Approval routes, expedited programs and designations, with steps, official time targets, fees and reliance. Last verified October 3, 2026.
Routes on this page
25
Reviewed
Product types
9
Drugs, devices and more
Shortest review target
90 days
Premarket notification (510(k))
Approvals in the data
203,087
As of October 3, 2026
United States has 25 reviewed approval routes and programs on this page. The main routes for new medicines are New drug application (full, new active ingredient), New drug application relying on other data (505(b)(2)), Biologics license application (351(a)).
Among the routes with an official review target, Premarket notification (510(k)) has the shortest target: 90 days. Targets are not actual review times.
11 routes
The standard route for a new medicine. The company sends a full application with its own clinical and nonclinical studies and manufacturing data. The agency first checks whether the file can be accepted, then reviews it and either approves it or sends a complete response letter that lists the problems.
Full application, new active substance · target 304 days · verified October 3, 2026
A new drug application that relies in part on studies that were not run by or for the applicant, and that the applicant has no right to use. The applicant adds its own data to bridge to that evidence and certifies the status of the related patents.
Full or mixed application, known active substance · target 304 days · verified October 3, 2026
A designation for drugs and biologics for serious or life-threatening conditions when early clinical evidence suggests substantial improvement over existing therapies. It brings more meetings, timely advice and involvement of senior staff during development.
Intensive development support designation · verified October 3, 2026
A designation for drugs that treat serious or life-threatening conditions and could meet an unmet medical need. The agency can review completed sections of the application before the whole application is sent (rolling review).
Rolling or phased review · verified October 3, 2026
Approval for a serious or life-threatening condition based on an effect on a surrogate endpoint, or an intermediate clinical endpoint, that is reasonably likely to predict clinical benefit. Confirmatory studies are required, and the agency can require them to be underway before approval. Approval can be withdrawn through an expedited procedure.
Conditional or accelerated approval · verified October 3, 2026
With priority review, the agency's goal is to act on the application in 6 months instead of 10. For a new molecular entity or an original biologics license application, the 6 months run from the 60-day filing date.
Priority or accelerated review · target 183 days · verified October 3, 2026
A designation for drugs and biologics for rare diseases, generally those affecting fewer than 200,000 people in the United States. After approval, the product can get seven years of market exclusivity for the designated use, and the application is not charged the application fee if it covers only rare disease uses.
Orphan or rare disease designation · verified October 3, 2026
A pilot program announced in June 2025. A voucher gives a much faster review target, about 1 to 2 months, for a product that fits one of five national health priorities. Approval standards stay the same. Vouchers cannot be transferred.
Priority or accelerated review · verified October 3, 2026
During a declared emergency, the agency can authorize an unapproved product, or an unapproved use, when it is reasonable to believe the product may be effective and there is no adequate, approved and available alternative.
Emergency or temporary authorisation · verified October 3, 2026
An unapproved investigational drug can be used to treat patients outside clinical trials when they have a serious or immediately life-threatening condition and no comparable or satisfactory alternative. Requests can cover one patient, a group, or a wider treatment use. In an emergency, use can start before a written request.
Early or compassionate access · verified October 3, 2026
Applications for a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration must include pediatric assessments. The data must assess safety and effectiveness in all relevant pediatric age groups.
Pediatric plan or incentive · verified October 3, 2026
1 routes
The route for new biological products, including vaccines and cell and gene therapies. The license is based on showing that the product is safe, pure and potent, and that the facility meets standards. The agency can require that each lot is released by it before distribution.
Full application, new active substance · target 304 days · verified October 3, 2026
1 routes
The route for a biological product that is highly similar to an already licensed reference product, with no clinically meaningful differences in safety, purity and potency. A product can also be licensed as interchangeable, which means it may be substituted for the reference product.
Biosimilar application · target 304 days · verified October 3, 2026
1 routes
The route for a generic copy of an approved drug. The company shows that its product is bioequivalent to the reference listed drug instead of repeating clinical trials. The first applicants to challenge a patent can earn a 180-day exclusivity period.
Generic application · target 304 days · verified October 3, 2026
2 routes
Nonprescription drugs that meet a monograph can be sold without an individual approval. The agency sets or changes monograph conditions through administrative orders, on its own initiative or at the request of a company. A drug that meets the order is treated as generally recognized as safe and effective.
Non-prescription monograph · verified October 3, 2026
A prescription drug approved under a new drug application can be moved to nonprescription status. The company can ask through a supplement to its approved application or a petition. The agency must find that the drug is safe and effective for self-medication as directed in the proposed labeling.
Non-prescription application · verified October 3, 2026
1 routes
A designation for regenerative medicine therapies, such as cell therapies, that treat serious or life-threatening conditions and show early clinical potential to address unmet needs. It gives access to expedited development and review.
Intensive development support designation · verified October 3, 2026
1 routes
A product that combines a drug, a device or a biological product is assigned to one lead center. The lead is set by the primary mode of action, the part expected to make the greatest contribution to the intended effect. A company can ask for a formal designation, and the product then follows that center's premarket route.
Other route · verified October 3, 2026
6 routes
The maker shows that the device is substantially equivalent to a device already legally sold in the United States (the predicate). The notification is sent at least 90 days before the device is put on the market. It is used for devices that are not exempt and do not need premarket approval.
Device: premarket notification · target 90 days · verified October 3, 2026
A route for a new type of device with no predicate, where general controls, or general and special controls, can give reasonable assurance of safety and effectiveness. If granted, the device is classified into Class I or II.
Device: new low or moderate risk device · target 150 days · verified October 3, 2026
The route for Class III devices, the highest-risk class, that require premarket approval. The application has separate sections on nonclinical laboratory studies and clinical investigations. Some applications go to an advisory panel, which has a longer review goal.
Device: premarket approval by the regulator · target 180 days · verified October 3, 2026
A route for devices that treat or diagnose diseases or conditions that affect not more than 8,000 people in the United States. The device is exempt from the effectiveness requirements, but its probable benefit to health must outweigh its risks.
Device: humanitarian or limited population route · verified October 3, 2026
Device types classified in Class I do not need a premarket notification, with exceptions. Class I devices of substantial importance in preventing impairment of health, or with a potential unreasonable risk, still need one. Exempt devices follow the general controls, such as registration and listing.
Device: exempt or self-declared · verified October 3, 2026
A program for devices that give more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions, and that are a breakthrough technology, have no cleared or approved alternative, offer significant advantages, or are in the best interest of patients. Designated devices get priority review and closer interaction during development.
Device: breakthrough or priority program · verified October 3, 2026
1 routes
Software that meets the device definition goes through the normal device routes (510(k), De Novo or PMA) according to its risk class. Some software functions were removed from the device definition by law, and the agency focuses its oversight on software that poses a greater risk if it does not work as intended. A predetermined change control plan can cover planned updates.
Other route · verified October 3, 2026
Recent changes and pending reforms
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Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.