Statement of Work (SOW) for Active Medical Device and Non-Active Medical Device 510(K) Submission

Banner with Title

Overview

Statement of Work (SOW) for Active Medical Device and Non-Active Medical Device 510(K) Submission Overview

At Freyr, our expert team diligently compiles and distills the latest information essential for your 510(K) submissions, encompassing both active and Non-active medical devices. This ensures you possess the requisite knowledge to confidently navigate the regulatory framework. From clarifying the contrasts between active and non-active devices to delving into the intricacies of the 510(K) submission, we have curated an extensive repository of resources for your primary reference. Embark on a journey towards mastering the Active medical device 510(K) submission and Non-active medical devices 510(K) submission with our all-inclusive guide.

Phase -1 Initial Details
Requirements	Scope of 510(k) Applicant	Scope of Freyr
Intended use	Provide a clear and acceptable intended use for the Active and Non-active medical device 510(K) submission. Evaluate the product code.	Send requisition for Intended use. Identification of product code.
Indications of Use Statement (Form3881)	Provide appropriate indications for the use of the device in compliance with the intended use Provide Device Name. Confirm whether the device is for Prescription Use or over-the-counter Use.	Send requisition for indications for use. Fill out the form based on details provided by the 510(k) applicant. Assist the applicant in framing the appropriate Indications for use statement based on the intended use and product code if necessary.
Device Description	Provide the recommended details of the device, including: o Overview of the device o Its functions and modes, block diagrams o Images, schematic representation, and relevant accessories, material safety data, o Software/Firmware o Device interoperability. o A description of the power supply etc	Send requisition regarding device description to the applicant through email. Review the device description details shared by the applicant. Drafting the device description that aligns with the premarket submission guidelines referring to the eSTAR content of the FDA
Standards and Guidance	Provide device-specific guidance and applicable Standards with FDA recognition number (if any) for Consensus Standards.	Review the applicable Standards and FDA guidance including device-specific/Special Control guidance for the proposed device.
Predicate Device	Acknowledgment and review the appropriate predicate device.	Identify a suitable predicate device with reference to the same Product Code and Regulation number/name for the subject device. Substantial equivalence analysis of Predicate device comparison with subject device based on similarities/differences in Indication for use, technological characteristics, device functions, specifications, etc.,
510(K) Summary	Furnish comprehensive manufacturer information, including the name, address, designated contact person within the company, and relevant contact details such as phone number. Present comprehensive details regarding the medical devices, including indications of use, construction materials, and any associated claims or specifications.	Create a standardized template. Populate the template with accurate manufacturer and device details. Complete the template by entering the necessary predicate device information

