FDA Performance Testing Requirements: Complete Bench, Software, and Biocompatibility Guide
- Beng Ee Lim
- Dec 19, 2025
- 14 min read
FDA expects performance testing that demonstrates your device functions as intended and does not raise different questions of safety or effectiveness compared to your predicate. The scope of testing depends on device type, risk, and technological differences, but most 510(k)s include bench or performance testing, software validation where applicable, and biocompatibility assessment for patient-contacting components. This guide shows you exactly which tests FDA requires for your specific device type, how to determine test methods that FDA will accept, and how to avoid the expensive retesting trap.
The Testing Decision Framework: What Do You Actually Need?
FDA does not publish a universal testing checklist. Performance testing expectations are risk-based and depend on your device’s intended use, technological characteristics, and how it compares to the predicate device. This framework helps determine what FDA is likely to expect.
Question 1: Does Your Predicate’s 510(k) Describe Testing?
Start with the predicate’s publicly available 510(k) summary, typically under sections like “Performance Testing” or “Non-Clinical Testing.”
If the predicate lists specific tests, FDA generally expects you to:
Address the same testing areas, and
Use the same or scientifically justified equivalent methods, and
Demonstrate comparable performance relative to the predicate
If the summary is vague or incomplete:
Review similar devices in the same classification
Consider requesting the full submission through FOIA (which can take weeks to months)
Use a Pre-Submission meeting to clarify FDA’s expectations
Illustrative example (infusion pump): Predicate testing may include flow accuracy, occlusion pressure, alarm performance, electrical safety, and EMC testing. FDA would typically expect you to address these areas unless you can justify why a specific test does not apply.
This is where teams often lose time. Mapping predicate tests directly to your own test plan in a comparison table helps ensure nothing is missed and makes FDA review easier.
Question 2: Are There Technological Differences From the Predicate?
For each technological difference, FDA expects you to explain how it is addressed.
Key questions:
Does the difference affect safety or effectiveness?
How is that risk evaluated or mitigated?
What evidence supports equivalence?
Not every difference requires new testing, but every difference must be addressed, often through testing, analysis, or both.
Examples:
Material change: May require strength testing, corrosion analysis, and biocompatibility evaluation depending on contact type
Added software or connectivity: May require software validation, cybersecurity assessment, and wireless coexistence testing
In practice, teams benefit from linking each technological difference directly to supporting test evidence. Complizen’s comparison tables help map device-to-predicate differences to specific tests and analyses, reducing gaps that trigger AI requests.
Question 3: Does FDA Guidance Specify Expectations?
Search for device-specific FDA guidance and special controls related to your classification.
If guidance exists, FDA generally expects submissions to align with the testing described, or clearly justify any deviations. Guidance often references recognized consensus standards (ISO, IEC, ASTM) that FDA reviewers rely on.
Example: For continuous glucose monitoring systems, FDA guidance highlights expectations around accuracy, interference testing, user performance, and software validation beyond basic bench testing.
If no guidance exists, FDA typically looks to recognized standards and a well-documented risk-based rationale.
Question 4: What Is Your Device Classification?
Class I (often 510(k)-exempt): Testing is still expected to support basic safety and performance, depending on risk.
Class II (most 510(k)s): Non-clinical performance testing is usually required to demonstrate substantial equivalence and meet any applicable special controls.
Class III (PMA): Requires extensive non-clinical and often clinical evidence and is beyond the scope of this guide.
The Reviewer’s Core Question
Across all device types, FDA is ultimately asking:
Have you provided sufficient evidence to show that any differences from the predicate do not raise different questions of safety or effectiveness?
Structuring your testing strategy around that question, and clearly linking differences to data, is what prevents rework and delays.
Performance and Bench Testing: Proving Your Device Works
Performance testing provides objective evidence that your device meets its design specifications and does not raise different questions of safety or effectiveness compared to the predicate device.
The exact tests FDA expects depend on device type, intended use, and technological characteristics.
Representative Performance Testing by Device Category
Mechanical and Implantable Devices
Common testing areas may include:
Dimensional verification and tolerances
Mechanical strength and fatigue
Wear and durability under simulated use
Corrosion resistance for metallic components
Example (orthopedic fixation): Testing often evaluates axial strength, torsional performance, and cyclic loading using applicable ASTM standards, with test parameters selected to reflect clinical use.
Fluid Management Devices
Testing may address:
Flow rate accuracy across operating range
Pressure resistance and leak integrity
Occlusion detection or response behavior
Example (IV catheter or pump): Flow performance and kink resistance are commonly evaluated under representative pressure and orientation conditions.
