fda guidances


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Deciding When to Submit a 510(k) for a Change to an Existing Device

510(k)s for changes to a legally marketed device should consider Quality System (QS) regulation

  • For some types of changes submission of new 510(k) not required
  • Reliance on existing QS requirements is the least burdensome approach

Guiding Principles

  • Changes made with intent to significantly affect safety or effectiveness
  • Initial risk-based assessment
  • Unintended consequences of changes
  • Use of risk management
  • Role of testing in evaluating effect on safety and effectiveness
  • Evaluating simultaneous changes
  • Appropriate comparative device and cumulative effect of changes
  • Documentation requirement
  • 510(k) submissions for modified devices
  • Substantial equivalence determinations

Overview

  • Labeling Changes
  • Technology, Engineering, and Performance Changes
  • Materials Changes
  • Technology, Engineering, Performance, and Materials Changes for In Vitro Diagnostic Devices
  • Considerations for Risk-Based Assessments of Modified Devices

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Deciding When to Submit a 510(k) for a Software Change to an Existing Device

When software (including firmware) change to medical device may require 510(k)

  • Enhance predictability, consistency, transparency of the “when to submit”
  • Provide a least burdensome approach, regulatory framework, policies, practices

Guiding Principles

  • Changes made with intent to significantly affect safety or effectiveness
  • Initial risk-based assessment
  • Unintended consequences of changes
  • Use of risk management
  • Role of testing in evaluating effect on safety and effectiveness
  • Evaluating simultaneous changes
  • Appropriate comparative device and cumulative effect of changes
  • Documentation requirement
  • 510(k) submissions for modified devices
  • Substantial equivalence determinations

Additional guidance

  • Use flowchart in concert with the Guiding Principles
  • With multiple changes, use all applicable parts of flowchart and companion text, including the Guiding Principles

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Clinical Drug Interaction Studies — Study Design, Data Analysis, and Clinical Implications

Conduct of clinical studies to evaluate Drug-Drug Interaction (DDI) potential

  • Timing and design of clinical studies
  • Interpretation of study results
  • Options for managing DDIs in patients

Goals of studies to determine

  • Whether investigational drug alters pharmacokinetics of other drugs
  • Whether other drugs alter pharmacokinetics of investigational drug
  • Magnitude of changes in pharmacokinetic parameters
  • Clinical significance of observed or expected DDIs
  • Appropriate management strategies for clinically significant DDIs

Considerations

  • Timing, Types, Design and conduct of DDI sudies
  • Stand-Alone and Nested Prospective DDI Studies
  • CYP-Mediated Interactions
  • Transporter-Mediated Interactions
  • Reporting and Interpretations
  • Labeling recommendations

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Capture.JPGBreakthrough Devices Program

Breakthrough Devices Program for certain medical devices for life-threatening or irreversibly debilitating diseases or conditions

 

  • Expedites development, assessment, FDA review, while preserving statutory standards
  • Supersedes the Expedited Access Pathway (EAP)

Considerations

  • Program Principles
  • Program Features
  • Designation Request
  • Designation Review Process
  • Designation Withdrawal

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Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request

Patients play an active role in their own healthcare

  • May request personal information that has been recorded, stored, processed, retrieved, and/or derived from marketed medical device
  •  Sharing “patient-specific information”  upon request may assist in being more engaged with healthcare providers in making sound medical decisions

Categories of patient-specific information for sharing

  • Data healthcare provider inputs in device to record status and ongoing treatment
  • Information stored by device to record usage, alarms, or outputs (e.g., pulse oximetry data, heart electrical activity)
  • Case logs entered into device by healthcare provider

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De Novo Classification Process (Evaluation of Automatic Class III Designation)

To provide guidance on the process for the submission and review of a De Novo classification request

  • for cases where there is no predicate device or has received an NSE determination on a 510(k) submission
  • specific device and device type is classified in class I or class II
  • publish a notice in the Federal Register announcing classification and controls necessary to provide reasonable assurance of safety and effectiveness

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Acceptance Review for De Novo Classification Requests

To explain FDA procedures and criteria for acceptability for substantive review of De Novo classification request  

  • Making “Accept” or “Refuse to Accept” (RTA) decisions

De Novo Acceptance Review Policies and Procedures

  • Acceptance Review Policies and Procedures
  • FDA Review Clock
  • Notification of Acceptance Review Result
  • Refuse to Accept Principles

Checklist Acceptance Review

  • Organizational Elements
  • Elements of a Complete De Novo Request (RTA Items)
  • Applying the Checklist of RTA Items
  • Elements Marked as “Not Applicable” (N/A)
  • Adequacy of Information
  • Elements Marked “No”

Recommended Content Checklist

  • Purpose
  • Prior Submission(s) Relevant to the De Novo Request Under Review

Checklists

  • Acceptance Checklist for De Novo Classification Requests
  • Recommended Content Checklist for De Novo Classification Requests

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