Regulatory counsel for products the FDA touches, covering classification, premarket pathways, labeling and promotion, and enforcement strategy, and moving with the deal and the science rather than against them.
A product's intended use is read from its labeling, its advertising and the circumstances of its sale, not from what the engineers meant, and that reading decides whether it is a device, a drug or neither. A Form 483 closes an inspection, and a response filed within fifteen business days is considered before the agency decides whether a warning letter follows. A dietary supplement may make a structure-or-function claim, but the company must notify the FDA within thirty days of marketing it with the claim and carry the disclaimer. Each is a rule a general counsel can hold the business to; each is routinely missed.
We advise healthcare, biotech and longevity ventures on the legal architecture of an FDA-regulated product and on what it commits the company to after launch. Regulatory affairs consultants author the technical file; we decide what the company may say about it, and we carry the regulatory read into the financing or the sale, where it sets the price.
Determining where a product falls among the drug, device, biologic, combination product, cosmetic, and dietary supplement categories, the threshold question that decides the pathway, the permissible claims, and the obligations that follow.
Advising on the legal and strategic dimensions of 510(k), De Novo, PMA, IND, NDA, and BLA routes, including how a submission is positioned and what it commits the company to, coordinated with regulatory affairs consultants where authorship is required.
Reviewing labeling, advertising, and promotional materials against a product's regulatory status and substantiation, so the marketing message and the clearance match and exposure does not build silently.
Counsel on quality-system, adverse-event reporting, and post-market surveillance obligations, the duties that continue after launch and that an acquirer or regulator will examine closely.
Representation in matters before the FDA, including warning letters, Form 483 inspection observations, import detentions, and recall decisions, framing a credible response and coordinating remediation with technical and quality teams.
Bringing the regulatory read into acquisitions, licensing, and financings by sizing classification and enforcement risk, shaping representations and warranties, and structuring the deal around what the regulatory posture will support.
Devices fall into three classes. Most Class I and some Class II are exempt from premarket notification; the rest of Class II clear by 510(k) against a predicate; Class III needs premarket approval. A novel device without a predicate is not automatically Class III: De Novo can classify it down.
A 510(k) clearance belongs to its holder and moves with an asset purchase, but the establishment registration, the device listing and the quality system do not move; the buyer re-establishes each within set windows. Diligence traces the clearance, its predicates and every change made since without a new submission.
Promotion claiming a use outside the cleared or approved labeling makes the product misbranded, and the question is intended use, not whether the claim is true. The FTC asks instead whether a health claim rests on competent and reliable scientific evidence. One sentence on a website can fail both tests.
A device maker reports a death or serious injury to the FDA within 30 calendar days of learning of it, and a correction or removal undertaken to reduce a health risk within ten working days. Since February 2026 the quality system rules have been rebuilt on ISO 13485.
A pre-submission meeting is the chance to hear the review division's view before the company commits to a predicate, a clinical endpoint or a sample size, and the agency aims to answer within 70 days. Regulatory affairs consultants write the technical file; we decide what the company commits to by filing it.
In 2023 the agency moved research peptides into the category compounders may not use, and when it declared the semaglutide shortage over in 2025, pharmacies had 60 days to stop and outsourcing facilities 90. A longevity clinic's supply chain is a regulatory position with an expiry date.
Before anything is filed, we answer the threshold question in writing: device, drug, biologic, combination product, or something the agency has not yet named. The intended-use statement is drafted here, and it quietly decides the pathway, the claims, and the cost of everything after.
With the classification fixed, the route is chosen from 510(k) predicate strategy, De Novo, PMA, or an IND opening a clinical program, and it is tested against the agency through a pre-submission meeting before the company commits. Regulatory consultants author the technical file; we hold the legal position it must not outrun.
While the submission sits in review, we draw the perimeter the product will live inside: labeling, promotion, and website copy audited against the clearance being sought, so day-one marketing does not exceed what the agency actually granted.
After clearance, the obligations begin: quality systems, adverse-event reporting, and 483 and warning-letter response. The regulatory file becomes the diligence asset an acquirer or Series B lead will read line by line, and we keep it in a condition worth reading.
The intended-use sentence is the most expensive sentence the company will ever write.
FDA regulatory counsel is the legal work of bringing a healthcare product to market and keeping it there: determining how a product is classified, which premarket pathway applies, what the labeling and promotion may claim, and what quality and post-market obligations attach once it is sold. We advise on these questions for healthcare, biotech, medtech, and longevity ventures, and coordinate with regulatory affairs consultants where a matter calls for them.
We start with classification, because almost everything that follows depends on it. A product's status as a drug, device, biologic, combination product, cosmetic, or dietary supplement determines the pathway, the claims, and the obligations. From there we map the regulatory strategy onto the company's commercial and corporate plan, so the path to market and the deal or financing behind it move together rather than at odds.
We advise on the pathway and on what the submission commits the company to; the technical file itself is written by regulatory affairs consultants we work alongside. For a device the choice runs from a 510(k) against a predicate to De Novo for a novel low-to-moderate-risk product to a premarket approval for Class III. For a drug or biologic it runs from the investigational new drug application that opens a clinical program to the new drug or biologics license application at the end of it, with designations such as orphan, fast track and breakthrough adjusting the timeline and the exclusivity along the way. Each path has a pre-submission step where the agency's view can be heard before the company commits, and each has a price in time, evidence and post-market duties. Our work is to make sure the legal position, the intended-use statement and the commercial plan all describe the same product, because a submission that outruns the marketing plan, or a marketing plan that outruns the submission, is the failure mode we see most.
Yes. Labeling and promotion are where regulatory exposure most often surfaces, because a claim that outruns the product's clearance or substantiation can invite a warning letter, a recall, or litigation. We review labeling, advertising, and promotional materials against the product's regulatory status, advise on substantiation, and help structure marketing so the message and the clearance match.
The clock starts when the investigator hands over the Form 483 at the close of the inspection. A written response within fifteen business days is considered by the agency before it decides whether to issue a warning letter, so that fortnight is spent documenting corrections already made, committing to dated ones and disputing observations that are wrong, with evidence attached. A warning letter asks for a response within fifteen working days as well, is published, and is read by every customer, investor and acquirer until the agency issues a close-out letter, which it does only after it has verified the corrections. We represent clients in matters before the FDA at each of those stages, coordinate the remediation with the quality and technical teams and manage the record so that a single inspection does not become a consent decree.
In life sciences, the regulatory file is often the asset. Diligence in an acquisition, licensing deal, or financing turns on classification, the strength of the premarket position, the labeling claims, and any open enforcement exposure. We bring the regulatory read into the transaction by sizing the risk, shaping the representations and warranties, and structuring the deal around what the regulatory posture will and will not support.
Corporate, licensing, and regulatory strategy for therapeutics companies and the investors backing them, from research collaborations to the path through clinical development and commercialization.
Explore →Deal structure, IP, and regulatory posture for device and diagnostics ventures, where product classification and the premarket pathway shape the value of the company.
Explore →Counsel for software, platforms, and connected-care ventures where healthcare meets technology, on data, regulatory status, and the transactions that scale them.
Explore →Reviewed by Jonathan D. Herpy, Sr., Senior Partner · Last updated October 2026 · Educational overview · Not legal advice
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