Diagnostic Devices
Performance testing typically includes:
Analytical sensitivity and specificity
Precision and repeatability
Accuracy relative to a reference method
Environmental and interferent testing
Example (blood glucose monitoring): Accuracy and precision testing is often aligned with the applicable version of ISO 15197, along with evaluation of common interferents and environmental conditions.
Surgical Instruments
Testing may include:
Functional performance (cutting, clamping, actuation)
Reprocessing and durability for reusable devices
Compatibility with sterilization cycles
Comparative Performance Testing: You vs. the Predicate
When technological characteristics differ, FDA often expects comparative performance data demonstrating that your device performs comparably to the predicate.
A typical approach includes:
Identifying relevant predicate specifications
Using the same or scientifically justified equivalent test methods
Testing both devices under identical conditions
Comparing results using predefined acceptance criteria
This is where many submissions fail quietly. Without a clear device-to-predicate comparison, FDA reviewers must infer equivalence, which often leads to AI requests.
Complizen’s comparison tables help teams map predicate specifications directly to test results, making equivalence easier to assess during review.
Test Method Selection
FDA generally prefers:
Same test methods used by the predicate, when available
Recognized consensus standards (ISO, IEC, ASTM, AAMI)
FDA-recognized standards listed in FDA’s database
Internally validated methods, when no standard exists (with justification)
Using updated or alternative standards is acceptable when scientifically justified and clearly explained.
Sample Size and Data Analysis
FDA does not prescribe fixed sample sizes. Instead, reviewers expect:
Sufficient samples to support reliable conclusions
Predefined acceptance criteria
Appropriate statistical analysis when making comparative claims
Failures should be fully documented, including root cause analysis and any design changes, with retesting as needed.
The Reviewer’s Perspective
FDA reviewers are not checking whether you ran a lot of tests. They are asking:
Do these results convincingly show that any differences from the predicate do not affect safety or effectiveness?
Structuring performance testing around that question, and clearly linking differences to data, is what prevents rework and delays.
Software Validation for Medical Devices: IEC 62304 and FDA Expectations
If your device includes software or firmware, FDA expects software validation evidence demonstrating that the software performs as intended and does not introduce unacceptable risk. While FDA does not mandate a specific standard, IEC 62304 is a commonly used, FDA-recognized framework for organizing software lifecycle activities.
Software Safety Classification (IEC 62304)
IEC 62304 categorizes software based on the severity of harm that could result from a software failure:
Class A: No injury or damage to health possible
Class B: Non-serious injury possible
Class C: Death or serious injury possible
Classification is determined by:
Software-related hazard analysis
Worst-case failure modes
Severity of potential harm
Integration with overall device risk management
The classification must be justified and documented as part of the device risk analysis.
Software Lifecycle Evidence FDA Commonly Expects
The scope of software documentation scales with risk and software safety class. FDA generally looks for evidence covering:
Software requirements and architecture
Risk management applied to software hazards
Verification and validation activities
Traceability showing requirements are tested
Under IEC 62304, higher-risk software requires deeper lifecycle control, including more extensive testing, formal risk management, and change control processes.
In practice, teams struggle with traceability. Mapping software requirements, hazards, and tests in a single workspace makes it much easier to demonstrate control during FDA review. Complizen helps centralize this evidence so gaps are easier to spot before submission.
Core Software Documentation in a 510(k)
FDA commonly reviews:
Software Description
Architecture and major components
Operating environment and hardware dependencies
Third-party software and SOUP components
Software safety classification rationale
Software Requirements
Functional and performance requirements
User interface and alarm behavior
Safety and fault-handling requirements
Verification and Validation Evidence
Test plans and protocols
Executed test results
Anomaly resolution
Traceability linking requirements to tests
Cybersecurity Expectations (2023 FDA Rule)
For devices with connectivity, updateable software, or network interfaces, FDA now enforces premarket cybersecurity requirements under the 2023 final rule.
FDA typically expects:
Secure development practices documentation
Vulnerability management and patching processes
Evidence of security testing appropriate to risk
Testing may include penetration testing, vulnerability scanning, authentication controls, encryption verification, and secure update mechanisms, depending on device risk.
AI and Machine Learning Software
For devices using AI or ML, FDA focuses on:
Training and validation dataset representativeness
Performance metrics and robustness
Bias assessment across populations
Handling of edge cases
FDA has emphasized the importance of a Predetermined Change Control Plan (PCCP) for systems that may evolve post-market.
