Status of Guidance:
Final
Final
Name of Organization:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Date of Guidance:
October 2004
October 2004
Target Audience:
Medical device manufacturers and clinical trial investigators testing materials to be injected into the spine to stabilize broken vertebrae.
Medical device manufacturers and clinical trial investigators testing materials to be injected into the spine to stabilize broken vertebrae.
Laws and Regulations Referenced:
21 CFR 812.3(d): Defines “implant” as a device that remains in the body for more than 30 days.
21 CFR 812.25(e): Defines “monitoring procedures” as they relate to the testing of medical devices.
21 CFR 820.30(g): Defines “design validation” process for ensuring that a medical device meets patient needs.
21 CFR 888.3027: Classifies polymethylmethacrylate (PMMA) bone cement as a Class II medical device under the FDA’s classification system.
21 CFR 888.3050: Classifies spinal interlaminal fixation orthoses as Class II medical devices under the FDA’s classification system.
21 CFR 888.3060: Classifies spinal intervertebral body fixation orthoses as Class II medical devices under the FDA’s classification system.
21 CFR 888.3070: Classifies pedicle screw spinal systems as either Class II or Class III medical devices under the FDA’s classification system, depending on nature of clinical use.
21 CFR 812.3(d): Defines “implant” as a device that remains in the body for more than 30 days.
21 CFR 812.25(e): Defines “monitoring procedures” as they relate to the testing of medical devices.
21 CFR 820.30(g): Defines “design validation” process for ensuring that a medical device meets patient needs.
21 CFR 888.3027: Classifies polymethylmethacrylate (PMMA) bone cement as a Class II medical device under the FDA’s classification system.
21 CFR 888.3050: Classifies spinal interlaminal fixation orthoses as Class II medical devices under the FDA’s classification system.
21 CFR 888.3060: Classifies spinal intervertebral body fixation orthoses as Class II medical devices under the FDA’s classification system.
21 CFR 888.3070: Classifies pedicle screw spinal systems as either Class II or Class III medical devices under the FDA’s classification system, depending on nature of clinical use.
Definitions:
Vertebral augmentation device: Material, such as bone cement, injected into the spine to provide stability after a fracture.
Spinal insufficiency fracture: A break in a vertebra (bone of the spine), which may be caused by minor injury, osteoporosis, or other conditions.
Osteoporosis: Weakening of the bones, which occurs with aging.
Vertebroplasty: A surgical procedure in which material (such as bone cement) is injected into a broken vertebra to stabilize it.
Kyphoplasty: A surgical procedure in which material (such as bone cement) is injected into a broken vertebra to stabilize it, after an instrument is used to return the bones to their original shape.
Background:
A spine that is weakened by osteoporosis, minor injury, or other medical condition, may develop small fractures or breaks. When these breaks cannot be treated by physical therapy, medication, or a brace, they may require surgery. Surgery involves injecting bone cement or similar material into the broken vertebra to help stabilize it and relieve pain. The materials used for this are referred to as “devices” because they stay in the body over the long term. The FDA categorizes them as Class II medical devices under their classification system, meaning they pose moderate risk to the patient, and may require testing in humans before they are approved for use. This guidance outlines areas that a device manufacturer or researcher designing testing should consider when studying the safety and efficacy of these materials.
A spine that is weakened by osteoporosis, minor injury, or other medical condition, may develop small fractures or breaks. When these breaks cannot be treated by physical therapy, medication, or a brace, they may require surgery. Surgery involves injecting bone cement or similar material into the broken vertebra to help stabilize it and relieve pain. The materials used for this are referred to as “devices” because they stay in the body over the long term. The FDA categorizes them as Class II medical devices under their classification system, meaning they pose moderate risk to the patient, and may require testing in humans before they are approved for use. This guidance outlines areas that a device manufacturer or researcher designing testing should consider when studying the safety and efficacy of these materials.
Summary:
When applying for approval of a new type of vertebral augmentation device for the treatment of spinal insufficiency fractures, the FDA may require testing in humans. This typically happens when the material is substantially different than any currently approved materials. New types of plastic are continually being developed, some of which may be absorbed by the body over time after the spinal fracture has healed. These newer materials must be tested for safety and effectiveness in humans before the FDA can approve them.
