FDA and CDRH Authority over Medical Devices in the United States

1. Key takeaways

The regulatory authority for medical devices in the United States is the Food and Drug Administration (FDA). Within the Agency, the Center for Devices and Radiological Health (CDRH) is responsible for the premarket review, establishment registration and device listing, and facility inspection of the overwhelming majority of devices, while the Center for Biologics Evaluation and Research (CBER) has jurisdiction over devices that fall within the definition of a biological product, such as certain in vitro diagnostic reagents and blood-related products. For enterprises that export devices from outside the United States, none of these obligations are reduced or waived because of where the product is manufactured. A foreign company is measured against exactly the same statutory framework as a domestic one, and its production facilities remain squarely within FDA’s inspection reach. Understanding which center holds jurisdiction over a given product is therefore the first and most consequential decision in any United States market-entry plan, because it determines the reviewing office, the submission prefix, and the shape of the entire compliance file that follows.

• CDRH handles most device manufacturers, including establishments that manufacture, repackage, relabel, or import medical devices, and it also regulates radiation-emitting electronic products.
• CBER exercises jurisdiction over device-type products that meet the definition of biologics under section 351 of the Public Health Service Act.
• United States oversight is dual-track: establishment registration locks down the manufacturing or import location, and device listing locks down the association between each product and that location.
• Premarket authorization is a separate third track, evidenced by a 510(k) substantial equivalence letter, a PMA approval letter, or a De Novo authorization letter.
• Foreign establishments accept FDA on-site inspection and carry device tracking (where applicable) and adverse event reporting duties.

2. Legal basis

The table below lists the principal authorities that define who regulates what in the United States device system. Each entry was confirmed against the cited source during the verification pass for this guide, and the identifiers are reproduced exactly as they appear in the Federal Register and the electronic Code of Federal Regulations, so that the reader can trace every obligation back to its statutory text without intermediate interpretation.

3. Expert insights

Insight one: the dividing line between CDRH and CBER is product attributes, not risk level.

CDRH covers enterprises that manufacture, repackage, relabel, and/or import medical devices, and it additionally regulates radiation-emitting electronic products; CBER takes jurisdiction over device-type products that fall within section 351 of the Public Health Service Act as biologics. When GRZAN takes on an in vitro diagnostic project, the first working step is to determine whether the product falls into product code 862 (clinical chemistry and toxicology) or belongs to CBER, because that single determination decides the reviewing center and the acceptance number prefix (CDRH uses K, CBER uses BK). Getting this step wrong does not merely delay a submission; it sends the entire dossier to an office that cannot act on it, and every downstream document, from the listing record to the correspondence cover sheets, has to be rebuilt around the correct center. Teams that treat center assignment as a formality rather than a determination tend to discover the error only when FDA queries the file, at which point the correction costs far more than the original analysis would have.

Insight two: the regulated object is a dual track of establishment plus product, not a single product license.

The United States does not issue a product registration certificate as a legal document. The obligations of an enterprise are split into two tracks: Establishment Registration locks down the production or import location, and Device Listing locks down the association between the product and that location. Market authorization at the product level forms a third track, expressed through a 510(k) substantial equivalence letter, a PMA approval letter, or a De Novo authorization letter. All three tracks are indispensable, and none of them substitutes for another. A company that holds a cleared submission but has never registered its facility is still out of compliance, and so is a registered facility whose products were never listed. Managing these tracks as a single integrated ledger, in which every registration number, every listing number, and every authorization letter can be cross-checked against the others, is the most reliable way to keep the structure intact through years of updates, ownership changes, and product additions.

Insight three: foreign enterprises and domestic enterprises are subject to the same set of obligations.

FDA’s official guidance states plainly that foreign manufacturers must comply with the applicable requirements before export and import, during import, and after import. Foreign manufacturing facilities are subject to FDA on-site inspection, and they bear device tracking obligations where applicable as well as adverse event reporting duties. This is a direct correction of the misconception that the United States only regulates importers. The foreign status of a facility changes nothing about the substance of the compliance program; it only adds the practical dimension of preparing for an inspection team that may arrive at any time, which in turn means that quality system documentation, complaint records, and device history records must be maintained in a continuously inspection-ready state rather than assembled retrospectively.

4. Practical recommendations

• At project initiation, perform a center-assignment determination first: establish whether the product falls under CBER jurisdiction as a biological product under section 351 of the Public Health Service Act, so that the dossier is never filed with the wrong center.
• Maintain a three-track ledger recording establishment registration numbers, device listing numbers, and premarket authorization letters, with the correspondence between them traceable item by item at any time.
• Prepare every foreign manufacturing facility for inspection on a standing basis: QMSR documentation, complaint and CAPA records, and the DMR and DHR should be retrievable on demand, not reconstructed for each visit.
• Run radiation-emitting electronic products as a separate work line: beyond the device requirements, the radiation safety performance standards and product reporting obligations of Subchapter C of the FD&C Act must also be satisfied.

5. Verification checklist

• □ It has been determined whether the product belongs to CDRH or CBER, and the basis for the determination is documented.
• □ It has been confirmed whether each manufacturing location is subject to FDA on-site inspection.
• □ A ledger mapping establishment registration numbers to listing numbers has been established.
• □ It has been determined whether the product is a radiation-emitting electronic product; if so, product reporting and an accession number have been planned.
• □ A formal Official Correspondent has been designated, whose email account can receive FDA number notifications.

Regulatory information verified as of October 28, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, US Agent and local testing support for the United States market. Our team manages FDA establishment registration and listing, 510(k)/De Novo/PMA submissions, and supports post-market reporting obligations. Business enquiries: info@grzanglobal.com