The Reviewer’s Core Question
Across all software-enabled devices, FDA is asking:
Have you demonstrated that software-related risks are understood, controlled, and validated at a level appropriate to the potential harm?
Clear classification, traceable documentation, and risk-aligned testing are what prevent software-related AI requests.
Biocompatibility Testing for Medical Devices: ISO 10993 Framework
For devices with direct or indirect patient contact, FDA expects a biological evaluation demonstrating that materials do not introduce unacceptable biological risk.
This evaluation is typically structured using ISO 10993-1, an FDA-recognized consensus standard.
Importantly, FDA expects a risk-based evaluation, not automatic testing.
Step 1: Define Contact Type
ISO 10993-1 categorizes devices by how they contact the body:
Surface contact: Intact skin, mucosal membranes, breached or compromised surfaces
External communicating: Blood path, tissue, bone, dentin, or circulating blood
Implant: Tissue, bone, or blood
Correctly classifying contact type is foundational, as it drives which biological risks must be addressed.
Step 2: Define Contact Duration
Duration further influences testing expectations:
Limited: ≤24 hours
Prolonged: >24 hours to 30 days
Permanent: >30 days
Shorter duration and less invasive contact generally correspond to lower biological risk.
Step 3: Identify Biological Endpoints to Address
ISO 10993-1 provides a matrix of biological endpoints to consider, based on contact type and duration. These may include cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, and hemocompatibility.
Not every endpoint requires new testing. FDA allows endpoints to be addressed through:
Existing test data
Predicate device data
Material characterization
Scientific rationale
The key is that every relevant biological risk is addressed and justified.
Using Predicate Biocompatibility Data
FDA may allow you to reference predicate biocompatibility data only when equivalence is well supported.
Common acceptable scenarios include:
Identical material composition, processing, and sterilization
Equivalent or less risky contact type
Equivalent or shorter contact duration
For example, referencing implant-grade material data for a lower-risk surface-contact application may be acceptable if equivalence is clearly demonstrated.
FDA will closely scrutinize these claims and typically expects:
Material specifications and certificates
Processing and sterilization details
Clear justification for biological equivalence
This is an area where teams frequently stumble. Centralizing material specs, predicate references, and biocompatibility rationales makes it easier to demonstrate equivalence without over-testing. Complizen helps keep this evidence traceable and review-ready.
Chemical Characterization (ISO 10993-18)
FDA increasingly emphasizes chemical characterization as part of biological evaluation, particularly for:
New or novel materials
Prolonged or permanent contact
Materials with limited clinical history
Chemical characterization involves identifying potential extractables and leachables and performing a toxicological risk assessment to determine whether biological testing can be reduced or avoided.
For well-characterized, widely used medical-grade materials, FDA may accept a rationale in place of extensive testing, provided it is well documented.
The Reviewer’s Core Question
FDA reviewers are asking:
Have you demonstrated that the materials, contact type, and duration do not pose unacceptable biological risk, using the least amount of testing necessary?
Over-testing wastes time and money. Under-justifying triggers AI requests. The goal is a complete, risk-based biological evaluation.
Specialized Testing Requirements
Beyond performance, software, and biocompatibility, many device types require additional testing to support safety, labeling claims, and substantial equivalence.
Sterilization Validation
Applies to: Any device labeled “sterile.” FDA expects sterilization information appropriate to the sterilization method and the device’s intended use.
Common sterilization standards by method (as applicable):
Typical validation elements (often described as IQ, OQ, PQ):
Installation Qualification (IQ): evidence the sterilization equipment is installed and configured properly
Operational Qualification (OQ): evidence the process operates within defined parameters, including worst-case conditions
Performance Qualification (PQ): evidence the validated process consistently achieves sterility for your defined load and packaging configuration, often using repeated successful cycles under worst-case conditions
Sterility assurance: Terminal sterilization is typically validated to a sterility assurance level (SAL) of 10⁻⁶, unless an alternative approach is scientifically justified.
Common mistake: treating sterilization as a late-stage checkbox, then discovering material, packaging, or functional degradation after sterilization. That creates redesign loops.
Packaging Validation
Applies to: sterile barrier systems and any device with shelf-life claims. Packaging validation is commonly structured around ISO 11607 (FDA-recognized).
Common test categories include:
Package integrity and seal quality
Seal strength testing (commonly ASTM F88)
Package integrity tests, such as burst, leak, or dye-based methods, depending on packaging type and risk
Distribution and transit simulation
Distribution testing commonly follows ASTM D4169 (FDA-recognized) or an ISTA procedure appropriate to the distribution environment.