When applying for approval of a new type of vertebral augmentation device for the treatment of spinal insufficiency fractures, the FDA may require testing in humans. This typically happens when the material is substantially different than any currently approved materials. New types of plastic are continually being developed, some of which may be absorbed by the body over time after the spinal fracture has healed. These newer materials must be tested for safety and effectiveness in humans before the FDA can approve them.
Spinal insufficiency fractures are usually treated first with physical therapy, bracing, or medication, or a combination of these. If these treatments do not relieve the patient’s pain after 8 weeks, surgery may be recommended. Two types of surgery are used. The first, vertebroplasty, involves injecting bone cement or similar material into the broken vertebra. The second, kyphoplasty, first manipulates the bones with instruments to return them to their original shape before injecting the bone cement.
When designing a study of these devices, the FDA recommends the use of a control group to compare with the group of patients treated with the new device. A control group may be treated with an FDA-approved device, or may receive physical therapy, medication and bracing, or a sham procedure. The use of a sham procedure, in which the patient undergoes surgery without knowing it is a placebo or simply an injection of pain medication, raises ethical issues and is appropriate in very few cases. Patients who undergo a sham procedure or any other control treatment are typically offered the actual treatment at a later date.
The guidance recommends certain criteria for including or excluding patients from the study. These involve the severity of the spinal fracture, how many vertebrae are involved, the severity of pain and limitation of movement, patient age and other medical conditions, the health of the tissue surrounding the fracture, the curvature of the spine, allergies, pregnancy, heart problems, and neurological conditions.
The FDA recommends following up with patients over the course of 2 years after treatment to determine how well the device works over the long term. The success of the device is determined primarily by reduction in pain and increase in functional abilities.
The safety of the device should be measured by the rate of infection following the procedure, the need for additional surgeries, and any unwanted side effects. X-rays should show that the injected material has not moved out of place. Other safety concerns include additional fractures above or below the original and arthritis in the spine.
Certain risks are known to exist in patients requiring vertebral augmentation. They include heart attack, low blood pressure, breathing problems, infections, blood in the urine, uncontrolled bleeding, pain, numbness, bone fracture, pneumonia, rib fracture, leg pain, and stroke. The device maker should consider these risks when developing a risk analysis.
All studies of vertebral augmentation devices should be monitored by qualified experts to make sure the studies are conducted according to plan and that records are kept accurately.
Rationale:
Vertebral augmentation devices pose specific known risks and their testing should be designed with these risks in mind. As newer materials are developed to treat spinal insufficiency fractures, it is important for device makers and investigators to perform ethically and scientifically sound studies of safety and efficacy in humans.
Vertebral augmentation devices pose specific known risks and their testing should be designed with these risks in mind. As newer materials are developed to treat spinal insufficiency fractures, it is important for device makers and investigators to perform ethically and scientifically sound studies of safety and efficacy in humans.
Resulting Recommendations:
· If a material is substantially different from those previously approved by the FDA to treat spinal insufficiency fractures, it may require testing in humans.
· Testing of spinal augmentation devices should include a control group for comparison. The control group may receive physical therapy, medication, bracing, or a sham treatment.
· Patients should be evaluated for inclusion or exclusion based on factors such as fracture location, age, other medical conditions, number of fractures, pain, functional limitation, spinal instability, spinal curvature, pregnancy, heart or lung problems, infection, and allergies.
· Patients should receive 8 weeks or more of conservative treatment prior to evaluation for surgery.
· Patients should be followed up for at least 2 years.
· Determination of device effectiveness should be based on reduction in pain and restoration of function.
· Determination of device safety should be based on rates of infection and reoperation, neurological problems, additional spinal fractures, arthritis in the spine, and other serious side effects.
· A thorough risk analysis should be made, which considers, among other factors, cardiac problems, breathing complications, urinary problems, bleeding disorders, infections, neurological problems, pneumonia, rib fractures, leg pain, and stroke.
Impact:
This guidance helps the developers of spinal augmentation devices to design studies that thoroughly test the safety and efficacy of new materials, while minimizing the risks to patients. By following the recommendations in this guidance, a device maker is more likely to gain FDA approval by addressing all safety and efficacy concerns, which may result in the earliest possible access to the latest treatments for patients in the US.
This guidance helps the developers of spinal augmentation devices to design studies that thoroughly test the safety and efficacy of new materials, while minimizing the risks to patients. By following the recommendations in this guidance, a device maker is more likely to gain FDA approval by addressing all safety and efficacy concerns, which may result in the earliest possible access to the latest treatments for patients in the US.
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