510k submission for Active Device

Statement of Work (SOW)

Phase 1 – Initial Details
Requirements		Scope of I3CGlobal	Scope of 510(k) Applicant
1.	Intended use	Send requisition for Intended use. Identification of product code	Provide an appropriate intended use of the Active device. Confirmation of product code
2.	Indications of Use Statement (Form 3881)	Send requisition for indications for use. Filling out the form based on details provided by the 510(k) applicant. Assist the applicant to frame the appropriate Indications for use statement based on the intended use and product code if required.	Provide appropriate indications for use of the Software device in compliance to intended use. Provide Device Name. Confirm the type of Device i.e., Prescription Use or over the counter Use.
3.	Device Description	Send requisition regarding device description to the applicant through mail communication. Review of device description details shared by applicant. Preparation and documentation of Device Description template as per FDA premarket submission Guidance.	Provide the recommended details of the device which includes: overview of the device its functions and modes, block diagrams photographs, cables, and relevant accessories. device interoperability. a description of the power supply etc
4.	Predicate Device	Identify and share the potential predicate device based on product code and device description.	Approval of a suitable predicate device.
5.	510(K) Summary	Develop a template. Fill the manufacturer and device details. Fills the predicate device details	Provide details regarding the manufacturer- name, address, contact person at the company, contact number etc. Provide details of medical devices like indications of use, the material of construction, any claims, etc.

Phase 2 – Active Device Supporting Documentation based on Indications for Use
Document Requirements		Scope of I3CGlobal	Scope of 510(k) Applicant
2.1	Device Drawing	Send a requisition for a Device Drawing of an Active device. Review and document for 510k submission	Provide device drawing file
2.2	Design and Development of the device	Send requisition for design and development of Active device. Review and document for 510(k) submission.	Provide the design and development file of the Active device.
2.3	Material safety data Sheet	Send a requisition for a Material safety data sheet of crucial components of the Active device. Review and document for 510(k) submission.	Provide Material safety data sheet of crucial components of active device
2.4	Manufacturing Flow chart	Send a requisition for the Manufacturing Flow chart of the active device. Review and document for 510(k) submission.	Provide a Manufacturing Flow chart of the active device.
2.5	Device Description	Send a requisition for device details. Review and document for 510(k) submission	Provide the details including: overview of the device its functions and modes, block diagrams photographs, cables, and relevant accessories. device interoperability. a description of the power supply
2.6	Proposed Labelling	Send a requisition for IFU, User Manual, and Promotional material if any. Review the IFU, User Manual, and promotional material shared by the applicant. Document the IFU, User manual and Promotional material for 510(k) Submission.	Provide IFU, User Manual, and Promotional Material.
2.7	Packaging & Transportation	Send a requisition for Packaging and transportation Validation study plan and reports. Review the packaging and transportation validation study plans and report and share the corrections if any.	Provide packaging and transportation validation study plans and reports.
2.8	Sterilization (If sterility applicable)	Send a requisition for Sterilization Validation and Study plan and reports. Review and document for 510(k) submission	Provide Sterilization Validation and Study plan and reports.
2.9	Performance Testing _ Bench	Send a requisition for performance testing _Bench Study plans and reports of the active device. Review and document for 510(k) submission	Send a requisition for performance testing _Bench Study plans and reports.
Electromagnetic Compatibility and Electrical safety Supporting Documentation
2.10	EMC-Related Device Characteristics and Intended Use Environments	Send requisition for EMC-Related Device Characteristics and Intended Use Environments. Review and document for 510(k) documentation.	• Provide EMC-Related Device Characteristics and Intended Use Environments including: overview of the device its functions and modes, block diagrams photographs, cables, and relevant accessories. device interoperability. a description of the power supply (i.e., mains-powered only, internally powered only, mains and internally powered) including if the internally powered medical device can be used while charging. the environments in which the medical device is intended to be used. a description of any wireless technology (for additional considerations regarding wirelessly enabled medical devices. a description of any internal RF emitters in the medical device that could be sources of EM disturbances. addressing common EM emitters and unique medical emitters
2.11	Risk Assessment	Send a requisition for Risk Management File and Instruct to document the Risk management Plan and Report identifying risk hazards, risk assessment and demonstrating that risks have been appropriately mitigated and risk management report covering all risk elements. If possible, should be provided with separate sections for clear understanding. Provide a template of the Risk management plan and risk management report covering all the device-related risks on request from the applicant. Review the Risk Management File data containing Plan and Report shared by the applicant and suggest the necessary corrections to document for 510(k) submission. Review and document for 510(k) submission.	Provide a Risk management plan, risk assessment demonstrating that risks have been appropriately mitigated and risk management report covering all risk elements. Provide the suggested corrected document.
2.12	Consensus Standard	Send requisition of consensus standards applicable for Active device EMC and electrical safety Document the confirmed Consensus standard for the active device for 510(k) submission.	Provide confirmation of applicable consensus standards and explanation of deviated standards from FDA-recognized standards.
2.13	Essential Performance and Immunity Pass/Fail Criteria	Send requisition for Essential Performance and Immunity tests study plan and reports as per FDA recognized standard for the active device. Review and document for 510(k) submission	Provide Essential Performance and Immunity tests study plan and reports as per FDA-recognized standards for active device
2.14	Medical Device Configuration and Functions Tested	Send requisition for Medical Device Configuration and Functions Tested of the active device. Review and document for 510(k) submission	Provide Medical Device Configuration and Functions Tested of the active device which includes: a detailed description of the medical device under test, including the configuration, functions, modes, and settings tested. description of the device under test should include the medical device name, model number, manufacturer, and an indication of whether the device is the final production-ready medical device currently under review.
2.15	Results of EMC Testing	Send requisition for EMC testing study plan and report as per FDA-recognized consensus standard recommended for active devices. Review and document for 510(k) submission	Provide EMC testing study plan and report as per FDA-recognized consensus standard recommended for the active device.

