Should I Request A Q-Submission For My Medical Device - Med Device Online

By Caitlin Bancroft, JD, RAC, elder regulatory affairs specialist, Pharmatech Associates

For immoderate aesculapian instrumentality submission, the astir almighty root of accusation volition ever beryllium connection with the FDA. A mechanics is disposable to petition feedback: the Q-Submission¹ programme is the pathway for a instrumentality sponsor to scope retired to petition a gathering oregon written responses. Q-Submissions are designed to code circumstantial questions astir a product’s regulatory strategy oregon investigating plan, including bench, animal, and objective testing.

Gaining statement with the bureau earlier conducting costly and time-consuming tests avoids the delays and costs of rewriting a submission. Many sponsors person moved guardant with regulatory strategies assuming the FDA volition hold to their plan, lone to person a not substantially equivalent (NSE) determination oregon a denial of approval. This nonfiction outlines the reasons that a Q-Submission is astir ever worthy it and describes however to optimize the opportunity. We marque the lawsuit that the clip and wealth for a Q-Submission pales successful examination with what is needed to close investigating and regulatory strategies resulting from unexpected feedback astatine the clip of a selling authorization submission.

Medical Device Submissions: Request For Feedback And Meetings

Understanding the FDA’s sentiment is captious successful preparing to record a aesculapian instrumentality submission arsenic a means of seeking guidance that pertains to planned Premarket Notification (510(k)) submissions, Premarket Approval (PMA) applications, oregon Investigational Device Exemptions (IDE) applications, among galore others. Through a Q-Submission, a instrumentality sponsor whitethorn straight airs questions to the FDA concerning your product, testing, oregon regulatory strategy and person guidance successful response. Some communal types of Q-Submissions see Pre-Submissions, Submission Issue Requests, Study Risk Determinations, and Informational Meetings.

The Q-Submission allows you to stock accusation with the FDA and person input extracurricular of the ceremonial submission process. This is besides the constituent erstwhile the task manager (PM) is identified, assigned, and a narration begins, which is invaluable for sponsors. Through a Q-Submission, you whitethorn person guidance connected galore topics, including costly seat and carnal testing, objective trials, and regulatory strategy.

When To Request A Q-Submission

A Q-Submission is invaluable during immoderate constituent successful development, but it is astir adjuvant anterior to conducting the astir cost- and labor-intensive parts of merchandise improvement — bench, animal, and objective investigating — a Pre-Submission type. For people II devices, this investigating goes hand-in-hand with predicate selection, fixed that investigating plans are mostly developed based connected the investigating conducted connected the chosen predicate. If you scope retired to the bureau anterior to opening investigating and choosing a predicate, you tin summation clarity connected what benignant of expectations beryllium regarding collecting information for approval/clearance. However, adjacent if a merchandise has already gone done testing, determination is worth successful submitting a Pre-Submission. It gives you the accidental to contiguous information oregon conclusions that are hard to construe to the FDA anterior to afloat submission review.

Often, the FDA gives a sponsor a clasp missive owed to a deficiency of data. Q-Submissions taking spot aft receiving a clasp missive successful effect to a pending selling application, Submission Issue Requests (SIR), tin beryllium adjuvant to code circumstantial questions regarding reappraisal issues. An SIR is simply a mode to summation feedback connected the sponsor’s plans for further information postulation and confirmation that a bridging protocol addresses the agency’s concerns.

An Argument For Time Savings And Risk Tolerance

From a applicable perspective, a Q-Submission volition astir ever prevention you clip and wealth by ensuring cost- and labor-intensive improvement activities are undertaken with the FDA’s blessing. Unless a submission is for an identical instrumentality that a sponsor already has connected the market, determination volition beryllium questions surrounding what the investigating program should look like. When questions are raised with the FDA, clarity tin beryllium gained earlier the incorrect way is taken. Often the planned investigating volition beryllium excessively small oregon incorrect from the agency’s perspective. Learning that your projected biocompatibility implantation survey is excessively abbreviated earlier initiation saves you from conducting a 2nd one. Gaining statement connected your predicate anterior saves clip and wealth and increases the likelihood of a palmy submission avoiding the request to re-submit aft receiving a clasp letter. Lastly, unfastened connection with the bureau gives them a preview into your merchandise and what they tin expect from your submission. This whitethorn pb to a quicker submission reappraisal time.

