Acceptance Checklist Abbreviated 510(k)

Is the product a device (per section 201(h) of the FD&C Act) or a combination product (per 21 CFR 3.2(e)) with a device constituent part subject to review in a 510(k)?

If it appears not to be a device (per section 201(h) of the FD&C Act) or such a combination product, or you are unsure, consult with the CDRH Jurisdictional Officer or the CBER Product Jurisdiction Liaison to determine the appropriate action, and inform division management. Provide a summary of the Jurisdictional Officer’s/Liaison’s determination. If the product does not appear to be a device or such a combination product, mark “No.”

Is the submission with the appropriate Center?

If the product is a device or a combination product with a device constituent part, is it subject to review by the Center in which the submission was received?  If you believe the submission is not with the appropriate Center or you are unsure, consult with the CDRH Jurisdictional Officer or the CBER Product Jurisdiction Liaison to determine the appropriate action and inform your division management. Provide a summary of the Jurisdictional Officer’s/Liaison’s determination. If submission should not be reviewed by your Center mark “No.”

If a Request for Designation (RFD) was submitted for the device or combination product with a device constituent part and assigned to your center, identify the RFD # and confirm the following:

1. Is the device or combination product the same (e.g., design, formulation) as that presented in the RFD submission?
2. Are the indications for use for the device or combination product identified in the 510(k) the same as those identified in the RFD submission?

If you believe the product or the indications presented in the 510(k) have changed from the RFD, or you are unsure, consult with the CDRH Jurisdictional Officer or the CBER Product Jurisdiction Liaison to determine the appropriate action and inform your division management. Provide summary of Jurisdictional Officer’s/Liaison’s determination.

If the answer to either question above is no, mark “No.” If there was no RFD, mark “N/A.”

Is the submission for a combination product that contains as a constituent part an approved drug that is under exclusive marketing rights? (503(g)(5))

If “Yes,” then contact the CDRH Jurisdictional Officer or CBER Office of Jurisdiction Liaison, provide a summary of the discussion with them, and indicate their recommendation/action.

Is this device type eligible for a 510(k) submission?

If a 510(k) does not appear to be appropriate (e.g., Class III type and PMA required, or Class I or II type and 510(k)-exempt), you should consult with the CDRH 510(k) Program Director or appropriate CBER staff during the acceptance review. If 510(k) is not the appropriate regulatory submission, mark “No.”

Is there a pending PMA for the same device with the same indications for use?

If yes, consult division management and the CDRH 510(k) Program Director or appropriate CBER staff to determine the appropriate action.

If clinical studies have been submitted, is the submitter the subject of an Application Integrity Policy (AIP)?

If yes, consult with the CDRH Office of Compliance/Division of Bioresearch Monitoring (OC/DBM) or CBER Office of Compliance and Biologics Quality/Division of Inspections and Surveillance/Bioresearch Monitoring Branch (OCBQ/DIS/BMB) to determine the appropriate action. Check on web at here.

If no clinical studies have been submitted, mark "N/A."

Submission relies on a device-specific guidance document, other than a special controls guidance document, and a summary report is provided that:

Select “N/A” if submission does not rely on any device-specific guidance document(s). If “Yes,” address parts a and b below.

Includes a description of adherence to the relevant guidance document to support substantial equivalence.

Includes a description of how the guidance document was used to satisfy the requirements of 21 CFR 807.87 (e.g., data to support substantial equivalence) and lists any deviations.
Select “No” if the sponsor does not address whether there were deviations.

Submission relies on a special control(s), either in a device-specific regulation or special controls document, as defined in Section 513(a)(1)(B) of the FD&C Act, to demonstrate substantial equivalence and a summary report is provided that:

Select “N/A” if submission does not rely on any device-specific guidance document(s). If “Yes,” address parts a and b below.

Includes a description of adherence to the special control(s) to support substantial equivalence.

Includes a description of how the special control(s) was used to satisfy the requirements of 21 CFR 807.87 (e.g., data to support substantial equivalence) and lists any deviations

Submission relies on FDA-recognized consensus standard(s) (See section 514(c)).

For each cited standard:

Submission includes:

1. The device specific conformity statement as specified in device-specific guidance document (e.g., latex condoms), or
2. a declaration for conformity to the device specific standard.

OR

An identification of the applicable FDA-recognized consensus standards (full citation including version number)

An identification, for each consensus standard, of any adaptations of the standard for evaluation of 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 items (e.g., normative requirements of the standard) applicable to your device

A specification of any deviations from each applicable standard (e.g., deviations from international standards which are necessary to meet

A specification of the differences that may exist, if any, between the tested device and the device to be marketed and a justification for the applicability of the test results in these areas of differences.

