FDA strategy and filings
A team with experience across FDA review, Medicare coding and product launch.
You do not need to know whether your product is a medical device before you contact us.
Fixed quote
Get a quote in 24 hours.
Tell us about your product and technology, and the questions or challenges you are facing around regulation. Within 24 hours you get a written scope and a fixed fee.
Whether you want to establish your product as a medical device or support a non-device position, we assess the intended use, claims and regulatory basis.
A simplified pathway overview, based on FDA’s pathway descriptions. Classification, intended use and applicable requirements determine the route.
Assess device status, then explore the applicable route.
Intended use + claims
Document the basis
Classify the device: Class I, II or III
Confirm the device’s classification and any exemption limits. Assess applicable enforcement-discretion policies separately. Other requirements may still apply.
Most Class I and some Class II devices are exempt from 510(k) submission, subject to the applicable exemption limits. Confirm the product code and classification regulation. Exemption from 510(k) does not remove other applicable requirements.
Begin with Regulatory Foundation · quote in 24 hoursUsually used for Class II devices, and for some non-exempt Class I devices. Assess substantial equivalence to a legally marketed predicate. The comparison depends on intended use, technological characteristics and the evidence supporting the device.
Begin with Regulatory Foundation · quote in 24 hoursInvestigate the De Novo route to establish Class I or II classification for novel low-to-moderate-risk devices without a suitable legally marketed predicate. Risk classification and the proposed controls shape the evidence plan.
Begin with Regulatory Foundation · quote in 24 hoursAssess the premarket approval requirements for a Class III device. The safety and effectiveness evidence required for a PMA should be planned around the applicable device requirements.
Begin with Regulatory Foundation · quote in 24 hoursAssess whether the product falls outside FDA’s device definition based on its intended use, claims and functions, and document the basis. Other regulatory requirements may still apply.
Begin with Regulatory Foundation · quote in 24 hoursSelect an offering to see its scope.
5 offerings
Regulatory Foundation
You receive a written recommendation on device status and the FDA pathway to investigate, with a Pre-Submission plan if needed. We assess intended use, applicable classification, guidance and public precedent to establish the basis for the work that follows.
Pre-Submission Preparation
You receive a Q-Submission / Pre-Submission briefing package built around the agreed questions for FDA. Meeting participation, client revision rounds and follow-up deliverables are specified in writing before work starts.
Submission Preparation
You receive an authored 510(k) or De Novo submission, or an independent review of your draft identifying likely FDA questions. Pathway, device complexity, evidence completeness and response support set the fixed quote. PMA programs are scoped separately.
Breakthrough Device Designation
You receive a Breakthrough Device Designation eligibility assessment and the agreed supporting rationale and request package. Designation work is separate from the marketing submission. Response support is set out in the quote.
Fractional Regulatory Lead
Strategic direction and ongoing oversight across product development, regulatory activities, quality systems, FDA interactions and commercialization readiness. Scope can include quality-system setup, the design history file and SOPs where applicable. Monthly, with a three-month minimum; major submissions are scoped separately.
Something else?
A readiness gap check before you file, Pre-Submission strategy, a quality system on its own, or a question that does not fit a package. Describe it and you get a fixed quote within 24 hours.
Every engagement is a fixed fee: no hourly billing. FDA fees, testing, clinical studies and other third-party costs are separate.
Why McCarthy Regulatory
We use FDA classification records, prior submissions and source documents to identify relevant precedents, clarify evidence gaps and recommend the next step for your product.
Look across product codes and prior submissions for devices that address a comparable use.
Review the available source documents for intended use, technology, evidence and the differences that could change your pathway.
Turn the comparison into a pathway recommendation, evidence gaps and questions to bring to FDA.
The team
The team behind McCarthy Regulatory brings experience with FDA submissions and with Medicare coding, coverage and payment, so each recommendation accounts for both.
Managing Director
FDA. Helped take multiple products through FDA, including Breakthrough Device Designation.
Reimbursement. Helped create InTandem’s new Medicare code; chaired the Digital Therapeutics Alliance board.
Regulatory and quality leader with experience spanning diagnostics, therapeutic medical devices, software-based technologies, and clinical development.
Experience at Abbott, Baxter and MedRhythms.
FDA + Medicare, together
When reimbursement is part of your product’s plan, coordinate the intended use, claims and evidence plan around the questions that matter for both FDA and reimbursement.
Ask for one quote covering both practices, from the first pathway screen on each side to a combined strategy.
McCarthy Regulatory
Which FDA pathway fits the product
with McCarthy Market Access
Which Medicare coding, coverage and payment route fits
One fixed quote for both, within 24 hours
Explore McCarthy Market AccessTell us about your product and technology, and the questions or challenges you are facing around regulation. We will send a written scope and fixed fee within 24 hours.
Include any existing pathway analysis or FDA correspondence in the conversation.
