FDA Brief, Week of Jan 11, 2016 – Drug and Device Digest

CDRH Priorities


  • Establish a National Evaluation System for medical devices : To successfully harness from the diverse set of real-world evidence in an efficient manner
    • Increase access to real-world evidence to support regulatory decision-making
    • Increase use of real-world evidence to support regulatory decision-making
  • Partner with Patients; interact with patients as partners and work together to advance the development and evaluation of innovative devices, and monitor the performance of marketed devices
    • Promote a culture of meaningful patient engagement by facilitating CDRH interaction with patients
    • Increase use and transparency of patient input as evidence in decision-making
  • Promote a culture of quality and organizational excellence; manufacturer’s ability to design and make high-quality, safe and effective devices and CDRH’s ability to provide the necessary oversight to assure devices on the market are high-quality, safe and effective 
    • Strengthen culture of quality within CDRH
    • Strengthen product and manufacturing quality within medical device ecosystem



FDA Voice

Progress and Collaboration on Clinical Trials

Barbara D. Buch, M.D, . Chair of the 907 Steering committee and the Associate Director for Medicine in FDA’s Center for Biologics Evaluation and Research

Based on Congress’s directive in Section 907 of FDASIA, FDA looking more closely at sex, age, and race/ethnicity data collected in clinical trials.

Three priorities:

  • improving the quality and comprehensiveness of demographic subgroup data collection, reporting and analysis
  • identifying and eliminating barriers for increased participation in clinical trials
  • improving the transparency of subgroup data.


  • Public meeting on this topic on February 29.
  • Guidances : Integrated Summary of Effectiveness: Guidance for Industry & Evaluation of Sex-Specific Data in Medical Device Clinical Studies
  • Supportive Programs across FDA’s Divisions and Offices : Office of Minority Health (OMH), CDER, CDRH
  • Updated Medwatch Forms to standardize collection of demographic information


  • OWH and NIH collaborative workshop on importance of diversity
  • Availability of demographic data through ‘Drug Trials Snapshots’
  • FDA and Johns Hopkins University co-sponsored clinical trials workshop on Safety and Efficacy for a Diverse Population


  • Language Access Plan Working Group to address needs of under-represented subpopulations
  • CBER transparency pilot program for open access to demographic information from BLAs
  • CDRH modified templates for certain medical devices to ensure inclusion of demographic information


CDER conversations

Compendium of CLINICAL OUTCOME ASSESSMENTS (COAs) to promote the use of patient-focused outcome measurement in drug development

Elektra Papadopoulos, M.D., MPH, Acting Associate Director, Clinical Outcome Assessments Staff, Office of New Drugs, CDER, FDA


What is patient-focused outcome measurement about?

Understanding of the impact of a disease on the people who have it, and what they value most in terms of alleviating symptoms

How does patient input influence the choice of outcome measures in drug development?

Patient input into the selection of outcomes that are meaningful to them can profoundly influence drug development by ensuring the patient voice is captured.

What is a clinical outcome assessment and how are COAs captured in drug development?

COAs are captured using four types of COA measures: patient-reported, clinician-reported, observer-reported, and performance outcome measures.

What are patient-reported outcomes?

Patient-reported outcomes (PROs) are outcomes that are based on reports coming directly from the patient about how he or she feels or functions as a result of treatment. PROs may not always be feasible or appropriate depending on the particular context, and other types of COAs may be utilized.

What is the COA Compendium? And what is its purpose?

Table describing use of COAs in drug development related symptoms) and support labeling claims

Designed to be used as a starting point when considering the use of COAs in clinical trials

Why is this COA Compendium important and what does it mean for patients?

Tool to foster patient-focused drug development mission and  to see knowledge gaps

Is FDA encouraging drug companies to consider using PROs in trials that support approval of a drug?


Will this compendium be an all-conclusive list of COAs?

No – this is a pilot. Hope to get public comment to expand scope.

Where can people find the COA Compendium?

Federal Register notice seeking review and comment on the content and format of the compendium

What type of information are you hoping to obtain?

Seeking public feedback on the utility, approach for development, suggestions for future approaches to expand scope of COA Compendium




Clinical Outcome Assessment (COA) Compendium


  • Describes clinical outcome assessments to support labeling claims
  • Identifies clinical outcome assessments qualified for potential use
  • Recognizes ongoing qualification projects


  • Not a comprehensive list
  • Sponsors strongly encouraged to seek advice from the relevant Office of New Drug (OND) review division early in drug development
  • Inclusion in COA Compendium does not equate to an FDA endorsement


  • CDER’s DDT COA Qualification Program
  • Drug Labeling Approved From 2003 to 2014 (New Molecular Entity (NME) labeling)


  • Importance of collaborative development of COAs in response to unmet measurement needs
  • Provides regulatory conclusion on specific COA, specific interpretation and application in regulatory review
  • Inclusion of labeled COA serve as additional resource


  • Table alphabetically listing conditions or diseases
  • Six Columns :
    • Disease Condition
    • Indication and/or Claim(s) Description
    • Outcome of Interest
    • COA (COA Type)
    • COA Context of Use
    • COA Qualification Information


  • Not a comprehensive list
  • Not a replacement for FDA interactions or supersede existing guidances

FDA seeking public feedback 
FDA will host Webinar


fda guidances


CDRH Draft Guidance on Cybersecurity

  • Recommendations for monitoring, identifying and addressing cybersecurity vulnerabilities and exploits as part of medical device management
  • General principles for Pre-Market and Post-Market considerations, essential clinical performance
  • Risk management based on exploitability of the cybersecurity vulnerability, and health impact severity if the vulnerability were to be exploited
  • Remediating and Reporting vulnerabilities including controlled and uncontrolled risks to essential clinical management
  • Content for PMA Periodic Reports including description of vulnerability, sponsor conclusion and description of changes made
  • Elements of an Effective Postmarket Cybersecurity Program : Identify, Protect/Detect, Protect/Respond/Recover
  • To be discussed at the Jan 2021 FDA Workshop on Cybersecurity





POCA – Phonetic and Orthographic Computer Analysis

  • Part of CDER, Office of Surveillance and Epidemiology (OSE), Division of Medication Errors Prevention and Analysis (DMEPA)’s mission to prevent medication errors due to proprietary name confusion
  • POCA is a web application to determine written and phonetic similarities between proposed drug names using advanced algorithms
  • Compares a drug name against multiple drug names found in several different “data sources” contained in the software
  • FDA is providing zip files to download and install to help Sponsor evaluate potemtial proprietary names vs FDA database. – ‘Drugs @ FDA’ and ‘RxNorm’



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