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(k).
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
See recommended content. Select “N/A” only if submission is not a Class III 510(k).

Submission contains clinical data.
Select "N/A" if the submission does not contain clinical data. If "N/A"is selected, parts a and b below are omitted from the checklist.

Submission includes completed Financial Certification (FDA Form 3454) or Disclosure (FDA Form 3455) information for each covered clinical study included in the submission.
Select “N/A” if the submitted clinical data is not a “covered clinical study” as defined in the Guidance for Industry- Financial Disclosures by Clinical Investigators

Submission includes completed Certification of Compliance with requirements of ClinicalTrials.gov Data Bank (FDA Form 3674) (42 U.S.C. 282(j)(5)(B)) for each applicable device clinical trial included in the submission.
Select “N/A” if the submitted clinical data is not an “applicable device clinical trial” as defined in Title VIII of FDAAA, Sec. 801(j)

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), Pre-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.

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 Jurisdictional Officer or CBER Product Jurisdiction Liaison.

Submission identifies the product as a combination product.

The combination product contains as a constituent part an approved drug as defined in 21 USC 503(g)(5)(B). 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 applicant will give notice, as applicable. 21 USC 503(g)(5)(A)&(C).

The device has a device-specific guidance document, special controls document, and/or requirements in a device-specific regulation regarding 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 a special controls document or device-specific 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 is no applicable special controls document or device-specific 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.

Device is intended to be marketed with multiple components, accessories, and/or as part of a system.
Select “N/A” if the device is not intended to be marketed with multiple components, 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 components and accessories to be marketed with the subject device.

Submission includes a description (as detailed in item 11a., 11b., and 11d. above) of each component or accessory.
Select “N/A” if the component(s)/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 component or accessory that received a prior 510(k) clearance
AND
A statement is provided that identifies components or 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, regulation number if exempt 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 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” guidance document 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 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.

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

Indications for use are stated in labeling and are identical to Indications for Use form and 510(k) Summary (if 510(k) Summary provided)

Labeling includes:

• Statements of conditions, purposes or uses for which the device is intended (e.g., hazards, warnings, precautions, contraindications) (21 CFR 801.5)

AND

• Includes adequate directions for use (see 21 CFR 801.5)


OR

• Submission states that device qualifies for exemption per 21 CFR 801 Subpart D

Labeling includes name and place of business of the manufacturer, packer, or distributor (21 CFR 801.1)

Labeling includes the prescription statement (see 21 CFR 801.109(b)(1)) or Rx Only symbol (see also Section 502(a) of the FD&C Act and FDA’s guidance “Alternative to Certain Prescription Device Labeling Requirements”).
Select “N/A” if not indicated for prescription use.

The device has a device-specific guidance document, special controls document, and/or requirements in a device-specific regulation regarding labeling 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 labeling 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 labeling information that addresses relevant mitigation measures set forth in a special controls document or device-specific 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 is no applicable special controls document or device-specific 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.

If the device is an in vitro diagnostic device, provided labeling includes all applicable information required per 21 CFR 809.10.
Select “N/A” if not an in vitro diagnostic device.

Sterilization
If an in vitro diagnostic (IVD) device and sterilization is not applicable, select “N/A.” The criteria in this section will be omitted from the checklist if “N/A” is selected.

Submission states that the device, and/or accessories, and/or components are: (one of the below must be checked)

• Provided sterile, intended to be single-use
• Requires processing during its use-life
• Non-sterile when used (and no processing required)
• Information regarding the sterility status of the device is not provided (if this box is checked, please also check one of the two boxes below)
  
  • Sterility status not needed for this device (e.g., software-only device)
  • Sterility status needed or need unclear

• Supplied sterile and requires reprocessing prior to subsequent patient use
• Supplied non-sterile and requires user to process the device for initial use, as well as to reprocess the device after each use
• Reusable medical device (single-user) reprocessed between each use
• Single-use medical devices initially supplied as non-sterile to the user, and requiring the user to process the device prior to its use

Assessment of the need for cleaning and subsequent disinfection or sterilization information.

Identification of device, and/or accessories, and/or components that are provided sterile.
Select “N/A” if no part of the device, accessories, or components is provided sterile.

Identification of device, and/or accessories, and/or components that are end user sterilized or disinfected.
Select “N/A” if no part of the device, accessories, or components is end user sterilized or disinfected.

Identification of device, and/or accessories, and/or components that are reusable.
Select “N/A” if no part of the device, accessories, or components is reusable.

If the device, and/or accessory, and/or a component is provided sterile:
Select “N/A” if no part of the device, accessories, or components is provided sterile, otherwise complete a-f below.

