Acceptance Checklist for Special 510(k)s

Performance data are needed to evaluate the change. If a manufacturer determines under their design control procedures that no additional verification or validation testing is necessary to evaluate a change, manufacturers may submit these changes as a Special 510(k) with a clear rationale supporting their conclusion that no performance data are necessary. When FDA does not agree with the manufacturer's assessment, FDA intends to continue with the additional Special 510(k) factors.

There is a well-established method to evaluate the change. Well-established methods include those used in the previously cleared 510(k), an FDArecognized consensus standard or FDA guidance document, qualified medical device development tools (MDDTs), are widely available and accepted, or found acceptable through a different premarket submission by the same manufacturer of the predicate.

The data be reviewed in a summary or risk analysis format.The results from verification and validation associated with design or labeling changes should be able to be placed in a summary or risk analysis format without losing information necessary to support SE. Complete test reports should not be submitted in a Special 510(k). If complete test reports are submitted, FDA intends to assess whether the information can be reviewed in a summary format before converting to a Traditional 510(k).

Submission contains a Table of Contents.

Each section is labeled (e.g., headings or tabs designating Device Description section, Labeling section, etc.).

All pages of the submission are numbered.
All pages should be numbered in such a manner that information can be referenced by page number. This may be done either by consecutively numbering the entire submission, or numbering the pages within a section (e.g., 12-1, 12-2…).

Type of 510(k) is identified (i.e., Traditional, Abbreviated, or Special)
If type of 510(k) is not designated, review as a Traditional 510(k).

• Any "No" answer will result in a "Refuse to Accept" decision; however, FDA staff has discretion to determine whether missing items are needed to ensure that the submission is administratively complete to allow the submission to be accepted or to request missing checklist items interactively from submitters during the RTA review.
• Each element on the checklist should be addressed within the submission. The submitter may provide a rationale for omission for any criteria that are deemed not applicable. If a rationale is provided, the criterion is considered present (Yes). An assessment of the rationale will be considered during the review of the submission.

All content used to support the submission is written in English (including translations of test reports, literature articles, etc.).

Submission identifies the following (FDA recommends use of the CDRH Premarket Review Submission Cover Sheet form (Form 3514):

Device trade/proprietary name

Device class and panel OR
Classification regulation OR
Statement that device has not been classified with rationale for that conclusion

Submission contains an Indications for Use Statement with Rx and/or OTC designated (see also 21 CFR 801.109, and FDA’s guidance “Alternative to Certain Prescription Devices Labeling Requirements” ) See recommended format.

Submission contains a 510(k) Summary or 510(k) Statement.
Refer to 21 CFR 807.92 and 21 CFR 807.93 for contents of 510(k) Summary and Statement, respectively. Adequacy of the content will be assessed during substantive review.

Submission contains a Truthful and Accuracy Statement per 21 CFR 807.87(l).
See recommended format

Submission is a Class III 510(k) Device.
Select “N/A” only if submission is not a Class III 510(k).

Contains Class III Summary and Certification per 21 CFR 807.87(k).
See recommended content. Select “N/A” only if submission is not a Class III 510(k).

The submission identifies prior submissions for the same device included in the current submission (e.g., submission numbers for a prior not substantially equivalent [NSE] determination, prior deleted or withdrawn 510(k), Q-Submission, IDE, PMA, etc.).
OR
States that there were no prior submissions for the subject device.
Prior submissions (or no prior submissions) for this device should be included in Section F (prior related submissions) of the CDRH Premarket Review Submission Cover Sheet form (Form 3514). This information may also be included in the Cover Letter (i.e., as a statement that there were no prior submissions for the device or a listing of the number(s) of the prior submissions).

If there were prior submissions, the submitter has identified where in the current submission any issues related to a determination of substantial equivalence from prior submissions for this device are addressed.
To address this criterion, it is recommended that the submission include a separate section with the prior submission number(s), a copy of the FDA feedback (e.g., letter, meeting minutes), and a statement of how or where in the submission this prior feedback was addressed. Note that adequacy of how the feedback was addressed will be assessed during the substantive review.
Select “N/A” if the submitter states there were no prior submissions.

The submission utilizes voluntary consensus standard(s) (See section 514(c) of the FD&C Act). This includes both FDA- recognized and non-recognized consensus standards. Select “N/A” if the submission does not utilize voluntary consensus standards.

The submission cites FDA-recognized voluntary consensus standard(s).

i.
The submission includes a Declaration of Conformity (DOC) as outlined in FDA’s guidance “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, ”
OR
If citing general use of a standard as noted in FDA’s guidance “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices,”the basis of such use is included along with the underlying information or data that supports how the standard was used.

The submission cites non-FDA-recognized voluntary consensus standard(s).

i. The basis of use is included along with the underlying information or data that supports how the standard was used.

Combination Product Provisions – Per 503(g) of the FD&C Act. Select N/A if the product is not a combination product. 21 CFR 3.2(e). The remaining criteria in this section will be omitted from the checklist if "N/A" is selected. If you are unsure if the product is a combination product, consult with the CDRH Product Jurisdiction Officer or CBER Product Jurisdiction Officer.

Submission identifies the product as a combination product.

The combination product contains as a constituent part an approved drug as defined in section 503(g)(5)(B) of the FD&C Act. Select “N/A” if the combination product does not contain as a constituent part an approved drug. Please also select “N/A” if a right of reference or use for the drug constituent part(s) is included with the submission. If “N/A” is selected, part a below is omitted from the checklist.

The submission includes appropriate patent statement or certification and a statement that the submitter will give notice, as applicable. See 503(g)(5)(A)&(C).

The device has a device-specific guidance document, special controls, and/or requirements in a device-specific classification regulation regarding the device description that is applicable to the subject device.
If “N/A” is selected, parts a and b below are omitted from the checklist.

