US FDA Medical Device Regulations.
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Establishment Registration.
Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration.Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires pre-market approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA pre-market submission number (510(k), PMA, PDP, HDE).
Since September, 2007, all registration and listing information must be submitted electronically, unless a waiver has been granted.
Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments.
The following charts detail the requirements for registration and listing based on the type of activity performed at that establishment. The chart also includes a column showing which types of activities require payment of an establishment registration fee. Definitions of each type of activity are detailed subsequent to the chart.
US Establishments (Domestic establishments)
| Activity | Register | List | Pay Fee |
| Contract manufacturer, (including contract packagers) | YES | YES | YES |
| Contract sterilizer | YES | YES | YES |
| Device being investigated under IDE | NO | NO | NO |
| Domestic Distributor that does not import devices | NO | NO | NO |
| Any establishment located in a foreign trade zone involved with the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for commercial distribution in the United States | YES | YES | YES |
| Import agent, broker, and other parties who do not take first possession of a device imported into the United States | NO | NO | NO |
| Initial Importer | YES | NO | YES |
| Maintains complaint files as required under 21 CFR 820.198 | YES | YES | YES |
| Manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user | YES | YES | YES |
| Manufacturer of components, that are not otherwise classified as a finished device, that are distributed only to a finished device manufacturer | NO | NO | NO |
| Manufacturer | YES | YES | YES |
| (including Kit Assemblers) | |||
| Manufactures a custom device | YES | YES | YES |
| Refurbishers or remarketers of used devices already in commercial distribution in the United States. | NO | NO | NO |
| Relabeler or Repackager | YES | YES | YES |
| Remanufacturer | YES | YES | YES |
| Reprocessor of single use devices | YES | YES | YES |
| Specification Consultant Only | NO | NO | NO |
| Specification Developer | YES | YES | YES |
| U.S. Manufacturer of export only devices | YES | YES | YES |
| Wholesale distributor that is not a manufacturer or importer | NO | NO | NO |
Non-US establishments (foreign establishments).
| Activity | Register | List | Pay Fee |
| Contract Manufacturer, (including contract packagers) | YES | YES | YES |
| Contract Sterilizer | YES | YES | YES |
| Custom Device Manufacturers | YES | YES | YES |
| Device Being Investigated under IDE | NO | NO | NO |
| Foreign Exporter of devices located in a foreign country | YES | YES | YES |
| Foreign Manufacturers, (including Kit Assemblers) | YES | YES | YES |
| Maintains complaint files as required under 21 CFR 820.198 | YES | YES | YES |
| Manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user | YES | YES | YES |
| Manufacturer of components that are distributed only to a finished device manufacturer | NO | NO | NO |
| Relabeler or Repackager | YES | YES | YES |
| Remanufacturer | YES | YES | YES |
| Reprocessor of Single-use Device | YES | YES | YES |
| Specification Developer | YES | YES | YES |
Definitions of Establishment Activities:
Contract Manufacturer – Manufactures a finished device to another establishment’s specifications.Contract Sterilizer – Provides a sterilization service for another establishment’s devices.
Foreign Exporter – Exports or offers for export to the United States (U.S.), a device manufactured, prepared, propagated, compounded, or processed in a foreign country, including devices originally manufactured in the United States. A foreign exporter must have an establishment address outside the U.S.
Initial Importer – Any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labelling of the device or device package. The initial importer must have a physical address in the United States staffed by individuals responsible for ensuring the compliance of imported devices with all applicable FDA laws and regulations.
Manufacturer – Makes by chemical, physical, biological, or other procedures, any article that meets the definition of “device” in Section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.
Re-packager – Packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).
Re-labeller – Changes the content of the labelling from that supplied from the original manufacturer for distribution under the establishment’s own name. A relabelled does not include establishments that do not change the original labelling but merely add their own name.
Re-manufacturer – Any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use.
Re-processor of Single Use Device – Performs remanufacturing operations on a single use device.
Specification Developer – Develops specifications for a device that is distributed under the establishment’s own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labelled with another establishment’s name by a contract manufacturer.
U. S. manufacturer of export only devices – Manufactures medical devices that are not sold in the U.S. and are manufactured solely for export to foreign countries.
Information & Training.
Medical Device:
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s. EU MDR’s / MDD’s.
- FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
- FDA Medical Device Classification. The FDA approach to Medical Device Classification.
- EU Medical Device Regulation and Classification (per MDD’s).
- New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
- Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
- Quality System requirements to maintain compliant Validations.
- Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
- Medical Device Software Validation.
- Medical Device Design Validation.
- Electronic Signature, Electronic Records.
- Life Cycle Approach to Validation.
- Risk Identification. Documentation. DHR’s. DMR’s.
- Etc. Etc. …
- Information & Training presentation >>>