Sterilization method is stated for each component (including dose for radiation sterilization)

A description of method to validate the sterilization parameters is provided for each proposed sterilization method (e.g., half-cycle method and full citation of FDA- recognized standard, including date).
Note: the sterilization validation report is not required.

For devices sterilized using chemical sterilants such as ethylene oxide (EO) and hydrogen peroxide, submission states maximum levels of sterilant residuals remaining on the device and sterilant residual limits.
Select “N/A” if not sterilized using chemical sterilants.

Sterility Assurance Level (SAL) stated

Submission includes description of packaging

For products labeled “non-pyrogenic,” a description of the method used to make the determination stated (e.g., limulus amebocyte lysate [LAL]).
Select “N/A” if not labeled “non-pyrogenic.”

If the device, and/or accessory, and/or a component is reusable or end user sterilized or disinfected:
Select “N/A” if no part of the device, accessories, or components are reusable or end user sterilized or disinfected, otherwise complete a-d below.

Cleaning method is provided in labeling for each device, and/or accessory, and/or component.
Select “N/A” if not reusable and does not need cleaning prior to disinfection or sterilization

Disinfection method is provided in labeling for each device, and/or accessory, and/or component.
Select “N/A” if not disinfected (i.e., undergoes terminal sterilization) prior to use

Sterilization method is provided in labeling for each device and/or accessory, and/or component.
Select “N/A” if not sterilized (i.e., undergoes disinfection) prior to use

Device types in this submission are listed in Appendix E of the FDA’s guidance “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.”
Device types identified in Appendix E of the reprocessing guidance represent devices posing a greater likelihood of microbial transmission and represent a high risk of infection. Select “N/A” if the device type in the submission is not included in Appendix E of the reprocessing guidance.

i)
If device types in this submission are included in Appendix E of the reprocessing guidance, the submission includes protocols and test reports for validating the reprocessing instructions.
Select “N/A” if the device type in the submission is not included in Appendix E of the reprocessing guidance.

The device has a device-specific guidance document, special controls document, and/or requirement in a device-specific regulation regarding sterility and/or reprocessing 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 sterility and/or reprocessing 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 sterility and/or reprocessing information that addresses relevant mitigation measures set forth in a special controls document or device-specific 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 is no applicable special controls document or device-specific 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.

Proposed shelf life/ expiration date stated
OR
Statement that shelf-life is not applicable because of low likelihood of time-dependent product degradation

For a sterile device, submission includes summary of methods used to establish that device packaging will maintain a sterile barrier for the entirety of the proposed shelf-life.
Select “N/A” if the device is not provided sterile.

Submission includes summary of methods used to establish that device performance is maintained for the entirety of the proposed shelf-life (e.g., mechanical properties, coating integrity, pH, osmolality, etc.).
OR
Statement why performance data is not needed to establish maintenance of device performance characteristics over the shelf-life period.

Biocompatibility
If an in vitro diagnostic (IVD) device, select “N/A.” The criteria in this section will be omitted from the checklist if “N/A” is selected.

Submission states that there: (one of the below must be checked)

• Are direct or indirect patient-contacting components
• Are no direct or indirect patient-contacting components
• Information regarding patient contact status of the device is not provided (if this box checked, please also check one of the two boxes below)
  
  • Patient contact information not needed for this device (e.g., software- only device)
  • Patient contact information is needed or need unclear

Submission includes a list identifying each patient-contacting device component (e.g., implant, delivery catheter) and associated materials of construction for each component, including identification of color additives, if present.

Submission identifies contact classification (e.g., surface- contacting, less than 24 hour duration) for each patient- contacting device component (e.g., implant, delivery catheter).

Biocompatibility assessment of patient-contacting components

Submission includes:
Test protocol (including identification and description of test article), methods, pass/fail criteria, and results provided for each completed test.
OR
A statement that biocompatibility testing is not needed with a rationale (e.g., materials and manufacturing/processing are identical to the predicate).

Software

Submission states that the device: (one of the below must be checked)

• Does contain software/firmware
• Does not contain software/firmware
• Information on whether device contains software/firmware is not provided (if this box checked, please also check one of the two boxes below)
  
  • Software/firmware information not needed for this device (e.g., surgical suture, condom)
  • Software/firmware information is needed or need unclear

This information will determine whether and what type of additional information may be necessary for a substantial equivalence determination.
If “does not contain” or “not provided and not needed” is selected, the software-related criteria below are omitted from the checklist. If information on software is not provided, and this information is needed or the need is unclear, select “No.”

Submission includes a statement of software level of concern and rationale for the software level of concern.

