REGISTRATION, LISTING AND LABELING

ESTABLISHMENT REGISTRATION

Any place of business under one management, at one physical location where a medical device is manufactured, assembled or processed for commercial distribution is considered an "establishment" requiring registration with Form 2891. Registering your establishment with the CDRH is very simple and there is no fee to do so. It is meant to provide the FDA with little more than the name, type and location of the medical device manufacturing facilities along with the name and address of its owner/operator, whether that owner is a person or corporate entity.

Any owner of an establishment must register within 30 days of commencing any activity that might be seen as requiring registration, including the start of production or the import of a device for commercial distribution. Also, keep in mind that you may not introduce the device for distribution or export unless you are registered and listed at least 90 days prior to that distribution date.

Note: Foreign establishments should be aware of many additional regulations not discussed here.

PRODUCT LISTING

Product listing is fairly easy and free. Listing is meant to provide the CDRH with a general description and classification of the type of device you plan to manufacture or distribute. The on-line listing Form 2892 includes links to help you find information necessary for completing the form, including databases of product codes and guidance instructions for completing the forms. The primary reason for properly identifying the device's classification is so that you pursue the correct development and regulatory path. The CDRH will not tell you whether you have misclassified your device until it reviews the full marketing application (i.e. PMA or 510(k)), at which point the accuracy of the listing will be the least of your concerns. If the device must be reclassified following review, changing the listing at least 90 days prior the marketing will be relatively simple.

Owners are responsible for keeping data on their listing forms current and must be sure to update it when there is either a name change in the marketed device or when any additional intended uses might cause a change of the device classification. Failure to do so may tarnish your image at the FDA.

LABELING

The FDA develops and administers labeling regulations pertaining to how medical devices are used. Before marketing clearance is obtained, the manufacturer must ensure that the device is labeled according to those regulations or risk seriously complicating the approval process.

Sometimes a company may choose not to list a use, knowing that doctors might decide to buy and use the device off-label. Generally, a company would do this when proving safety and efficacy for the unlisted use would incur significant cost or result in an unfavorable classification. For example, if a die applied as a diagnostic had been in use prior to laws that would require classification and it was later discovered to have new properties that might be used in a new, high risk technique, a company may choose not to report it and allow doctors to simply buy the product as currently marketed. By doing so, however, doctors may be taking unreasonable liability risks, which will obviously affect the new technique's commercial and practical success.

Ultimately, the CDRH Secretary determines the intended uses of a device. At any time, the Director may require that the label include appropriate information regarding a novel use not identified in the proposed labeling if there is a reasonable likelihood that the device will have this novel use. Performing the now needed trials for the novel use may pose a significant and unanticipated financial burden to the company and its investors. Therefore, when filing a PMA or 510(k), a company should consider including as many accessories and uses as possible to avoid unnecessarily filing for changes or equivalence.

MEDICAL DEVICE CLASSIFICATION

When you list with Form FDA-2892 you will need to determine the Class of your device. Although your device will be listed under one of 16 panels (medical specialties) and given a number identifying it within that panel, it can only be classified as a Class I, Class II or Class III device. Consult a regulatory attorney if there are ambiguities regarding classification. It can be the most critical regulatory element since class impacts regulatory requirements substantially.

Shortly after passage of the Medical Device Amendments of 1976, the Office of the Secretary organized panels of experts to provide review and recommendation to FDA regarding the classification of over 1800 device types. Their recommendations have been codified in classified regulations found in 21 CFR 800-1299. After discharging these responsibilities, these same panels converted to the advisory panels used today. The panels continue to make recommendations to FDA on issues ranging from classification to the approvability of PMAs.

To find the classification of your device, as well as any potential exemptions, go directly to the product code classification database and search for a part of the device name, or, if you know the device panel (the medical specialty) to which your device belongs you can go directly to the Code of Federal Regulation and find the classification for your device by reading through the list of classified devices. You can also check the classification regulations and the precedent correspondence for information on how various products are regulated by the CDRH.

Class I: These devices do not present an unreasonable risk of illness or injury and are generally exempt from the marketing application process. Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments.

Although many Class I devices will be exempt from the marketing application process the FDA has identified what are referred to as general controls to ensure safety and efficacy of even these low risk devices. Various general controls will apply to Class I devices as the CDRH deems necessary. These controls include but are not limited to:

  • Registration and listing
  • Compliance with adulteration & misbranding regulations
  • Compliance with Quality Systems Regulations (formerly Good Manufacturing Practices or GMPs)
  • Record Keeping and reporting requirements
  • Repair, replacement and refund practices

Class II: Class II devices may help support or sustain human life and pose some risk of injury or ailment. When general controls alone are insufficient to provide reasonable assurance of safety and effectiveness but information to provide such assurances is available through what the FDA calls special controls, a product will be listed as a Class II device. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes.

Special controls include but are not limited to:

  • Development and dissemination of guidelines, including guidelines for the submission of clinical data for applications aimed at getting recognition of substantial equivalence to a previously marketed device.
  • Performance Standards
  • Post-market Surveillance
  • Patient registries
  • Recommendations for compliance improvement

Class III: These are high-risk devices and require PMA filing providing reasonable assurance of safety and effectiveness. Examples of Class III devices that require a PMA include replacement heart valves, silicone gel-filled breast implants, and implanted cerebella stimulators. When considering the classification of your device, keep in mind that safety, efficacy, and classification are judged relative to the needs of the intended patient.