top of page

FDA Medical Device: How to prepare a 510(k)?

January 04 2023



There are three types of Premarket Notification 510(k)s that may be submitted to the FDA: Traditional, Special, and Abbreviated.



Special 510(k):


The Special 510(k) Program provides a least burdensome approach to the review of certain changes to a manufacturer's own legally marketed predicate device ("existing device") because a Special 510(k) provides an efficient pathway for manufacturers to provide the minimum required information necessary to establish SE for a modified device. Because of this efficiency, we intend to process Special 510(k)s within 30 days of receipt by the Document Control Center (DCC), rather than the 90 days for 510(k)s required by section 510(n)(1) of the FD&C Act.


The FDA's current approach for the Special 510(k) Program focuses on whether the method(s) to evaluate the change(s) are well-established, and whether the results can be sufficiently reviewed in a summary or risk analysis format.



When to Choose a Special 510(k)


A design or labeling change to an existing device (including certain changes to the indications for use) may be appropriate for a Special 510(k) when:


  • The proposed change is submitted by the manufacturer legally authorized to market the existing device,

  • Performance data are unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change, and

  • All performance data necessary to support substantial equivalence can be reviewed in a summary or risk analysis format.


If the FDA determines that a Special is not appropriate for review as submitted, the FDA intends to notify the submitter of this decision and convert the 510(k) to a Traditional 510(k). If the 510(k) is converted, the original receipt date remains as the start of the review period. Manufacturers should be aware that, in most cases, additional information will be necessary for converted documents.




Traditional 510(k):


The Traditional 510(k) Program can be used under any circumstance to seek marketing authorization of a device through the 510(k) Program.


There is no Premarket Notification 510(k) "form" to complete. A 510(k) is a submission containing information required under 21 CFR 807.87. All 510(k)s are based on the concept of substantial equivalence (SE) to a legally marketed device, also referred to as a predicate. All 510(k)s provide a comparison between the device to be marketed and the predicate device or devices.



Find a Predicate Device


You should identify a primary predicate device which is most similar to the device you intend on submitting through the 510(k) Program with respect to indications for use and technological characteristics. Under certain circumstances, you may claim SE to more than one predicate.




Abbreviated 510(k):


The Abbreviated 510(k) relies on the use of guidance documents, special controls, and voluntary consensus standards. Under certain conditions, you may not need to submit test data in an Abbreviated 510(k).



When to Choose a Special 510(k)


Device manufacturers may choose to submit an Abbreviated 510(k) when the submission relies on:


  • FDA guidance document(s),

  • Demonstration of compliance with special controls for the device type, or

  • voluntary consensus standard(s).


In an Abbreviated 510(k) submission, manufacturers provide summary reports based on the use of guidance documents and/or special controls, or declarations of conformity to recognized standards, to facilitate the FDA's review of a submission.


If the FDA determines that an Abbreviated 510(k) is not appropriate for review as submitted, the FDA will notify the submitter of this decision and convert the 510(k) to a Traditional 510(k). If the 510(k) is converted, the original receipt date remains as the start of the review period. Manufacturers should be aware that, in most cases, additional information will be necessary for converted documents.



Special Controls


Special controls are a means of providing reasonable assurance of the safety and effectiveness for a Class II device. Special controls are defined in section 513(a)(1)(B) of the Federal Food, Drug, & Cosmetic Act (Act) as those controls, such as performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines (including guidelines for the submission of clinical data), recommendations and other appropriate actions that provide reasonable assurance of the device's safety and effectiveness.


An Abbreviated 510(k) that relies on special control(s) should include a summary report that describes adherence to the special control(s) and how the device complies with the special control(s), including how the special control(s) were used to address a specific risk or issue. The summary report should include information regarding the manufacturer's efforts to comply with the special control(s) and should outline any deviations.





We will streamline the regulatory processes so that our clients can utilize

their time and money most efficiently.



Experience the best FDA approval directions and solutions!



If you have questions about FDA regulation of medical devices

or importing of medical devices to the United States,


Office 1-909-493-3276













Source:

Commentaires


Post: Blog2_Post
bottom of page