FDA BRIEF: Week of December 26th, 2016 and January 2nd, 2017

fda guidances


cyber.JPG

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

READ


Capture.JPG

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

READ


accessory.JPG

 

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

READ


bone.JPG

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

READ


botanical.JPG

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

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