The submission addresses device description recommendations outlined in the device-specific guidance.
OR
The submission provides an alternative approach intended to address the applicable statutory and/or regulatory criteria.
Select “N/A” if there is no applicable device-specific guidance. Select “No” if the submission does not include a rationale for any omitted information or any alternative approach as outlined above. Note that the adequacy of how recommendations in a device-specific guidance, etc., have been addressed should be assessed during the substantive review.

The submission includes device description information that addresses relevant mitigation measures set forth in the special controls or device-specific classification regulation applicable to the device.
OR
The submission uses alternative mitigation measures and provides rationale why the alternative measures provide an equivalent assurance of safety and effectiveness.
Select “N/A” if there are no applicable special controls or device-specific classification regulation. Select “No” if the submission does not include a rationale for any omitted information or any alternative approach as outlined above.

Note that the adequacy of how such mitigation measures have been addressed should be assessed during the substantive review.

Descriptive information is present and consistent within the submission (e.g., the device description section is consistent with the device description in the labeling).

The submission includes descriptive information for the device, including the following:

A description of the principle of operation or mechanism of action for achieving the intended effect.

A description of proposed conditions of use, such as surgical technique for implants; anatomical location of use; user interface; how the device interacts with other devices; and/or how the device interacts with the patient.

A list and description of each device for which clearance is requested.
Select “N/A” if there is only one device or model. “Device” may refer to models, part numbers, various sizes, etc.

Submission contains representative engineering drawing(s), schematics, illustrations, photos and/or figures of the device.
OR
Submission includes a statement that engineering drawings, schematics, etc. are not applicable to the device (e.g., device is a reagent and figures are not pertinent to describe the device).
In lieu of engineering drawings, schematics, etc. of each device to be marketed, “representative” drawings, etc. may be provided, where “representative” is intended to mean that the drawings, etc. provided capture the differences in design, size, and other important characteristics of the various models, sizes, or versions of the device(s) to be marketed.

A detailed description of all device modification(s) including rationale for each modification.
When labeling or specific technological characteristics (e.g., materials, dimensions) are unchanged in comparison to the predicate, the submission should clearly state that no changes were made.

Device is intended to be marketed with accessories and/or as part of a system.
Select “N/A” if the device is not intended to be marketed with accessories and/or as part of a system. If “N/A” is selected, parts a-c below are omitted from the checklist.

Submission includes a list of all accessories to be marketed with the subject device.

Submission includes a description (as detailed in item 13a., 13b., and 13d. above) of each accessory.
Select “N/A” if the accessory(ies) has been previously cleared, or is exempt, and the proposed indications for use are consistent with the cleared indications.

A 510(k) number is provided for each accessory that received a prior 510(k) clearance
AND
A statement is provided that identifies accessories that have not received prior 510(k) clearance.

Submitter has identified a predicate device(s), including the following information:

Predicate device identifier provided (e.g., 510(k) number, De Novo number, reclassified PMA number, classification regulation reference, if exempt (e.g., 21 CFR 872.3710), or statement that the predicate is a preamendment device).
For predicates that are preamendments devices, information is provided to document preamendments status.
Information regarding documenting preamendment status is available online.

The identified predicate(s) is consistent throughout the submission (e.g., the predicate(s) identified in the Substantial Equivalence section is the same as that listed in the 510(k) Summary (if applicable) and that used in comparative performance testing.

Submission includes a comparison of the following for the predicate(s) and subject device and a discussion why any differences between the subject and predicate(s) do not impact safety and effectiveness [see section 513(i)(1)(A) of the FD&C Act and 21 CFR 807.87(f)]
See the FDA guidance document “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)],” for more information on comparing intended use and technological characteristics.

Indications for use
If there are no differences between the subject device and the predicate(s) with respect to indications and intended use, this should be explicitly stated.

Technology, including technical specifications, features, materials, and principles of operation
Examples of technological characteristics include, but are not limited to design, features, materials, energy source, and principle of operation.
FDA recommends a tabular format for comparing technological characteristics. Any characteristic that is the same as the predicate(s) should be explicitly stated.
Differences in technological characteristics should be identified and a rationale provided why they do not raise different questions of safety and effectiveness.

Design Control Activities Summary includes all of the following:

Identification of risk analysis method(s) used to assess the impact of the modification on the device AND the results of the analysis.

Identification of the device change(s).

Identification of all risks associated with each device change, including identification of risks that are considered new because of the change; and

Risk control measures to mitigate identified risks (e.g., labeling, verification).

Based on the Risk Analysis, an identification of the verification and/or validation activities required to comply with 21 CFR 820.30. This identification includes a summary of test methods (including any protocol deviations), acceptance criteria, results in a summary or risk analysis format (e.g., basic descriptive statistics, where appropriate), and why each is adequate to establish substantial equivalence. If unchanged from a previous premarket submission, the manufacturer references the location of protocols and acceptance criteria by providing a submission and section numbers.

i. For non-standardized test methods only:

• A reference to the protocol used for the existing device with an identification of any differences (e.g., protocol, test conditions, pre-defined acceptance criteria, sample size) from the previous 510(k). If protocol changes were made, the results summary describes why the test methods, acceptance criteria, and results support SE.

A signed statement by the manufacturer’s designated individual(s) responsible for design control activities. Both items below must be present to answer “Yes.”

1. Statement that, as required by the risk analysis, all verification and validation activities were performed by designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met.
2. Statement that the submitter has complied and is not currently in violation of the design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review, upon request.

Submission includes proposed package labels and labeling (e.g., instructions for use, package insert, operator's manual).

All changes in proposed labeling resulting from device modification(s) are highlighted or prominently identified.
FDA recommends clean and redlined copies be provided.