Phase 2: Supporting Documentation based on Indications for Use
Document Requirements		Scope of 510(k) Applicant	Scope of Freyr
2.1	Device Drawing	Submit the device drawing file to ensure an accurate representation of the device's design	Initiate a formal request for a Device Drawing of an Active device. Thoroughly review and meticulously document the necessary information for 510(k) submission.
2.2	Design and Development of the device	Submit the design and development file of the Active device, encompassing all relevant information and documentation.	Submit a request for the design and development of an active device. Thoroughly review and meticulously document all necessary information in preparation for the 510(k) submission.
2.3	Material safety data Sheet	Furnish the Material Safety Data Sheets (MSDS) for the essential components of the active device, ensuring comprehensive information regarding their safety and composition	Send a requisition for a Material safety data sheet of crucial components of the Active device. Thoroughly review and meticulously document all necessary information in preparation for the 510(k) submission.
2.4	Manufacturing Flow chart	Supply a Manufacturing Flow Chart detailing the production process of the active device, providing a visual representation of the manufacturing steps and their sequence	Submit a request for the Material Safety Data Sheet (MSDS) of essential components for the Active device. Thoroughly review and meticulously document all necessary information in preparation for the 510(k) submission.
2.5	Device Description	Provide comprehensive details including: o An overview of the device o Functions and operating modes o Block diagrams o Photographs, cables, and relevant accessories o Device interoperability. o Description of the power supplyTop of Form	Submit a request for detailed information about the device. Thoroughly review and meticulously document all necessary information in preparation for the 510(k) submission.
2.6	Proposed Labelling	Provide the Instructions for Use (IFU), User Manual, and any associated promotional material for the active device.	Submit a request for the Instructions for Use (IFU), User Manual, and any promotional material, if available. Review the IFU, User Manual, and promotional material provided by the applicant. Document the IFU, User Manual, and Promotional material for the purpose of 510(k) Submission.
2.7	Packaging & Transportation	Provide the study plans and reports for the packaging and transportation validation.	Submit a request for the study plan and reports regarding Packaging and Transportation Validation. Review the study plans and reports for Packaging and Transportation Validation and provide any necessary corrections or feedback.
2.8	Sterilization (If sterility applicable)	Provide the study plans and reports for Sterilization Validation.	Submit a requisition for the Sterilization Validation study plan and reports. Thoroughly review and meticulously document all necessary information in preparation for the 510(k) submission.
2.9	Performance Testing _ Bench	Initiate a formal request for the performance testing Bench Study plans and reports, outlining the specific requirements and objectives to be addressed	Submit a requisition for the Bench Study plans and reports of the active device for performance testing. Thoroughly review and meticulously document all necessary information in preparation for the 510(k) submission.
Electromagnetic Compatibility and Electrical Safety Supporting Documentation
2.10	EMC-Related Device Characteristics and Intended Use Environments	Provide details on EMC-Related Device Characteristics and Intended Use Environments, including: o An overview of the device. o Functions and operating modes. o Block diagrams. o Photographs, cables, and relevant accessories. o Device interoperability. o Description of the power supply, including the feasibility of using the internally powered medical device while charging. o Environments in which the medical device is intended to be used. o Description of any wireless technology (if applicable) for additional considerations regarding wireless-enabled medical devices. o Description of any internal RF emitters in the medical device that could potentially cause electromagnetic disturbances. o Addressing common electromagnetic (EM) emitters as well as unique medical emitters.	Submit a requisition for information regarding EMC-related device characteristics and intended use environments. Thoroughly review and meticulously document all necessary information in preparation for the 510(k) submission.
2.11	Risk Assessment	Supply a Risk Management Plan that includes a risk assessment showcasing effective risk mitigation, along with a comprehensive risk management report encompassing all risk elements. Furnish the revised document with suggested corrections and improvements	Submit a requisition for the Risk Management File and request documentation of the Risk Management Plan and Report, including the identification of risk hazards, risk assessment, and demonstration of appropriate risk mitigation. The Risk Management Report should cover all risk elements, preferably with separate sections for clarity. Provide a template of the Risk Management Plan and Risk Management Report that encompasses all device-related risks upon request from the applicant. Review the data in the Risk Management File, including the Plan and Report shared by the applicant, and provide suggestions for necessary corrections to ensure comprehensive documentation for 510(k) submission. Thoroughly review and meticulously document all necessary information in preparation for the 510(k) submission.
2.12	Consensus Standard	Provide confirmation of the relevant consensus standards and an explanation of any deviations from FDA-recognized standards.	Submit a requisition for the applicable consensus standards related to EMC and electrical safety for the Active device. Document the confirmed consensus standards for the active device for the purpose of 510(k) submission.
2.13	Essential Performance and Immunity Pass/Fail Criteria	Submit the study plan and reports for Essential Performance and Immunity tests conducted on the active device, adhering to FDA-recognized standards.	Submit a requisition for the study plan and reports of Essential Performance and Immunity tests conducted on the active device, in accordance with FDA-recognized standards. Thoroughly review and meticulously document all necessary information in preparation for the 510(k) submission.
2.14	Medical Device Configuration and Functions Tested	Furnish the Medical Device Configuration and Functions Tested for the active device, encompassing the following details: o Provide a comprehensive description of the medical device under test, including detailed information about its configuration, functions, modes, and the specific settings that were tested. o The description of the device under test should encompass the medical device name, model number, and indicate whether the device is the final production-ready medical device currently under review.	Submit a request for the configuration and test functions of the active medical device. Thoroughly review and meticulously document all necessary information in preparation for the 510(k) submission.
2.15	Results of EMC Testing	Supply the EMC (Electromagnetic Compatibility) testing study plan and report in accordance with the FDA-recognized consensus standard recommended for the active device.	Initiate a formal request for the EMC testing study plan and report, aligned with the FDA-recognized consensus standard recommended for active devices. Thoroughly review and meticulously document all necessary information in preparation for the 510(k) submission.

