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Testing Your Device: What the FDA Looks For. Confidential Vice President, Regulatory and Clinical Affairs Graduated Tulane University in Biomedical Engineering;

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Presentation on theme: "Testing Your Device: What the FDA Looks For. Confidential Vice President, Regulatory and Clinical Affairs Graduated Tulane University in Biomedical Engineering;"— Presentation transcript:

1 Testing Your Device: What the FDA Looks For

2 Confidential Vice President, Regulatory and Clinical Affairs Graduated Tulane University in Biomedical Engineering; MS in Bioengineering Clemson Develop comprehensive regulatory strategies for complex musculoskeletal devices and biologics Review and write regulatory submissions (510(k)s, IDEs, PMAs) for orthopedic, spinal, and biological companies across the world Design and implement mechanical, biomechanical, and animal testing and clinical study strategy and initiation for orthopedic and spinal companies Former Branch Chief, Orthopedic Devices Branch, DSORD, CDRH Former Spine Team Leader, DSORD, CDRH Developed and/or reviewed over 1,000 submissions MCRA Current Consultant to 200 Companies Founded February 25, Employees and Independent Experts Offices in Washington, DC  New York  Connecticut B IO Integrated Services: US & International Regulatory, Reimbursement, Compliance, Clinical Services  Quality Assurance

3 Demonstration of substantial equivalence of your device to a valid predicate –What’s a valid predicate? A spinal system that is currently being used in the same fashion (intended use) for the same indications –Need to demonstrate equivalency in design and performance Examples: material, mechanical characteristics, mechanism of action, sizes, sterilization, labeling If “significant” difference, burden on company to demonstrate the risks of the differences can be mitigated. –Need to focus on stiffness, yield load, ultimate load, and failure mode May need to have side by side testing –Have to demonstrate substantial equivalence in 2 cycles “3 Strikes and you’re out” (original submission + 2 responses) Background 510(k) Concept

4 When developing testing protocol and plan, consider: Case Material Worst Case Size Other Worst Case Considerations Design Features Mechanism of Action Failure Modes Wear Capabilities Non-Standardized Testing Demonstrating Substantial Equivalence Demonstrating Mechanical Equivalence Points to Consider

5 Test the worst case material for each test What does that mean? Weakest material – Polymer versus Metal Depends on the test! –Higher stiffness but lower yield? –Higher yield due to lower stiffness? Most devices use same material; so material selection not common Test the worst case size for each test What does that mean? Smallest size usually worst case Depends on the test –FDA: Tall device for torsion vs smallest footprint for compression –FEA becoming more popular: Taller devices can have more holes/visualization windows, confounds basic mechanics Interbody Cage: Dual cages or single cage? Materials & Sizes What the FDA Looks for

6 Other Considerations Sterilization Device must be fully sterilized If different sterilization processes used, which process is more- worst case? FDA very sensitive to gamma sterilization of polymers Laser Marking Demonstrate laser marking does not affect performance Size vs. Indication AIS indications: pediatric population Larger screws too big for anatomy Small screws too small for skeletally mature Coatings HA on polymer? Porous coating on metal? Nitinol? What the FDA Looks for

7 Design Features Constructs (ASTM F1717) Standard 76mm length for pedicle screw systems Does system include offset connector? Transverse connector? Cages (ASTM F2077) FEA more common to identify worst-case Basic mechanics less reliable to predict worst-case height due to holes Anterior Cervical Plates (ASTM F1717) Screw back-out prevention TDRs (ASTM F2423) Design dependent, but smallest insert or size usually worst-case OCT (ASTM F2706) Plate, hooks, screws? What the FDA Looks for Justify All Testing, Sizes, and Constructs

8 Mechanism of Action What the FDA Looks For Characterize how the device works Testing must be compared to predicate device with same indications and intended use How does the device stabilize the spine? Interbody Screws Blades Nothing Interspinous Anterior/Posterior Just because in same anatomical location, the treatment effect difference Example: Interspinous Devices can not be compared to pedicle screws Example: Interbody cage with screws compared to interbody cage w/no screws

9 Failure Modes What the FDA Looks For Characterize how the device breaks/fails Demonstrating better results not good enough Began with Dynamic Stabilization Devices FDA expects failure modes to be identical to predicate devices Common failure modes Screw breakage Rod bending Cage cracking “Bone” fracture New failure mode? Usually due to novel design feature or material Company must present risk assessment proactively FDA may request clinical data

10 Wear Considerations What the FDA Looks For When is wear data needed? Articulating devices or mixed-material devices Example: Cages with screws Titanium alloy screws interfaced with PEEK cage Wear in compression, torsion, compression-shear TDRs Usually softer articulating surface (e.g., PE on metal) wears Standards dictate tested wear pattern Metal on metal? Must address wear specific to the tested material Has to be same material Limited published data to address wear safety If no public information available, rabbit neurotoxicity study with same wear particulate needed

11 Non-standardized testing What the FDA Looks For Purpose Substantial Equivalence? Safety? Testing for a 510(k) Non-standard testing requires predicate to be tested side-by-side Or ability to recreate “unique” testing with reference to results Occasionally, FDA asks for specific test to address specific issue Bottom-line: Need for non-standardized testing = difficult SE argument Testing for an IDE Need to demonstrate safety Non-standard testing more prevalent since standards don’t exist yet for newer devices (e.g., interspinous process devices) Must justify test set-up, protocol, results based on worst-case expected, clinically relevant loading/motion

12 Demonstrating Substantial Equivalence What the FDA Looks For FDA’s Questions: Is there a valid predicate? Does predicate have same indications and intended use? How does the design compare to the predicate? How does the device perform compared to the predicate? Was standard method used? If deviations, how does it affect results and comparisons Was worst-case device tested? Mechanical results comparison to predicate a MUST Reviewers tend not make comparisons on their own Seek Assistance Because Setting a Bad Precedent Could Kill a Submission

13 Thank you


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