The FDA encourages sponsors of clinical trials testing medical devices to communicate openly with the Agency. Although currently available to be used for other types of submissions, the Q-Submission Program, which replaced the pre-IDE program in 2017, was originally designed to provide mechanisms for investigators to request feedback from, or a meeting with, the Food and Drug Administration regarding potential or planned medical devices. It continues to support the following types of medical device submissions:
Investigational Device Exemption (IDE) Applications,
Premarket Approval (PMA) Applications,
Humanitarian Device Exemptions (HDE) Applications,
Evaluation of Automatic Class III Designations (De Novo requests),
Premarket Notification (510(k)) Submissions,
Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications (CW),
Dual 510(k) and CLIA Waiver by Application Submissions (Duals),
Accessory Classification Requests, and
Certain Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs) submitted to the Center for Biologics Evaluation and Research (CBER).
By communicating with FDA throughout a submission process, information can be exchanged in a more expeditious manner thus reducing the review cycle turn-around time. FDA provides advice to sponsors through the Q-Submission or Q-Sub program. A Q-Sub request must include one electronic copy (eCopy) in the English language. For information regarding eCopy, refer to the Initial IDE submission ReGARDD webpage.
For more information about the Q-submission process or any of the specific Q-Subs described below, including content requirements, please see FDA's Guidance entitled "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program" .
Informational meetings are appropriate when a sponsor wants to share information with FDA without an expectation of feedback. FDA will be in a listening mode. This meeting type is appropriate when a sponsor wants to provide an overview of ongoing device development when there are multiple submissions planned within the year. This is also useful to familiarize the FDA review team with a new device that has significant technological differences from current devices and to educate the reviewers on advancements they will be seeing in the future.
Agreement Meetings are available to any sponsor planning to investigate the safety or effectiveness of a class III product or any implant. The Agreement Meeting is available to submitters of 510(k)s for eligible devices as well. The purpose of this meeting is to reach agreement on the key parameters of the investigational plan (see 21 CFR 812.25 ), including the clinical protocol. The meeting is to be held within 30 days of FDA receipt of the request. Any agreement reached in this meeting is also to be written, shared with the applicant, and made part of the administrative record. It is binding on the FDA and may be changed only with the written agreement of the applicant or when there is a substantial scientific issue essential to determining the safety or effectiveness of the device.
A Determination Meeting, is available to anyone anticipating submitting a PMA or Product Development Protocol (PDP) and is intended to provide the applicant with the Agency's determination of the type of valid scientific evidence that will be necessary to demonstrate that the device is effective for its intended use. This type meeting will result in FDA's conclusion whether clinical studies are needed to establish effectiveness and, in consultation with the applicant, determine the least burdensome way of evaluating device effectiveness that has a reasonable likelihood of success. The applicant can expect that FDA will determine if concurrent randomized or non-randomized controls, historical controls, or other types of evidence will be acceptable. FDA's determination is to be written, shared with the applicant within 30 days following the meeting, and is binding upon the Agency, unless it would be contrary to public health.
It is important to note the Agreement and Determination Meetings are intended for those studies for which the endpoint is pre-determined to be commercial product marketing approval from FDA. Additionally, both type meetings require a formal letter and meeting to be effectively utilized. For additional information regarding Agreement and Determination Meetings, please see FDA's Guidance on Early Collaboration Meetings Under the FDA Modernization Act (FDAMA) .
Day 100 Meeting
A PMA applicant may request a Day 100 Meeting to discuss the review status of their PMA. FDA will inform the applicant of any identified deficiencies prior to the meeting, which will take place no later than 100 days after the receipt of the PMA application. FDA recommends that a request for a Day 100 Meeting be submitted with the original PMA or as a Q-Submission (Q-Sub Day 100 Meeting Request) no later than 70 days from the PMA filing date so that FDA has sufficient time to schedule the meeting. This meeting may be used to discuss identified issues and remedial actions, an action plan with estimated dates of completion, FDA estimated timetables for review completion, the need for panel involvement, or possible premarket versus post market requirements.
Defined as a formal written request for Agency feedback, the Pre-Submission or Pre-Sub is not a required submission nor is the response received binding on the part of the FDA. A sponsor is encouraged to request a Pre-Sub when FDA's feedback on specific questions is necessary to guide product development and/or application preparation. A Pre-Sub may be submitted in advance of an IDE or marketing application, and importantly, a Pre-Sub may also be submitted for a clinical study for which an IDE would not be required, (e.g., NSR device studies, IDE exempt device studies, or for studies conducted entirely outside the USA (OUS)). The Pre-Sub should include a request for an in-person meeting, teleconference, or written responses to specific questions regarding the IDE submission and/or study protocol associated with the device. For all Pre-Submissions in which a meeting or teleconference is being requested, a minimum of three proposed meeting dates should be provided in the initial submission. Within 15 calendar days, FDA will either confirm one of the dates or provide two alternative dates prior to calendar day 75 from the receipt of the accepted submission. FDA will provide written feedback with responses to the sponsor's questions for all Pre-Subs, regardless of whether the sponsor requested a meeting, teleconference, or written feedback.