Phase 3 – Initial Documents and Substantial Equivalence Documents
Document Requirements		Scope of 510(k) Applicant	Scope of Freyr
3.1	CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)	-	Complete the FDA Form 3514 using the details provided by the applicant
3.2	Class III Summary and Certification	-	This step is not necessary if clinical studies are not required
3.3	Financial Certification or Disclosure Statement	-	This step is not necessary if clinical studies are not required
3.4	Executive Summary	-	Develop a template and meticulously prepare the document. Provide justifications for any discrepancies observed between the proposed device and the predicate device. Comparative study between the proposed device and the predicate device is chosen, create a template and prepare the corresponding document.
3.5	Substantial Equivalence Discussion	-	Develop a template and meticulously prepare the document. Comparative study between the proposed device and the predicate device is chosen, create a template and prepare the corresponding document.

Phase 4 – Administrative Documents
Document Requirements		Scope of 510(k) Applicant	Scope of Freyr
4.1	510(k) Cover Letter	Sign the document printed on company letterhead and arrange for a hard copy to be couriered to the US office. Provide a digital copy of the signed 510(k) cover letter for inclusion in the 510(k) documentation	Prepare a comprehensive template encompassing all the necessary details for the cover letter and provide it to the applicant. Instruct the applicant to use their official letterhead and ensure that the cover letter is signed by an authorized person
4.2	Truthful and Accuracy Statement	Ensure that the document is signed by the designated contact person at the firm and provided accordingly.	Develop a comprehensive template containing all the necessary content to be included in the submission document.
4.3	Declarations of conformity and Summary report	Ensure that the document is signed by the designated contact person at the firm and provided accordingly.	Develop a comprehensive template to systematically list and prepare the required documents.
4.4	MDFUSC (FDA Form 3601)	Submit the required payment to the FDA prior to the formal submission of the 510(k) file	Generate a user fee cover sheet and a unique Personal Identification Number (PIN) specifically for the medical device submission.

Phase 5 – RTA Checklist and E-Copy
Document Requirements		Scope of 510(k) Applicant	Scope of Freyr
5.1	RTA Checklist	Approval for the Verification of RTA (Ready to Accept) Checklist, indicating that all requirements have been successfully met	Develop a customized RTA Checklist Template tailored to the specific type of submission. Complete the checklist by meticulously filling out all required fields and ensuring that the mentioned documents are duly submitted to the FDA and shared with the applicant.
5.2	E-Copy	Approval for the documentation contained within the Final Submission Folder, signifying its compliance with all necessary requirements and standards.	Organize the submission folder sections in accordance with FDA Guidance and promptly share them with the applicant. Convert the submission folder into an electronic copy for convenient access and review. Submit the electronic copy of the submission to the designated US Agent.

Freyr Expertise and Advantages

Expertise

Freyr Expertise

Comprehensive US FDA Regulatory strategy
Predicate Device Identification
Establishing Substantial Equivalence with Predicate Device
Gap Analysis for US FDA Compliance
Compilation of 21 sections of 510(k) Technical File
Publishing and creation of eCopy
Validation and submission of eCopy
Liaising services for Device Approval
Addressal of RTA response and deficiencies
Consultation services for addressing deficiencies
Device Listing & FURLS database maintenance

Advantages

Freyr Advantages

Have handled many 510(k) registrations of diversified device categories
Expert team for 510(k) compilation as per US FDA Premarket Notification (510(k)) requirements
Additional support to handle 510(k) queries
Advice for the suitable type of 510(k) as per US FDA 510(k) submission requirements for the device
On-time submission of deliverables
Up to date with US FDA new amendments

Statement of Work (SOW) for Active Medical Device and Non-Active Medical Device 510(K) Submission