FDA Guidances: Multiple Function Device Products, Pregnant Women in Clinical Trials, Atopic Dermatitis Pediatric Studies, PRO Tool for COPD, BIMO Inspection Information – Drug and Device Digest


Multiple Function Device Products: Policy and Considerations

Products with at least one device function are referred to as “multiple function device products.”

  •  Function : Distinct purpose of the product, which could be intended use or subset
  • Examples: One function: analysis or three functions: storage, transfer, analysis
  • Product may contain multiple functions
    • – may / may not meet definition of ‘device’
    • -meet definition of device, but not subject to premarket review
    • -meet definition of device, but no enforcement of  compliance with applicable regulatory controls  (enforcement discretion policy)
  • Applies to device constituent of combination product


  • No regulation if does not meet ‘device’ definition
  • However, when assessing safety and effectiveness, FDA may assess the
    impact of the other function.
    235 compliance with applicable requirements. In accordance with existing policies, FDA intends not
    236 to review a device function subject to an enforcement discretion policy merely because it is part


  • Separation in design and implementation of device function
  • Impact of other function(s)
  • Assessing impact of other functions on device function-under-review
    • Impact on safety or effectiveness
    • Result in increased risk or adverse effect on performance
    • Impacts to safety and effectiveness

Content of premarket submission for Device Function-Under-Review

  • Indications for Use, Description of Functions, Architecture and Design, Risk Analysis, Requirements and Specifications, Submission Summary



Pregnant Women: Scientific and Ethical considerations for Inclusion in Clinical Trials

Inclusion of pregnant women in drug development clinical trials 

  • For safe and effective treatment during pregnancy
  • Establish dose/dosing regimen, safety, and efficacy of treatments during pregnancy
  • Enrollment of pregnant women may offer direct benefit to woman and/or fetus
  • For accessible treatment options for pregnant population

Ethical Considerations

  • FDA Regulations That Govern Research in Pregnant Women
  • Research-Related Risks
  • General Guidelines for Including Pregnant Women in Clinical Trials

Other Considerations

  • Disease Type and Availability of Therapeutic Options in Pregnant Population
  • Timing of Enrollment
  • Pharmacokinetic Data
  • Safety Data Collection and Monitoring
  • Stopping a Clinical Trial That Enrolls Pregnant Women



Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs

Relevant age groups to study and how early in a pediatric Atopic Dermatitis (AD) drug development

  • AD is chronic pruritic inflammatory skin disease primarily affecting pediatric patients
  • Based on input received Dermatologic and Ophthalmic Drug Advisory Committee


  • Base on labeling information on relevant pediatric populations and safe and effective use
  • Initiate early in development, typically after obtaining initial evidence of efficacy and safety from early phase adult studies
  • Discuss specifics as early as is feasible with FDA to submit pediatric study plans
  • Consider juvenile animal toxicity study with appropriate endpoints
  • Not generally necessary to have extensive adult safety database
  • Study all relevant age groups, including children < 2 yo



Chronic Obstructive Pulmonary Disease: Use of the St. George’s Respiratory Questionnaire (SGRQ) as a PRO Assessment Tool

Use of St. George’s Respiratory Questionnaire (SGRQ), a patient reported outcome measure (PRO) assessment tool for interventional clinical trials in COPD
  • COPD is chronic progressive disease caused by chronic inflammation and destruction of airways and lung parenchyma
  • Usually associated with tobacco smoking or prolonged exposure to other noxious particles and gases
  • SGRQ measures health status in patients with obstructive airway diseases
PRO assessment of efficacy
  • Use for stratification or enrichment purposes in protocol development phase.
  • Use as coprimary endpoint or as secondary endpoint
  • Clinically important and sponsor should report clinical trial data irrespective of  direction of results
Considerations for SGRQ
  • Use current version from St. George’s University of London Health Status Research website at http://www.healthstatus.sgul.ac.uk/
  • Administration
  • Scoring
  • Method of Analysis
  • Use of the SGRQ
Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions
To plan BIMO inspections for timely identification of inspection sites and provide information to FDA -ORA investigators 
  •  Clinical Study-Level Information
  • Comprehensive table listing all participating clinical sites
  • Table listing all entities with contracted clinical study-related activities
  • Protocol, protocol amendments, annotated Case Report Form(s)
  • Subject-level data line listings by clinical site
  • Summary-level clinical site dataset



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