Interim Results of Duodenoscope Reprocessing Studies Conducted in Real-World Settings: FDA Safety Communication

FDA ordered all U.S. duodenoscope manufacturers (Olympus, Fujifilm, Pentax) to conduct 2 postmarket surveillance studies on whether health care facilities were able to properly clean and disinfect devices

  • Study to sample and culture reprocessed duodenoscopes
  • Study to nassess how effectively the trained hospital staff follow the manufacturer reprocessing instructions (human factors)
  • At least 10% of the samples have been collected assuming <0.4% contamination rate

Interim results indicate higher-than-expected contamination rates after reprocessing

  • Up to 3% samples testing positive for enough low concern organisms
  • Up to 3% of samples testing positive for high concern organisms- E. coli,  Pseudomonas aeruginosa
  • Root cause analyses are underway;  final results in 2019

Safety communication to hospitals and health care providers

  • Following the manufacturer’s reprocessing and maintenance instructions not sufficient to avoid all infections
  • FDA been working with developers on new product designs, including disposable components



Biomarker Qualification: Evidentiary Framework

Evidentiary framework to support biomarker qualification with recommended components

  • Type and level of evidence
  • Broadly applicable regardless of the type of biomarker or context of use (COU)
  • Qualified biomarker can be used across multiple drug development programs

Framework consists of 

  • Drug development need
  • Defining the COU
  • Potential benefits if the biomarker is qualified for use
  • Potential risks of biomarker in drug development program

Biomarker validation




Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures


  • Medical device classification procedures for certain devices and requiring premarket approval applications for preamendments to Class III devices by using administrative orders, rather than rulemaking
  • Do not affect the classifications of previously cleared or approved devices

Principle benefits

  • Reduction in regulatory and economic burden and decreased timelines by eliminating paperwork filing requirements
  • Enhanced consistency and uniformity across reclassification proceedings
  • Cost and time savings will accrue to both medical device manufacturers and to Agency.



Data Integrity and Compliance With Drug CGMP

Clarify role of data integrity in current good manufacturing practice (CGMP) for drugs

  • All data expected to be reliable and accurate
  • Flexible and risk-based strategies to prevent and detect data integrity issues
  • Consider design, operation, monitoring based on risk to patient, process, product
  • Management’s involvement essential in preventing and correcting conditions that lead to data integrity problems.
  • Create a quality culture with data integrity as core value

Q & As on broad range of topics provided



Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment Guidance for Industry

Guidance for clinical development of drugs for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis

  • Necessary components of drug development program


  • General Considerations
  • Phase 2 Development Considerations: Early and Late trials
  • Phase 3 Development Considerations: Inclusion / Exclusion criteria,  trial design and efficacy endpoints, safety considerations, pediatric considerations

NASH guidance


Report on Non-Device Software Functions 

Certain software functions excluded from definition of device under section 201(h) FD&C Act (21 U.S.C. 321(h))

  • Administrative support of a health care facility
  • Maintaining or encouraging a healthy lifestyle and unrelated to the diagnosis, cure, mitigation, prevention, or treatment of disease or condition
  • Serving as electronic patient records; not intended to interpret or analyze
  • Transferring, storing, converting formats, displaying data
  • Certain types of clinical decision support to a health care provider unless interpreting or analyzing

Report based on information from: DHHS offices, representatives of patients, consumers, health care providers, startup companies, health plans or other third-party payers, venture capital investors, information technology

Analysis based on: Impact to patient safety, Benefits and risks to health, Best practices to promote safety, education, and competency

Findings: More benefits than risks to patient safety and health related to these software functions

Details best practices: Implementation, training techniques, and use, which could promote safety, education, and competency related to these software functions


Image credit: FDA