Aging and shelf life
Real-time aging supports the labeled shelf life directly
Accelerated aging is often designed using ASTM F1980 guidance, with clearly justified assumptions and acceptance criteria
Important correction: Avoid presenting a single “Q10 conversion” as a universal rule. FDA reviewers will look for the assumptions, rationale, and validation plan, not a shortcut formula.
Light Complizen plug that is real: Complizen’s comparison tables make it easy to map shelf-life claims and packaging requirements directly to test evidence, so your submission reads like a clean chain of logic instead of scattered reports.
Electromagnetic Compatibility
Applies to: many electrically powered medical devices, especially medical electrical equipment within scope of IEC 60601 standards. FDA has guidance describing how EMC is evaluated, often using IEC 60601-1-2 or another appropriate recognized standard.
EMC testing typically evaluates:
Emissions, so your device does not disrupt other equipment
Immunity, so your device maintains essential performance during expected electromagnetic disturbances
Practical tip: early pre-compliance checks on prototypes can reduce late-stage surprises.
Electrical Safety
Applies to: many medical electrical devices, often assessed using the IEC 60601-1 series where applicable. FDA references the 60601/80601 family as part of the recognized standards landscape for medical electrical equipment.
Electrical safety testing commonly includes:
Leakage currents and grounding
Insulation and dielectric strength
Temperature and mechanical safety
Ingress protection where relevant
Applied parts (IEC 60601-1 concept):
Type B, BF, CF classifications depend on how the applied part contacts the patient and the required protection level.
Note: Electrical safety and EMC testing are often coordinated together in the same test program.
Testing Strategy: Sequence and Timing
A well-planned testing sequence reduces redesign loops, minimizes retesting, and shortens the path to clearance. FDA does not prescribe a single testing order, but reviewers expect a logical, risk-based progression aligned with design controls and substantial equivalence.
Early Design and Feasibility (Prototype Stage)
Purpose: Identify fundamental technical or material issues before design lock.
Typical activities include:
Feasibility testing to confirm basic functionality
Material compatibility and fit checks
Preliminary performance characterization
Informal EMC or electrical screening to identify obvious risks
This work is usually performed internally or with non-submission labs and is not intended for FDA review. The goal is rapid learning, not regulatory evidence.
Design Verification (Production-Equivalent Configuration)
Purpose: Demonstrate that the finalized design meets engineering and performance specifications.
Often includes:
Full bench and performance testing across operating ranges
Software verification activities (unit and integration testing)
Reliability and durability testing
Initiation of biocompatibility evaluation once materials are locked
Preliminary packaging and labeling evaluations
Verification testing may be performed using internal resources or external laboratories, depending on test complexity and independence requirements.
Design Validation (Market-Ready Configuration)
Purpose: Demonstrate that the device meets user needs and intended use under expected conditions.
Common validation activities include:
Sterilization validation using production-equivalent devices and packaging
Packaging validation, including aging where shelf life is claimed
Final electrical safety and EMC testing on the validated design
System-level software validation
At this stage, design changes should be minimal. FDA reviewers expect validation evidence to reflect the device configuration that will be marketed.
Parallel vs. Sequential Testing
Testing often performed in parallel to save time:
Performance testing and biocompatibility (using separate samples)
Electrical safety and EMC (often coordinated in a single lab program)
Software verification alongside bench testing
Testing that often must follow a sequence:
Design stabilization before final validation
Sterilization validation before final packaging validation (for terminally sterilized devices)
Aging studies before making shelf-life claims
The exact sequence depends on device design, sterilization method, and packaging configuration. There is no one-size-fits-all order.
Using Predicate Devices to Inform Testing Strategy
A practical risk-reduction approach is to study how your predicate device was tested, using publicly available information.
Review the predicate’s 510(k) summary to identify:
Types of testing performed
Standards referenced
Claimed performance parameters
Aligning your test methods and sequencing with an FDA-cleared predicate does not guarantee acceptance, but it often reduces reviewer uncertainty because the approach has precedent within the same device type.
This is where teams lose time. Mapping your test plan against multiple cleared predicates helps ensure you’re neither under-testing nor over-testing. Complizen aggregates predicate 510(k) summaries and highlights the testing approaches FDA previously accepted, making this comparison far faster and more defensible.
The Reviewer’s Lens
FDA is not evaluating whether you followed a “phase model.” They are asking:
Does the testing logically demonstrate that the final device is safe, effective, and substantially equivalent, without gaps or circular logic?