Study Risk Determination
FDA will review a study protocol and issue a letter to the sponsor indicating if the study is exempt, or if not exempt, whether the study is significant risk or non-significant risk. This letter may be submitted to Institutional Review Boards (IRBs) who then do not need to conduct their own independent assessment of the study risk because FDA's determination is final. Please note that a study risk determination does not obligate the sponsor to submit a future IDE application. For additional information regarding Study Risk Determinations, please visit the ReGARDD Study Risk Determinations from FDA page or refer to the FDA Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors – Significant Risk and Nonsignificant Risk Medical Device Studies .
Submission Issue Request (SIR)
A sponsor may request this type meeting to discuss deficiencies identified during FDA's review of an application. The purpose of the meeting is to request FDA feedback on a proposed approach to address issues conveyed in a marketing submission hold letter, CW hold letter, or an IDE Letter. The SIR is intended to facilitate interaction between FDA and the sponsor/investigator to quickly resolve or clarify issues identified that are associated with a request for additional information regarding a 510(k), De Novo request, and CWs, major deficiencies resulting in not approvable, approvable with deficiencies, approvable pending GMP, or Approval with PAS conditions for PMAs and HDEs. This may be addressed in a submission issue meeting or teleconference. This is not necessary for simple requests for clarification of issues in a letter that does not require the involvement of management or to discuss issues while a file is under active review. This process is also not appropriate for discussing letters conveying FDA's final decisions, such as Not Substantially Equivalent, Withdrawals, or Deletions. If a Submission Issue Request is received within 30 days of FDA's marketing submission hold, IND Clinical Hold letter, or IDE letter, the FDA team will aim to provide feedback within 21 days, as resources permit. This is referred to as a Submission Issue Request A. If a Submission Issue Request is submitted more than 30 days after FDA's letter, FDA will aim to provide feedback within 70 days, as resources permit. This is referred to as a Submission Issue Request B.
Breakthrough Device submissions
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is available for device products which are subject to FDA review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo request.
For devices designated as a Breakthrough Device, FDA intends to provide interactive and timely communication with the sponsor during device development. FDA will issue a grant or denial decision for each Breakthrough Device designation request within 60 calendar days of receiving such a request. Given this limited timeframe, a sponsor should be available and responsive to agency requests for information during this period.
There is an extensive discussion of the program's features and the criteria to be met for this designation in the agency's guidance Breakthrough Devices Program .
Safer Technologies Program for Medical Devices (STeP) submissions
The STeP program is a voluntary program for medical devices that don't meet the criteria to be designated a Breakthrough Device. These are medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities that are less serious than those eligible for the Breakthrough Devices Program.
FDA has modeled STeP on the principles and features of the Breakthrough Devices Program and is available to device products which are subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo request.
There is an extensive discussion of the program's features and the criteria to be met for inclusion in this program in the agency's guidance Safer Technologies Program for Medical Devices .
Accessory Classification Requests
The concept of a device accessory ("accessory") is one of a finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices. The classification of accessories is subject to the same risk- and regulatory control-based scheme that FDA uses to classify all medical devices. The risks of an accessory are the risks that it presents when used as intended with the corresponding parent device.
The classification or reclassification of a legally-marketed accessory (existing accessory type) or a new accessory (new accessory type) can be requested using the Q-Submission process. The timelines for (re)classification differ depending whether the device is an existing or new accessory type. The classification policy, process, definitions, and timelines are described in the agency's guidance Medical Device Accessories – Describing Accessories and Classification Pathways .
The different types of Q-Subs along with the method and timeline for feedback for each Q-Sub type are listed in the table below:
|Q-SUB TYPE||METHOD OF FEEDBACK||TIMELINE FOR FEEDBACK
(from receipt of submission)
|Pre-Submission||Written||70 days or 5 days prior to a scheduled meeting, whichever comes sooner|
|Meeting upon request||Meeting date based on mutual agreement (typically at 60-75 days)|
|Informational Meeting||Meeting||90 days|
|Study Risk Determination||Formal Letter||90 days|
|Agreement Meeting||Meeting and Formal Letter||30 days or within time frame agreed upon with applicant|
|Determination Meeting||Meeting and Formal Letter||Date of meeting agreed upon within 30 days of Request|
|Submission Issue Request (SIR)||Meeting and Formal Letter||No acceptance review|
Submission Issue Request A: 21 days
Submission Issue Request B: 70 days
|Day 100 Meeting||Meeting||100 days (from PMA filing date)|
|Breakthrough Designation Request||Formal Letter||60 days from reciept of request|
|STeP: Request for Inclusion||Formal Letter||60 days from reciept of request|
|Accessory Classification Requests||Existing Accessory||85 days from receipt of request|
|New Accessory||FDA must grant or deny the New Accessory Request concurrently with the decision on the (device) premarket submission with which the request was submitted|