Regulatory and Compliance Considerations for U.S. Human Factors Validations
Chad Gibson, Quality Manager, Battelle, Columbus OH
ABSTRACT
METHODS
APPROACH
Human Factors Validation is a key component of a medical
device development process. When a device is classified as
a medical device (or a drug/device/biologic combination
product), regulations, guidance, and recognized consensus
standards will apply to the Human Factors Validation project.
This poster presents an overview of the best practices
developed by Battelle Medical Products to ensure Human
Factors Validation is adequately performed.
Is My Product a Medical Device (or a Combination Product)?
Medical Device Definition (found in FD&C Act,
Sec 201(h)): A device is: “an instrument, apparatus,
implement, machine, contrivance, implant, in vitro reagent, or
other similar or related article, including a component part, or
accessory which is: […] intended for use in the diagnosis of
disease or other conditions, or in the cure, mitigation,
treatment, or prevention of disease[…]”
1. Is my product a medical device?
2. What regulations, standards, and guidance apply to
Human Factors Validation?
3. How do I apply these principles to my Human Factors
Validation project?
CONCLUSIONS
• Combination products containing medical devices must adhere to
design control regulations for medical devices
FDA Combination Product Examples
•
•
•
•
•
Prefilled syringes
Insulin injector pens
Metered dose inhalers
Transdermal patches
Drug packaged with delivery device
What Regulations, Standards, and Guidance Apply to Human Factors Validation?
Regulations
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•
•
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Quality System Regulation – 21 CFR 820
Design Validation – 21 CFR 820.30
Electronic Records and Electronic Signatures – 21 CFR 11
CGMP Requirements for Combination Products - 78 FR
4307
• Human Subjects Research – 45 CFR part 46 (not covered)
Recognized Consensus Standards
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•
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ANSI/AAMI/IEC 62366:2007
AAMI/ANSI HE75:2009
ANSI/AAMI/ISO 14971:2007
IEC 60601-1:2005 (for electrical medical devices)
Guidance
• Applying Human Factors and Usability Engineering to
Optimize Medical Device Design (2011, Draft)
• Design Control Guidance For Medical Device
Manufacturers (1997)
• Human Factors Implications of the New GMP Rule Overall Requirements of the New Quality System
Regulation (1997)
How Do I Apply These Principles to My Human Factors Validation Project?
Document Controls
• Quality System
conforming with QSR
and ISO 13485:2003
• Pre-approved written validation protocols
• Usability engineering plans, safety risk
management documentation (plan, risk
assessments, reports)
• Verified copies; document and revision numbers
Training
Documented
investigator training on validation protocol and
human subjects research requirements
Calibration and
Validation of Tools
• Measurements performed
using calibrated equipment, e.g.:
– Seconds to complete a task
– Pounds of force used to remove a cap
• Any electronic record or electronic signature systems used
to record or calculate validation data should conform with
21 CFR Part 11, e.g.:
Safety Risk
Management (SRM)
• Conformance with
ISO 14971:2007
• SRM team includes clinical expert(s)
• SRM includes assessments of use error
and foreseeable misuse scenarios
• If devices are not from the final production line, be ready to
explain why those differences have no impact on the
validation effort
• The validation environment should simulate actual use
conditions as much as practicable – be prepared to explain
why differences have no impact in the validation outcome
• Human Factors and Design Validation must be conducted under a
quality system and include elements of document and records
control, calibration, and tool validation
What Have We Seen?
FDA is rejecting medical device and combination product
submissions due to lack of Human Factors data.
• Combination products not submitted as such; lack of Device
History File (DHF), including Human Factors (HF) data
• Blockbuster drug / biologic launches delayed due to lack of HF
data on device use
• HF Validation not performed adequately (participant numbers,
actual use environments)
Other Key Take Aways from the Field
• Design control regulations apply to usability engineering programs.
This increases the level of rigor necessary during formative and
validation efforts. A “market research” based approach often does not
have the required quality control elements.
• An approved pen injector with a new drug/biologic might require
additional usability efforts. Variations in user profiles, viscosities,
disease states, etc. may pose new or untested usability efforts.
• “We are not creating a combo product, we are just including a syringe
in the box – no user testing needed”
– If the standalone device is classified as a medical device, it will most
likely be classified as a combination product.
– Electronic Case Report Forms (CRFs)
– Storage of electronic files used for submission or analysis, e.g.,
videos used for offline task analysis
– Statistical calculation tools, e.g., Excel, MINITAB, SAS, Stata
Production Equivalence and Actual Use
Conditions (21 CFR 820)
• In our experience, the most predictable regulatory pathway is the
early incorporation of Usability Engineering in accordance with IEC
62366 and ISO 14971
Records
Management
• Good documentation
practices
• Patient privacy / HIPAA
• Records retention
• Data transcription (e.g., to electronic)
• Conforming with guidance documents is “optional.” But at your own
risk! This may end up making your clearance/approval timeline very
unpredictable.
• Risk management activities should not be performed solely by internal
product development teams. Risk management in accordance with
ISO 14971 requires that clinical representatives play an active role in
defining risk.
• Usability engineering cannot occur after a drug delivery device has
been fully designed. A usability engineering program in accordance
with IEC 62366 is intended to span the product’s development
lifecycle, with the intent of designing out usability-related risk.
This poster represents the interpretation of FDA regulation and guidance by Battelle Medical
Products and should not be considered a regulatory opinion.
www.battelle.org