Counsel to the companies building devices, diagnostics, and the software that runs them, in a field where the regulatory pathway, the intellectual-property estate, and the corporate structure all have to agree before a product becomes a business.
A 510(k) is cleared, not approved, and the difference is the whole business plan. Clearance rests on substantial equivalence to a predicate device already on the market, so the predicate is chosen before the company is, and a Class II device with one reaches market on a different clock and budget from a Class III device that needs a premarket approval with clinical data behind it.
The rest of the file carries dates too. Since February 2026 the FDA's quality system regulation has incorporated ISO 13485, so a quality manual written to the old rule is a diligence finding. A device-related death or serious injury must be reported within 30 calendar days. A laboratory-developed test sits under CLIA rather than FDA premarket review, a line the agency tried to redraw by rule in 2024 until a federal court vacated the rule in 2025.
We handle the corporate, financing, and transactional side of companies built on these facts, and coordinate with FDA regulatory counsel on submissions and registered patent counsel on prosecution, so the structure and the deal terms rest on the regulatory record rather than the pitch deck.
Advising on how a product is likely to be classified, which of the 510(k), De Novo, or PMA pathways it points toward, and how that posture shapes structure, diligence, and deal terms, with FDA regulatory counsel brought in for the submissions themselves.
Ownership, assignment, licensing, and diligence on the patents, trade secrets, and diagnostic data that are often a venture's principal asset. We handle the corporate and transactional side of that estate and coordinate with registered patent counsel on prosecution.
Seed, venture, and growth rounds and strategic investment for device and diagnostics companies, covering the term sheet, the financing documents, and the regulatory and IP diligence that has to clear before capital closes.
Acquisitions, licensing and distribution arrangements, joint ventures, and exits to larger device and diagnostics players, run so that the corporate, regulatory, and intellectual-property questions are answered together.
Distributor, laboratory, and health-system contracts and the commercial model around a cleared product, with coding, coverage, and claims constraints worked through alongside reimbursement advisers where coverage analysis is required.
Fraud-and-abuse and anti-kickback posture, advertising and claims limits, quality-system and clinical obligations in commercial terms, and the governance frameworks that keep a regulated product defensible as the business scales.
A product's class, I, II, or III, and its route, 510(k), De Novo, or PMA, set the timeline to market, the cost of diligence, and the risk a buyer underwrites. Both have to be mapped early.
Patent assignments are read for one verb. An agreement to assign conveys nothing until a second document is signed; a present assignment conveys the invention the day it is made. Diligence reads every founder and university chain for that word, then for the government's license and march-in rights in anything built on grant money.
The 21st Century Cures Act took several software functions out of the device definition: administrative tools, general wellness products, and clinical decision support whose recommendation a clinician can independently review. Hide the basis for the recommendation, or let the software drive the therapy itself, and the exemption is gone and the product needs a pathway.
A corporate acquirer opens the regulatory file before the model: the 510(k) summary and any FDA correspondence, the complaint and medical-device-report log, and the last inspection's Form 483 with the company's response. A warning letter stays on the FDA's public site after it is closed out, so the response matters as much as the finding.
A cleared product still needs a billing code, a coverage decision, and a payment rate, each from a different body. The AMA's CPT panel meets three times a year, Medicare coverage is set nationally or by regional contractors, and commercial payors decide for themselves. Launch plans are built on those dates, not the clearance letter.
A US clearance has no force in Europe. A CE mark under the EU Medical Device Regulation comes from a notified body, not a regulator, and the legacy-device transition now runs to the end of 2027 or 2028 by risk class. The European file is a second file, read in a second diligence.
Before the first institutional dollar, we map where the product sits: device class, likely pathway, and the regulatory status of the software itself. Then we build the entity, founder IP assignments, and cap table around that answer. A company formed before its predicate is identified is a company formed on a guess.
Financing a device venture means financing its patents, trade secrets, and clinical data. We clean ownership and assignment chains, frame freedom-to-operate posture with patent counsel, and negotiate term sheets in which regulatory milestones, rather than revenue, set the tranching logic.
While FDA regulatory counsel runs the submission, we build what clearance will land on: manufacturing and supply agreements, distributor and health-system contracts drafted inside anti-kickback and claims-substantiation limits, and a reimbursement thesis tested before launch.
Strategics buy medtech through the regulatory file. We keep the quality-system record, IP chain, and commercial contracts diligence-ready year-round, then run the sale or license so the acquirer underwrites a documented posture rather than a story about one.
A device company is valued the way it will be diligenced, so we build the file before anyone asks for it.
Hart David Carson LLP acts for the companies building hardware and diagnostic products: medical-device ventures, in-vitro and laboratory-developed diagnostics, imaging and wearable platforms, and the software-as-a-medical-device businesses at the line between device and digital health. We also advise the venture funds, strategics, and family offices that finance them. The common thread is a regulated product whose corporate structure, regulatory pathway, and intellectual property all have to line up before it can scale.
We advise on FDA strategy as part of structuring and financing the business: how a product is likely to be classified, which pathway it points toward, and how that posture shapes diligence, timelines, and deal terms. For the regulatory submissions themselves, the 510(k), De Novo, and PMA filings along with clinical and quality-system matters, we coordinate with FDA regulatory counsel and consultants where required, so the legal architecture and the filing strategy fit each other.
It sets the clock, the evidence, and the risk a buyer prices. A 510(k) is reviewed against a 90-day performance goal and rests on showing substantial equivalence to a predicate, often with bench data alone. A De Novo request for a novel device of low or moderate risk runs to a 150-day goal. A premarket approval runs to 180 days before any advisory panel and generally needs a clinical study of the company's own. In a deal that becomes milestone tranches tied to a decision date, representations about the accuracy and completeness of what was filed, and a special indemnity for the gap between the device that was cleared and the device that is being sold.
For a medtech or diagnostics venture, the IP estate is often the principal asset: the patents covering the device or assay, the trade secrets in a manufacturing process, the data behind a diagnostic claim, and the freedom to operate without infringing a crowded field. We handle the corporate and transactional side of that estate, from ownership and assignment to licensing and diligence, and coordinate with registered patent counsel on prosecution and patentability, so the rights that give the company its value are clean by the time an investor or acquirer looks at them.
Yes. A medtech round or sale differs from a software deal in what the diligence reads: the 510(k) or PMA file with the FDA's correspondence, the complaint and medical-device-report log, and the quality-system record, alongside the patent chain. A buyer also takes on the establishment registration, the device listing, and the post-market obligations that attach to a device already in the field, so the purchase agreement says who answers the next inspection. We run the financing or the sale with that file assembled before the data room opens, so the regulatory record supports the price rather than discounting it.
Yes, as part of building a durable commercial model. A cleared product still has to be paid for, sold, and distributed within the rules, which brings in coding and coverage, fraud-and-abuse and anti-kickback constraints, advertising and claims limits, and the contracts with distributors, labs, and health systems. We structure those commercial relationships and coordinate with reimbursement advisers where coding and coverage analysis is required, so the path from clearance to revenue is mapped in advance.
Counsel to therapeutics and biotech ventures and the investors behind them on corporate structure, licensing, financing, and the regulatory diligence that frames a deal.
Explore →Privacy, corporate-practice, and commercial structuring for telehealth, health-data, and digital-care platforms, the businesses delivering care through software.
Explore →Regulatory strategy across the life-sciences sector, covering classification, claims, and compliance frameworks, coordinated with FDA regulatory counsel where filings are required.
Explore →Reviewed by Jonathan D. Herpy, Sr., Senior Partner · Last updated October 2026 · Educational overview · Not legal advice
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