You whitethorn beryllium acrophobic that going done the Q-Submission process is an other measurement that slows clip to market. It is an understandable concern, but 1 that is rooted successful the presumption that the planned regulatory and investigating strategy is wholly close — a level of assurance that is often misplaced. Different products ever rise antithetic issues and antithetic reviewers whitethorn spot chiseled problems that had not antecedently been considered. The clip needed for a Q-Submission is mostly little than the clip required to repetition investigating oregon code issues arising during the review.

Occasionally, companies are acrophobic astir a Q-Submission due to the fact that they don’t privation to “tip their hand” to FDA and person labor/time-intensive feedback that whitethorn not person arisen during the submission reappraisal process. In practice, this does not happen. Agency reviewers are arsenic adept astatine spotting imaginable issues successful a submission arsenic the sponsor. The questions not asked during a Q-Submission volition astir apt travel up during submission review. A sponsor is walking connected a precocious ligament if they are operating based connected the anticipation the FDA volition not announcement the concerns they person astir their submission.  

Ultimately, it is simply a question of hazard tolerance. Companies should comparison the cost/time of a Q-Submission with the imaginable cost/time of proceeding with a strategy that whitethorn beryllium unsuccessful with FDA. A Q-Submission is the much cautious attack and volition apt effect successful a faster clip to marketplace owed to a targeted merchandise improvement process and a quicker submission reappraisal time. However, if the shortest clip to marketplace is paramount, a sponsor whitethorn determine that the emblematic 60 to 90 days needed for a Q-Submission is excessively precocious a cost.

How to Increase The Value of A Q-Submission Meeting

Once you person decided to taxable a Q-Submission, determination are respective ways to maximize the opportunity:

1. Ask astir the areas of top concern. The FDA recommends that a constricted fig of questions and subjects beryllium addressed successful each Q-Submission to guarantee broad answers. By looking astatine the programme successful its entirety, you volition beryllium capable to accurately place the areas wherever you request FDA guidance.
2. Carefully trade questions to advocator for your position. Questions that statesman “please confirm” oregon “do you agree” suggest a prospective reply and enactment the bureau successful a spot to hold with your proposal. In spite of the “least burdensome”² provisions, FDA volition instrumentality a reasonably expansive presumption of investigating and regulatory requirements. Leading them to the reply you privation is beneficial.
3. Be alert of what the bureau volition and volition not review. You should reappraisal what the Q-Submission guidance says astir the benignant of gathering requested to corroborate the questions included are appropriate.
4. Consider whether to bash a gathering oregon person written responses only. There are benefits to a meeting: on-the-spot and unfiltered guidance, a accidental to respond to questions successful existent clip and recognize the FDA’s thought process. However, determination tin beryllium drawbacks. Not each personalities are suited for a speech with the FDA. It is indispensable that radical who thin to beryllium antiaircraft oregon aggressively argumentative not beryllium included. FDA volition disagree with immoderate of a sponsor’s proposals. While gathering attendees tin and should advocator for the organization’s position, it is important that guidance and denials beryllium received good during the meeting. Written responses let for FDA to trade their answers intentionally and debar immoderate unproductive confrontations.

Is A Q-Submission Worth It?

From a applicable perspective, a Q-Submission is astir ever worthy it. The extremity of immoderate sponsor is to get to marketplace arsenic rapidly and cost-efficiently arsenic possible. Going done the Q-Submission process allows you to summation FDA penetration and provides a preview of a coming submission that volition pb to quicker reappraisal times and less post-submission requests for information. By thoughtfully considering topics to sermon and crafting questions carefully, you volition find a Q-Submission to beryllium a invaluable and powerfully informative endeavor.

References

1. U.S. Food and Drug Administration. Center for Devices and Radiological Health. (2021). Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. https://www.fda.gov/media/114034/download
2. U.S. Food and Drug Administration. Center for Devices and Radiological Health, Center for Biologics Evaluation and Research. (2019). The Least Burdensome Provisions: Concept and Principles. https://www.fda.gov/media/73188/download

About The Author:

Caitlin Bancroft, JD, is simply a elder regulatory affairs specializer with Pharmatech Associates – a USP company. Her expertise is successful regulatory compliance of aesculapian devices, spanning 510(k), PMA, De Novo, Modification, Reclassification, IDE, and the EU Medical Device Regulation. Her enactment includes the reappraisal and exertion of FDA and EU regulations concerning prime absorption systems, existent good manufacturing practices, objective evidence/trials, ailment handling, hazard management, and selling authorization requirements.