1、Submission Type
Identification of key information thatmay be useful to FDA in the initial processing and review of the510(k) submission, including content from current Form FDA 3514,Section A.
2、Cover Letter / Letters of Reference
Attach a cover letter and anydocuments that refer to other submissions.
3、Submitter Information
Information on submitter andcorrespondent, if applicable, consistent with content from currentForm FDA 3514, Sections B and C.
4、Pre-Submission Correspondence & Previous RegulatorInteraction
Information on prior submissions forthe same device included in the current submission, such assubmission numbers for a prior not substantially equivalent (NSE)determination, prior deleted or withdrawn 510(k), Q-Submission,Investigational Device Exemption (IDE) application, premarketapproval (PMA) application, humanitarian device exemption (HDE)application, or De Novo classification request.
5、Consensus Standards
Identification of voluntary consensusstandard(s) used, if applicable. This includes both FDA-recognizedand non-recognized consensus standards.
6、Device Description
Identification of listing number iflisted with FDA.
Descriptive information for thedevice, including a description of the technologicalcharacteristics of the device including materials, design, energysource, and other device features, as defined in section513(i)(1)(B) of the FD&C Act and 21 CFR 807.100(b)(2)(ii)(A).Descriptive information also includes a description of theprinciple of operation for achieving the intended effect and theproposed conditions of use, such as surgical technique forimplants; anatomical location of use; user interface; how thedevice interacts with other devices; and/or how the deviceinteracts with the patient.
Information on whether the device isintended to be marketed with accessories.
Identification of any applicabledevice-specific guidance document(s) or special controls for thedevice type as provided in a special controls document (oralternative measures identified that provide at least an equivalentassurance of safety and effectiveness) or in a device-specificclassification regulation, and/or performance standards. See“The 510(k) Program:Evaluating Substantial Equivalence in Premarket Notifications[510(k)].
7、Proposed Indications for Use (Form FDA3881
Identification of the proposedindications for use of the device. The term indications for use, asdefined in 21 CFR 814.20(b)(3)(i), describes the disease orcondition the device will diagnose, treat, prevent, cure, ormitigate, including a description of the patient population forwhich the device is intended.32
8、Classification
Identification of the classificationregulation number that seems most appropriate for the subjectdevice, as applicable
9、Predicates and SubstantialEquivalence34
Identification of a predicate device(e.g., 510(k) number, De Novo number, reclassified PMA number,classification regulation reference, if exempt and limitations toexemption are exceeded, or statement that the predicate is apreamendments device).
The submission should include acomparison of the predicate and subject device and a discussion whyany differences between the subject and predicate do not impactsafety and effectiveness [see section 513(i)(1)(A) of the FD&CAct and 21 CFR 807.87(f)]. A reference device should also beincluded in the discussion, if applicable. See “The 510(k) Program: EvaluatingSubstantial Equivalence in Premarket Notifications[510(k)].”
10、Design/Special Controls, Risks to Health, andMitigation Measures
Applicable to Special 510(k)submissions only.
Identification of the device changesand the risk analysis method(s) used to assess the impact of thechange(s) on the device and the results of the analysis.
Risk control measures to mitigateidentified risks (e.g., labeling, verification). See “The Special 510(k) Program
11、Labeling
Submission of proposed labeling insufficient detail to satisfy the requirements of 21 CFR 807.87(e).Generally, if the device is an in vitro diagnostic device, thelabeling must also satisfy the requirements of 21 CFR 809.10.Additionally, the term “labeling” generally includes the devicelabel, instructions for use, and any patient labeling. See“Guidance on MedicalDevice Patient Labeling.”
12、Reprocessing
Information for assessing thereprocessing validation and labeling, if applicable. See“ReprocessingMedical Devices in Health Care Settings: Validation Methods andLabeling
13、Sterility
Information on sterility andvalidation methods, if applicable. See “Submission and Review of SterilityInformation in Premarket Notification (510(k)) Submissions forDevices Labeled as Sterile
14、Shelf Life
Summary of methods used to establishthat device performance is maintained for the entirety ofthe proposedshelf-life41(e.g., mechanical properties, coating integrity,pH, osmolality), if applicable
15、Biocompatibility
Information on the biocompatibilityassessment of patient contacting materials, if applicable. See“Use ofInternational Standard ISO 10993-1, ‘Biological evaluation ofmedical devices - Part 1: Evaluation and testing within a riskmanagement process.’”
16、Software/Firmware
Submission of applicable softwaredocumentation, if applicable. See “Guidance for the Content of PremarketSubmissions for Software Contained in Medical Devices
17、Cybersecurity/Interoperability
Submission of applicable informationregarding the assessment of cybersecurity, if applicable. See“Content forPremarket Submissions for Management of Cybersecurity in MedicalDevices”44and“DesignConsiderations and Premarket Submission Recommendations forInteroperable Medical Devices
18、Electromagnetic Compatibility (EMC), Electrical,Mechanical, Wireless and Thermal Safety
Submission of the EMC, Electrical,Mechanical, Wireless and Thermal Safety testing for your device orsummarize why testing is not needed. See “Electromagnetic Compatibility (EMC) ofMedical Devices”and“Radio FrequencyWireless Technology in Medical Devices
19、Performance Testing
For non-in vitro diagnostic devices:Provide information on the non-clinical and clinical test reportssubmitted, referenced, or relied on in the 510(k) for adetermination of substantial equivalence. See “Recommended Content and Format ofNon-Clinical Bench Performance Testing Information in PremarketSubmissions.”
20、References
Inclusion of any literaturereferences, if applicable
21、Administrative Documentation
Inclusion of additional administrativeforms applicable to the submission, including but not limited to ageneral summary of submission/executive summary (recommended), aTruthful and Accuracy Statement,49and a 510(k)Summary50or statement
22、Amendment/Additional Information (AI)response
Inclusion of responses to AdditionalInformation requests
