Manufacturers should attempt to make comparison of the new device to its predicate as easy as possible for the FDA reviewer. The 510(k) notification should therefore include discussion of the similarities and differences between the device and its predicate device, and should make use of comparative tables whenever possible. Comparisons might con­sider such areas as […]

Although manufacturers may submit drafts of their device labeling, including the label on the immediate container of the device, the submission should be representative of the final version. The directions for use should include a specific statement regarding a clini­cally significant use of the device and any related warnings, contraindications, or limita­tions (e. g., precautions […]

The submitter should identify any mandatory or voluntary standards met by the device, citing each by paragraph or requirement. Although a device need not meet any particular standard, if substantial equivalence is being claimed to one or more predicate devices that do meet a given standard, then the new device should also meet it. Except […]

Include the class of the device, (i. e., Class I, II, or III). If the device has not been classi­fied, the fact needs to be mentioned. If known, include the appropriate classification panel, for example, anesthesiology or orthopedics.117 If the device does not have a classification panel, state how this was determined. For example, the […]

If applicable, supply the FDA establishment registration number of the owner or oper­ator submitting the premarket notification. Registration is not required in order for a company to submit a 510(k); however, it is a good idea to obtain one. This can be accom­plished by filing a Registration Form 2891 with FDA. If this form is […]

All 510(k) submitters must include a statement certifying that all information in the application is truthful and accurate, and that no material fact has been omitted. The state­ment may be in the cover letter, or on a separate page. In either case, the location of this statement should be noted in the table of contents. […]

It is important not to overlook the obvious. Proper identification is crucial. Be sure that the applicant’s name and street address are included; do not use a post office box. Telephone and fax numbers should be included for the contact person, and if that person is not the applicant, special note of that fact should […]

While there is no set formula for presenting these data, there is a general framework in which to follow. That framework is actually an assemblage of major components that, if all are included and the data presented properly, will help ensure that the application is com­plete. Submitters can make FDA’s task easier by using the […]

• Cover letter • Indication for use • 510 (k) summary • Truthful and accuracy statement • Classification summary and certification • Financial certification or disclosure statement • Declaration of conformity and summary reports • Executive summary • Device description • Substantial equivalence discussion • Sterilization and shelf life • Biocompatibility • Software validation • […]