Noha Ahmed
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how to prepare bone plates and screws technical file for approval for FDA
FDA medical devices
- Thread starter Noha Ahmed
- Start date
Lynne
Registered
In order to prepare technical file for orthopedic bone plates and screws for FDA approval, there are a number of detailed steps to follow and multiple aspects to consider.
1. Be familar with the FDA's regulatory requirements and guidance documents:
The first step is to ensure an in-depth understanding of the FDA's regulatory requirements for bone plates and screws. Guidance documents issued by the FDA, such as "Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions," provide manufacturers with key points to consider when preparing submissions.
2. Prepare technical documentation:
Device description: provide a detailed description of the bone plate and screws, including representative images or photographs of the components, the anatomic site used, the material, and any standards the material meets. For bone plates, specific information such as plate shape, number of holes, hole diameter, and locking mechanism is also required. For screws, details such as screw type, range of lengths, range of threaded areas, etc. are required.
Intended use: Clearly state the intended use and target population of the bone plate and screw.
Sterile/non-sterile status: state whether the product is sterile or non-sterile, and if sterile, the sterilization method and expiration date.
Packaging information.
Reprocessable Information (if applicable): Include cleaning instructions.
3. Follow FDA submission formats and guidelines:
Ensure that the submission meets FDA's format and guidance requirements, including using appropriate forms and providing necessary information.
4. Consider safety- and performance-based pathways:
In accordance with the guidance issued by FDA on "Fracture Fixation Plates-Performance Standards for the Safety- and Performance-Based Pathway," an applicant may choose to use the safety- and performance-based pathway to demonstrate that a new device is equivalent in safety and effectiveness to a device that is already legally marketed. This may require demonstrating that the new device meets the performance standards established by the FDA.
5. Prepare other necessary documentation and information:
Depending on the FDA's requirements, other documents and information may be required, such as a description of the manufacturing process, quality control measures, and biocompatibility assessment.
6. Submit 510(k) application:
After preparing all necessary documents and information, submit the 510(k) application through FDA's electronic submission system.
1. Be familar with the FDA's regulatory requirements and guidance documents:
The first step is to ensure an in-depth understanding of the FDA's regulatory requirements for bone plates and screws. Guidance documents issued by the FDA, such as "Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions," provide manufacturers with key points to consider when preparing submissions.
2. Prepare technical documentation:
Device description: provide a detailed description of the bone plate and screws, including representative images or photographs of the components, the anatomic site used, the material, and any standards the material meets. For bone plates, specific information such as plate shape, number of holes, hole diameter, and locking mechanism is also required. For screws, details such as screw type, range of lengths, range of threaded areas, etc. are required.
Intended use: Clearly state the intended use and target population of the bone plate and screw.
Sterile/non-sterile status: state whether the product is sterile or non-sterile, and if sterile, the sterilization method and expiration date.
Packaging information.
Reprocessable Information (if applicable): Include cleaning instructions.
3. Follow FDA submission formats and guidelines:
Ensure that the submission meets FDA's format and guidance requirements, including using appropriate forms and providing necessary information.
4. Consider safety- and performance-based pathways:
In accordance with the guidance issued by FDA on "Fracture Fixation Plates-Performance Standards for the Safety- and Performance-Based Pathway," an applicant may choose to use the safety- and performance-based pathway to demonstrate that a new device is equivalent in safety and effectiveness to a device that is already legally marketed. This may require demonstrating that the new device meets the performance standards established by the FDA.
5. Prepare other necessary documentation and information:
Depending on the FDA's requirements, other documents and information may be required, such as a description of the manufacturing process, quality control measures, and biocompatibility assessment.
6. Submit 510(k) application:
After preparing all necessary documents and information, submit the 510(k) application through FDA's electronic submission system.
