Freedom to Operate
A 510(k) clearance, granted De Novo request or premarket approval is a significant milestone, and it is natural to treat it as the point after which a U.S. launch may proceed. From a patent perspective, it is not. FDA marketing authorization and freedom to operate answer different questions, are decided by different bodies and run on different clocks. Sequencing the two deliberately is one of the more consequential planning decisions a device company makes. What follows is general information, not advice about any particular product.
Each device pathway addresses safety and effectiveness. FDA describes a 510(k) as a premarket submission demonstrating that a device is as safe and effective as, that is, substantially equivalent to, a legally marketed device. The De Novo pathway classifies novel devices for which general controls, or general and special controls, provide reasonable assurance of safety and effectiveness but for which there is no legally marketed predicate. Premarket approval is FDA's scientific and regulatory review of the safety and effectiveness of Class III devices.
None of these pathways examines whether the device practices a third party's patent claims. A predicate device may itself be patented, and substantial equivalence to it implies nothing about a license. Under 35 U.S.C. §271(a), whoever without authority makes, uses, offers to sell, sells or imports a patented invention in the United States during the patent term infringes the patent. A marketing authorization is not authority from the patent owner.
A freedom-to-operate review asks whether a defined product, as it will be made, imported and sold in a defined jurisdiction, is likely to fall within unexpired patent claims in force there. It typically involves searching issued patents and published applications, identifying claims of potential concern, construing those claims, comparing them with the product and, where warranted, assessing validity or design-around options. Its output is a considered legal opinion, not a certification.
An FTO opinion speaks as of a date and about a specific design, and several features of the patent system limit how long that snapshot remains accurate.
U.S. applications are generally kept in confidence and published promptly after 18 months from the earliest filing date for which benefit is sought, under 35 U.S.C. §122, so a search conducted today cannot see most applications filed in the preceding year and a half, and applications filed with a nonpublication request may not be visible until they issue. Published applications can issue with claims different from those originally filed. A patent owner may keep a family open through continuation applications, which under 35 U.S.C. §120 can claim the benefit of an earlier filing date if filed before the parent is patented or abandoned, and which may be prosecuted with a competitor's product in view. Because patent term generally ends 20 years from the filing date under 35 U.S.C. §154(a)(2), a family filed years before launch may still be producing new claims afterward.
FTO is therefore better treated as a process with checkpoints than as a single event, and an opinion is worth revisiting when the design or the patent landscape changes materially.
FDA's Quality Management System Regulation (QMSR), effective February 2, 2026, incorporates ISO 13485:2016 by reference, including its design and development requirements, while retaining FDA-specific requirements, so harmonization with ISO 13485 is not the same as identity. Under that framework, a change after verification and validation generally has to be evaluated and documented, and a change to a cleared device may require its own regulatory analysis.
That structure suggests a sequence. An early landscape review during concept and feasibility can flag crowded areas while architecture choices remain open. A focused FTO review before design freeze allows claim-driven changes to be absorbed into ordinary development. Updates before submission and again before launch address newly published applications and newly issued continuations. The right timing depends on the product and the landscape, but the cost of acting on the results tends to rise at each stage.
A design-around is an engineering and regulatory decision as much as a legal one. Before freeze, it may be a component substitution. After clearance, the same change may call for new bench testing, possibly new clinical data, an assessment of whether a new submission is needed, and requalification of suppliers. Alternatives such as a license, a validity challenge or acceptance of a defined risk each carry their own cost. An FTO review performed early keeps all of those options available; one performed late may leave only the more expensive ones.
Section 271(e)(1) of the Patent Act provides that it is not an act of infringement to make, use, offer to sell, sell or import a patented invention solely for uses reasonably related to the development and submission of information under a federal law regulating the manufacture, use or sale of drugs. In Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990), the Supreme Court held that the provision extends to medical devices regulated under the Federal Food, Drug, and Cosmetic Act. In Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005), a drug case, the Court held that the provision can reach preclinical research where there is a reasonable basis to believe the work could produce information appropriate for an FDA submission.
In Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., 96 F.4th 1347 (Fed. Cir. 2024), a divided Federal Circuit panel held that the safe harbor is available for acts that bear a reasonable relation to the development and submission of information to FDA, and that the accused infringer's intent or additional purposes do not defeat it. Judge Lourie dissented, and the Supreme Court denied certiorari on January 13, 2025.
The safe harbor remains tied to the regulatory process rather than to the market. It can protect testing, clinical studies and other activity reasonably related to generating and submitting information to FDA. It does not turn commercial manufacture and sale of a cleared device into non-infringing activity. In Amgen Inc. v. Hospira, Inc., 944 F.3d 1327 (Fed. Cir. 2019), a biologics case, the court affirmed a jury finding that batches the defendant had planned as commercial inventory, and was not required to make for FDA, fell outside the safe harbor. Launch planning should proceed on the understanding that the protection ends where commercial supply begins, and activity near that line warrants careful review.
Enhanced damages for willful infringement remain available. In Halo Electronics, Inc. v. Pulse Electronics, Inc., 579 U.S. 93 (2016), the Supreme Court held that 35 U.S.C. §284 gives district courts discretion to award enhanced damages in egregious cases of misconduct and explained that culpability is generally measured against the knowledge of the actor at the time of the challenged conduct.
Congress has separately addressed legal opinions. Under 35 U.S.C. §298, the failure of an infringer to obtain the advice of counsel, or to present that advice to the court or jury, may not be used to prove that the accused infringer willfully infringed or intended to induce infringement. An FTO opinion is therefore not a statutory prerequisite to launch. Its practical value lies in informing design and launch decisions while there is still time to act on them, and in recording what the company understood when those decisions were made.
Regulatory and patent timelines for a U.S. device launch overlap but do not coincide. Companies preparing a U.S. submission may find it useful to discuss with patent counsel how FTO checkpoints fit alongside their design and regulatory milestones.