All applicable software documentation provided based on level of concern identified by the submitter, as described in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, or the submission includes information to establish that the submitter has otherwise met the applicable statutory or regulatory criteria through an alternative approach (i.e., the submitter has identified an alternate approach with a rationale).
Note: This element is also applicable to non-internally generated or off-the-shelf (OTS) software used in the device

Electrical Safety and EMC

Electrical Safety:
Submission states that the device: (one of the below must be checked)

• Does require electrical safety evaluation
• Does not require electrical safety evaluation
• Information on whether device requires electrical safety evaluation is not provided (if this box checked, please also check one of the two boxes below)
  
  • Electrical safety information not needed for this device (e.g., surgical suture, condom)
  • Electrical safety information needed or need unclear

Submission includes evaluation of electrical safety (e.g., per IEC 60601-1, or equivalent FDA-recognized standard, and if applicable, a device-specific standard).
OR
Submission includes electrical safety evaluation using methods or standards that are not FDA-recognized and submission includes information to establish that the submitter has otherwise met the applicable statutory or regulatory criteria through this alternative approach (i.e., the submitter has identified alternate methods or standards with a rationale).

EMC::
Submission states that the device: (one of the below must be checked)

• Does require EMC evaluation
• Does not require EMC evaluation
• Information on whether device requires EMC evaluation not provided (if this box checked, please also check one of the two boxes below)
  
  • EMC information not needed for this device (e.g., surgical suture, condom)
  • EMC information needed or need unclear

Submission includes evaluation of electromagnetic compatibility (e.g., per IEC 60601-1-2 or equivalent FDA- recognized standard and if applicable, a device-specific standard).
OR
Submission includes electromagnetic compatibility evaluation using methods or standards that are not FDA-recognized and submission includes information to establish that the submitter has otherwise met the applicable statutory or regulatory criteria through this alternative approach (i.e., the submitter has identified alternate methods or standards with a rationale).

Performance Data General
If an in vitro diagnostic (IVD) device, select “N/A.” The criteria in this section will be omitted from the checklist if “N/A” is selected.
Performance data criteria relating to IVD devices is addressed in Section K.

Full test report is provided for each completed test. A full test report includes: objective of the test, description of the test methods and procedures, study endpoint(s), pre- defined pass/fail criteria, results summary, conclusions.
Full test reports provided for all completed tests/evaluations (e.g., bench evaluations, comparative performance tests, etc.). Select “N/A” if the submission does not include performance data.

Submission includes an explanation of how the data generated from each test report supports a finding of substantial equivalence (e.g., comparison to predicate device testing, dimensional analysis, etc.).
Select “N/A” if the submission does not include performance data.

The device has a device-specific guidance document, special controls document, and/or requirement in a device-specific regulation regarding performance data 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 performance data 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 performance data that addresses relevant mitigation measures set forth in a special controls document or device-specific 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 is no applicable special controls document or device-specific 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.

If literature is referenced in the submission, submission includes:
Select “N/A” if the submission does not reference literature. If “N/A”is selected, parts a and b below are omitted from the checklist.
Note that the applicability of the referenced article to support a substantial equivalence finding should be assessed during the substantive review; only the presence of a discussion is required to support acceptance.

Legible reprints or a summary of each article.

Discussion of how each article is applicable to support the substantial equivalence of the subject device to the predicate.

For each completed animal study, the submission provides the following:
Select “N/A” if no animal study was conducted. If “N/A”is selected, parts a-c below are omitted from the checklist. Note that this section does not address biocompatibility evaluations, which are assessed in Section G of the checklist.

Submission includes a study protocol which includes all elements as outlined in 21 CFR 58.120

Submission includes final study report which includes all elements outlined in 21 CFR 58.185

Submission contains a statement that the study was conducted in compliance with applicable requirements in the GLP regulation (21 CFR Part 58), or, if the study was not conducted in compliance with the GLP regulation, the submission explains why the noncompliance would not impact the validity of the study data provided to support a substantial equivalence determination.

Performance Characteristics – In Vitro Diagnostic Devices Only (see also 21 CFR 809.10(b)(12))

Submission indicates that device: (one of the below must be checked)

• Is an in vitro diagnostic device
• Is not an in vitro diagnostic device

Submission includes the following studies, as appropriate for the device type, including associated protocol descriptions, study results and line data:

Precision/reproducibility

Accuracy (includes as appropriate linearity; calibrator or assay traceability; calibrator and/or assay stability protocol and acceptance criteria; assay cut-off; method comparison or comparison to clinical outcome; matrix comparison; and clinical reference range or cutoff.

Sensitivity (detection limits, LoB, LoD, LoQ where relevant for the device type).

Analytical specificity

The device has a device-specific guidance document, special controls document, and/or requirement in a device-specific regulations regarding performance data 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 performance data 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 performance data that addresses relevant mitigation measures set forth in a special controls document or device-specific 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 is no applicable special controls document or device-specific 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.