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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

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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

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

Scope

  • 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.

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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

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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

Overview:

  • 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


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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

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Image credit: FDA

 

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