Phase 3 – Initial Documents and Substantial Equivalence Documents
Document Requirements		Scope of I3CGlobal	Scope of 510(k) Applicant
3.1	CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)	Fill out the FDA Form 3514 based on the details provided by the applicant.	–
3.2	Class III Summary and Certification	Not necessary if clinical studies are not required.	–
3.3	Financial Certification or Disclosure Statement	Not necessary if clinical studies are not required.	–
3.4	Executive Summary	Create a template and prepare the document. Justify any differences between the proposed device and the predicate device. Comparative study between the proposed device and the predicate device is chosen.	–
3.5	Substantial Equivalence Discussion	Create a template and prepare the document. Comparative study between the proposed device and the predicate device is chosen.	–

Phase 4 – Administrative Documents
Document Requirements		Scope of I3CGlobal	Scope of 510(k) Applicant
4.1	510(k) Cover Letter	Prepare and provide a template to the applicant covering all details required for the cover letter and share with the applicant instructing to use the letterhead and provide the authorized person’s signature.	The document printed on company letterhead must be signed and a hard copy couriered to the US office. Provide a Soft copy of signed 510(k) cover letter for 510(k)documentation.
4.2	Truthful and Accuracy Statement	Provide a template with the required content to be mentioned and document for submission.	The document signed by the contact person at the firm should be provided.
4.3	Declarations of conformity and Summary report	Create a template listing and prepare the document.	The document signed by the contact person at the firm should be provided.
4.4	MDFUSC (FDA Form 3601)	Create a medical device user fee cover sheet and PIN.	Make payment to FDA. (Before submission of 510(k) file.)

Phase 5 – RTA Checklist and E-Copy
Document Requirements		Scope of I3CGlobal	Scope of 510(k) Applicant
5.1	RTA Checklist	Create an RTA Checklist Template based on the type of submission. Fill out the checklist and ensure that mentioned documents are submitted to the FDA and shared with the applicant.	Approval of Verification of RTA Checklist.
5.2	E-Copy	Arrangement of submission folder sections as per FDA Guidance and share to the applicant. Convert to e-copy. E-copy submission to US Agent	Approval of Final submission Folder documentation.