NDA, ANDA, 510(k), PMA: what each FDA approval route means

Information as of 16 October 2026. Everything below comes from the FDA's own pages on each submission type, linked below. If anything here is wrong, tell us at contact@oqro.io and we will correct it.

What is the difference between an NDA, an ANDA and a BLA?

The New Drug Application is the vehicle through which a sponsor proposes that the FDA approve a new drug for sale in the United States. The FDA's page describes what it must contain: the drug's whole story, including the results of animal and human studies, how the drug behaves in the body, and how it is manufactured, processed and packaged. The application is reviewed for safety and effectiveness for its proposed use, whether the benefits outweigh the risks, whether the proposed labeling is appropriate, and whether the manufacturing methods preserve the drug's identity, strength, quality and purity.

An Abbreviated New Drug Application is the route for a generic. The FDA's page explains that it is called abbreviated because the applicant is generally not required to include preclinical and clinical data to establish safety and effectiveness; instead it has to show that its product is bioequivalent to the reference listed drug, performing in the same manner. A generic has to be the same as the brand in dosage form, strength, route of administration, quality, performance characteristics and intended use.

Biologics, such as vaccines and many antibody therapies, go through a Biologics License Application rather than an NDA. A supplement to an approved application, which is how a new indication or a manufacturing change is reviewed, appears in the FDA's records as a submission against the original application number, which is why one product can show several approval dates.

What does a 510(k) clearance show?

A 510(k) is a premarket notification showing that a device is at least as safe and effective as, that is substantially equivalent to, a legally marketed device that is not subject to premarket approval. The FDA's page sets out the test: the device has the same intended use as the predicate, and either the same technological characteristics, or different ones that do not raise different questions of safety and effectiveness, with data showing it is as safe and effective. A 510(k) ends in a clearance, not an approval, and the record carries a K number.

A De Novo classification request is the route for a novel device of low to moderate risk for which no predicate exists. If granted, the device is classified into Class I or Class II and can itself serve as a predicate for later 510(k)s.

When is a PMA required?

A Premarket Approval is the most stringent route. The FDA's page describes it as the process of scientific and regulatory review to evaluate the safety and effectiveness of Class III devices, those that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. A PMA has to stand on its own with valid scientific evidence, typically clinical data, and the record carries a P number. Changes to an approved device that affect its safety or effectiveness go through a PMA supplement.

How does OQRO show FDA records?

The FDA records page lists approvals, clearances and recalls recorded by the FDA for listed companies, newest first, with the product, the kind of action and a link to the FDA record, and a chart of records per month. Each company page carries its own. Recalls are classified by hazard, which our article on recall classes explains, and the studies that precede an application are on the clinical trials page. The records are matched by the sponsor's, applicant's or firm's name as the FDA writes it, so a product filed under a subsidiary that OQRO does not know is not shown.

What this does not tell you

A record says that a submission was approved, cleared or granted on a date, for a product, under a route. It does not say how large the market is, what the company expects to sell, whether a competitor has the same clearance, or whether the product will be launched. A supplement is not a new product, and a clearance is not a finding that the device is better than its predicate. OQRO shows the record as published; it does not interpret it, and nothing here is investment advice.