact us for more information on Pre-Sub consulting for medical devices.