Clear sequencing, documented rationale, and alignment with predicate precedent make that answer easy.
Common Testing Failures That Trigger FDA Retesting
Many Additional Information (AI) requests stem from avoidable testing mistakes. These issues frequently force partial or full retesting and extend review timelines.
Failure #1: Using the Wrong Test Method
Scenario: You perform testing using one method, while your predicate device used a different method. FDA requests retesting using the predicate’s approach or a justified equivalent.
Why FDA cares: Test methods define how performance is measured. If methods differ, results may not be comparable, even if performance looks acceptable.
Prevention:
Identify test methods used by your predicate device
Use the same method where possible, or clearly justify scientific equivalence
Document the rationale before testing begins
Failure #2: Inadequate Sample Size or Statistics
Scenario: You submit testing based on a small number of samples without statistical justification. FDA questions whether results are representative.
Why FDA cares: FDA evaluates whether your data adequately supports safety and effectiveness claims, not whether a specific sample count was used.
Prevention:
Follow recognized standards where sample sizes are defined
Use statistical rationale tied to variability and risk
Define acceptance criteria and analysis methods before testing
Failure #3: Formal Testing Before Design Is Stable
Scenario: You complete formal testing, then make a design change that affects performance, materials, or interfaces. Testing must be repeated.
Why FDA cares: Validation evidence must reflect the final marketed design.
Prevention:
Use informal or feasibility testing during development
Lock design inputs and outputs before regulatory testing
Reserve certified testing for production-equivalent configurations
Failure #4: Sterilization Effects Discovered Too Late
Scenario: Sterilization is validated, but post-sterilization testing reveals degraded performance, material changes, or functional failures.
Why FDA cares: Sterilization is part of the device lifecycle. Performance must be acceptable after sterilization.
Prevention:
Evaluate device performance following sterilization when materials or function could be affected
Incorporate post-sterilization checks into your validation strategy
Consider worst-case sterilization conditions
Failure #5: Missing a Required Specialized Test
Scenario: Your device is subject to Special Controls or device-specific guidance requiring a particular test, which was not included in the submission.
Why FDA cares: Special Controls are legally binding requirements for that device type.
Prevention:
Verify device classification and Special Controls early
Review FDA guidance documents for your product code
Align your test plan explicitly to those requirements
Failure #6: No Comparative Data to Predicate
Scenario: You submit standalone testing showing your device works, but do not demonstrate equivalence to the predicate device.
Why FDA cares: 510(k) clearance is based on substantial equivalence, not standalone performance.
Prevention:
Perform side-by-side testing against the predicate where feasible
Use identical test methods and conditions
Present results in direct comparison tables
The Reviewer’s Question
FDA is not asking:
“Did you test enough?”
They are asking:
“Does this testing logically and directly support substantial equivalence for the final device configuration?”
Clear planning, documented rationale, and predicate-aligned testing prevent most retesting scenarios.
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Critical Takeaways
Your predicate’s testing informs your strategy, not a guarantee.
Using the same test methods, standards, and acceptance criteria as a cleared predicate reduces FDA uncertainty, but differences must still be justified scientifically.
Testing scope varies widely by device.
Electrically powered, software-driven, sterile, or implantable devices typically require broader testing than simple mechanical products. Plan for contingencies.
Some tests inherently take time.
Sterilization validation, aging studies, and reliability testing often drive timelines. Parallel testing can shorten schedules when design allows.
Wrong test methods trigger AI requests.
FDA frequently asks for retesting when submitted methods differ from predicate methods without clear equivalence justification. Verify methods before formal testing.
Biocompatibility data reuse requires true material equivalence.
Identical composition, processing, sterilization, and contact conditions must be justified. If equivalence cannot be demonstrated, independent testing is expected.
Software validation effort scales with risk, not price tags.
Higher software safety classes require more lifecycle evidence, deeper testing, and stronger traceability. FDA evaluates adequacy, not spend.
Validate production-equivalent devices.
FDA expects verification and validation evidence to reflect the configuration that will be marketed. Design changes after testing often invalidate results.
Comparative testing is central to substantial equivalence.
Standalone performance data is rarely sufficient. Side-by-side comparison to the predicate, using the same methods, makes equivalence clear.
Special Controls are mandatory.
Device-specific requirements in the FDA classification database must be addressed explicitly. Missing them almost always results in an AI request.
Pre-Submission meetings reduce risk.
Early FDA feedback on testing plans helps avoid misaligned test strategies and late-stage surprises.