Abbreviated 510(k)

There are three types of 510(k) submissions. These include Traditional, Special and Abbreviated. The new 510(k) paradigm offers Special and Abbreviated approaches to the traditional 510(k) method to help streamline the 510 (K) review process. While the Special 510(k) utilizes certain aspects of the Quality System Regulation (QSR), the Abbreviated 510(k) depend on on the use of guidance documents, special controls, and recognized standards.

All the elements identified in 21 CFR 807.87 (Traditional 510(k) submissions) should be included in abbreviated 510(k). However, in this type of submission, manufacturers choose to provide summary reports on the use of guidance documents and/or special controls, or declarations of conformity to recognized standards, to expedite the review of a submission.

Guidance Documents

A summary report explaining adherence to the pertinent guidance document and how it was used during device development and testing should be included while submitting abbreviated 510(k).

Special Controls

As defined in section 513(a)(1)(B) of FDA&C Act, special controls such as performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendation and others provide reasonable assurance of the safety and effectiveness of device. An Abbreviated 510(k) that relies on a special control(s) should include

• a summary report that describes adherence to the special control and how the special control(s) was used during device development and testing
• how the special control(s) was used to address a specific risk or issue
• information regarding the manufacturer's efforts to conform with the special control(s) and should outline any deviations.

FDA Recognized Standards

An Abbreviated 510(k) that relies on a recognized standard must include a Declaration of Conformity to the recognized standard. Under certain conditions, conformance test data are not required to be submitted in the 510(k).

Declarations of conformity to recognized standards should include the following:

• An identification of the applicable recognized consensus standards that were met
• A specification, for each consensus standard, that all requirements were met
• An identification, for each consensus standard, of any way(s) in which the standard may have been adapted for submission to the device under review, e.g., an identification of an alternative series of tests that were performed
• An identification, for each consensus standard, of any requirements that were not applicable to the device
• A specification of any deviations from each applicable standard that were applied
• A specification of the differences that may exist, if any, between the tested device and the device to be marketed and a justification of the test results in these areas of difference
• The name and address of any test laboratory or certification body involved in determining the conformance of the device with the applicable consensus standards and a reference to any accreditations of those organizations.

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