Know your pathway. Prepare for what FDA needs next.
Regulatory Strategy & FDA Support
Every regulatory decision carries through design, testing, manufacturing and commercialization. Mittal Consulting builds strategy that aligns regulatory, reimbursement and clinical planning from the start, so each decision supports the next.
Regulatory Services
In-Depth Strategy
Regulatory decisions carry through every stage of a device program, from design and testing to manufacturing and commercialization. Mittal Consulting builds strategy that aligns regulatory, reimbursement and clinical planning from the start, so each decision supports the next. Clinical expertise comes from affiliate consultants, brought in and coordinated internally so the client keeps one point of contact throughout. As an extension of the client's team, Mittal Consulting sets regular touchpoints matched to where the client is in their journey, increasing around submissions and continuing between them.
Regulatory Strategy Report (RSR)
Each Regulatory Strategy Report opens with a kickoff meeting, and our expert team arrives having already studied the device description, prior testing and known competitors, with detailed questions on the device's novelty, its clinical context and how the existing work measures against what the next regulatory step requires. That meeting confirms our understanding and explores the company's business goals and how the strategy can support them. The analysis looks for where the device can stand apart, across the regulatory and competitive landscape, product codes, classification, each viable pathway, proposed claims and reimbursement. A mid-point check-in shares preliminary findings, resolves open questions and gives the client room to add questions for assessment. At six weeks, the final report and debrief deliver full findings and key action items, structured for board and investor conversations. For many clients, it becomes the foundation for the regulatory roadmap and a lasting partnership with Mittal Consulting.
Pre-Submission (Q-Sub)
Mittal Consulting builds each Pre-Submission around questions designed to draw FDA feedback that informs testing, clinical and capital decisions. Kickoff sets goals around the device and its existing regulatory strategy, such as detailed feedback on clinical study design or de-risking animal testing ahead of an IDE. Drafting is collaborative, with working sessions weekly or every other week based on client priorities, and our team submits to FDA on the client's behalf. We invest deeply in meeting preparation so every interaction is used strategically, drawing on direct agency experience to read what FDA's written feedback signals and where FDA needs a clearer understanding of the device or more confidence in it. Our team shapes the agenda with the client, leads rehearsals and manages the dialogue with FDA. Afterward, we draft and submit the minutes and lead a debrief on FDA's positions, open questions and next steps. Clients move forward with a precise FDA record and clear direction for every decision that follows.
De Novo
How a novel device is characterized influences the classification FDA establishes and the standard others in its category will follow. Each De Novo engagement is built on a thorough understanding of the device's function, novelty, and clinical context. That understanding guides how risks are presented and how the proposed special controls are framed. The innovator enters the market having helped set the standard every competitor must meet, a position of market leadership investors recognize.
Breakthrough Designation
The value of Breakthrough Designation extends across regulatory, clinical, and reimbursement strategy. Mittal Consulting develops each request from a detailed assessment of the device and the clinical need it addresses. Once designation is granted, our team integrates it into program planning, including evaluation of Medicare coverage through TCET. The result is sustained engagement with FDA during development and external validation that strengthens the company's position with investors.
IDE
Every IDE our expert team builds starts from the evidence FDA will expect at final review, informed by in-depth knowledge of the device and current agency thinking. The team aligns clinical, quality and engineering on the protocol, risk analysis and device description, and works with clients to ensure all necessary pre-clinical testing is considered and included before the application reaches FDA.
PMA (Class III)
Mittal Consulting challenges the historical precedent that places many novel technologies on a PMA pathway by default, with a creative yet compliant approach, examining whether a device's technology, risk profile, and intended use can support a Class II route. Every pathway recommendation draws on Mittal Consulting's deep understanding of the technology and of FDA.
FDA Representation
A single FDA meeting can shape the future of a technology and the company behind it. Our team prepares for each meeting with exceptional depth, drawing on detailed knowledge of the device and close attention to evolving FDA policy and guidance, so every interaction is used strategically. Clients enter the meeting fully aligned with the team on objectives and positions. Afterward, Mittal Consulting drafts and refines the minutes with the client, submits them on the client's behalf and leads a debrief on where FDA concurred, where it maintained its position and what comes next. Clients gain a clear agency record and a partner with in-depth knowledge of the device, its regulatory history, and current FDA expectations.
Embedded Support
Mittal Consulting works as an extension of your team, keeping regulatory strategy connected from the C-suite to every function of your company and to the outside partners your device depends on. Clear communication keeps every test, document and decision aligned with that strategy, so each piece of work moves your device forward. Every client is supported by a dedicated Mittal Consulting lead and supporting staff, working alongside your team to keep workstreams organized, dependencies visible and every function clear on what the next regulatory step requires. Leadership gains a clear view of where things stand, and each team gets the direction it needs to keep work moving. When specialized expertise is needed, affiliate consultants are brought in and managed by Mittal Consulting, giving your team one central point of contact.
Regulatory Strategy FAQ
Can a medical device expected to require a PMA qualify for a De Novo or 510(k) pathway?
Yes. There is rarely one regulatory strategy for a novel device, and Mittal Consulting examines whether your technology, risk profile, and intended use could support each viable route, including a De Novo or 510(k) where the evidence allows. The approach is compliant but creative, and any alternative pathway is pursued with FDA alignment before your work builds on it.
What does an FDA Regulatory Strategy Report give our leadership team and investors?
Your Regulatory Strategy Report starts with understanding your device itself: its novelty, its function, the clinical need it meets, and where it fits in the clinical workflow. From there, it lays out the regulatory landscape, classification, viable pathways, and proposed claims, with reimbursement considered alongside. A debrief walks your team through the findings, and key action items are framed for board and investor conversations.
How do you build an FDA Pre-Submission (Q-Sub) that moves a medical device forward?
Every question in your Pre-Submission is shaped around the decisions your device depends on, so FDA’s feedback answers what matters most to your path. The submission is developed in close collaboration with your team and tells a consistent regulatory story, grounded in your device’s clinical picture. When specialized input strengthens the package, affiliate consultants provide additional expert review before it goes to FDA.
How do you prepare for and lead FDA meetings for medical device companies?
Preparation for every Pre-Submission and FDA meeting is extensive, so each interaction is used strategically. Mittal Consulting leads the dialogue at your side, drafts the meeting minutes, refines them with you, and submits them on your behalf. A debrief follows, outlining where FDA agreed, where it held its position, what questions remain, and what comes next.
Tell the right regulatory story for your device.
Give FDA a clear, compelling case, rooted in your device's clinical picture and built on the pathway that truly fits it.