FDA BRIEF: Week of December 26th, 2016 and January 2nd, 2017
SCOPE
- FDA recommendations for managing postmarket cybersecurity vulnerabilities
- Emphasis on monitor, identify, and address cybersecurity vulnerabilities
- Establishes risk-based framework for assessing when changes to medical devices for cybersecurity vulnerabilities require FDA reporting
GENERAL PRINCIPLES
- Premarket considerations
- Postmarket considerations
- Maintaining safety and essential performance
MEDICAL DEVICE CYBERSECURITY RISK MANAGEMENT
- Assessing explolitability of cybersecurity vulnerability
- Assessing severity of patient harm
- Evaluation of patient harm
REMEDIATING AND REPORTING CYBERSECURITY VULNERABILITIES
- Controlled risk of patient harm
- Uncontrolled risk to safety and essential performance
RECOMMENDED CONTENT TO INCLUDE IN PMA PERIODIC REPORTS
CRITERIA FOR DEFINING ACTIVE PARTICIPATION BY A MANUFACTURER IN AN ISAO
ELEMENTS OF AN EFFECTIVE POSTMARKET CYBERSECURITY PROGRAM
- Identify
- Maintaining safety and essential performance
- Protect/Detect
- Vulnerability characterization and assessment
- Analysis of threat sources
- Incorporation of threat detection capabilities
- Im[act assessment of all devices
- Protect/Respond/Recover
- Risk mitigation of safety and essential performance
SCOPE:
Benefit and risk factors, including reliable patient input, for prioritizing resources for product availability, compliance and enforcement efforts and for informed and science-based decisions
DESCRIPTION OF FACTORS
- Assessment of Benefits
- Assessment of Risks
- Additional Factors to Consider
PATIENT FOCUS IN BENEFIT-RISK ASSESSMENT
EXAMPLES
- Product Availability Decisions
- Compliance and Enforcement Decisions.
OTHER
- Intersection with ISO 14971
- Worksheets for Benefit Assessments
- Worksheets for Risk Assessments
- Worksheet for assessing potential decisions based on the Benefit-Risk Assessment Outcome
SCOPE: Risk- and Regulatory control-based Classification of accessories and use of the De Novo classification process.
ACCESSORY: A finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices. Includes Software
TRADITIONAL CLASSIFICATION APPROACH: Same as parent device OR Unique, separate classification
NEW REGULATIONS PER 21ST CENTURY CURES ACT: classify an accessory . . . based on the intended use of the accessory, notwithstanding the classification of any other device with which such accessory is intended to be used
DE NOVO PATHWAY ENCOURAGED: For new types of accessories
SCOPE: Current thinking on relevant bench testing methods for bone anchor devices including nitinol and absorbable polymeric bone anchors
- Classified under:21 CFR 888.3030, CFR 888.3040
- Product Codes: MAI, MBI
510(K) SUBMISSION RECOMMENDATIONS
- Device Description: General Suture, Anchors, Nitinol Suture Anchors, Polymeric Absorbable Suture Anchors
- Predicate Comparison
- Biocompatibility
- Sterility
- Reprocessing
- Shelf-Life and Packaging
- Magnetic Resonance Compatibility
- Non-Clinical Performance testing: Suture Characterization, Insertion Testing, Pullout Testing, Component Interconnection Testing, Fatigue Testing, Corrosion (Nitinol), Degradation Testing
- Clinical Performance Testing
- Labeling
- Modifications
SCOPE: Unique nature of botanical drugs leading to different regulatory policiesfor nonbotanical drugs
- Pre-IND, end-of-phase 1, end-of-phase 2 and 2A, pre-phase 3, and pre-NDA consultations strongly encouraged
IND FOR PHASE 1 AND PHASE 2 CLINICAL STUDIES
- Description of Product and Documentation of Prior Human Experience
- Chemistry, Manufacturing, and Controls
- Nonclinical Pharmacology/Toxicology
- Clinical Pharmacology
- Clinical Considerations
IND FOR PHASE 3 CLINICAL STUDIES
- General Regulatory Considerations in Late-Phase Development
- Description of Product and Documentation of Prior Human Experience
- Chemistry, Manufacturing, and Controls
- Nonclinical Safety Assessment
- Clinical Pharmacology
- Clinical Considerations
- Applicability of Combination Drug Regulations.
NDA FOR BOTANICAL DRUG PRODUCTS
- Description of Product and Documentation of Prior Human Experience
- Quality Control
- Nonclinical Safety Assessment
- Clinical Pharmacology
- Clinical Evidence of Efficacy and Safety
- Evidence To Ensure Therapeutic Consistency
- Postmarketing Considerations