FDA Guidances: Drug Development Tools, Clinical Consultative Review, Certifications, Reusable Medical Devices, QT/QTc Prolongation – Drug and Device Digest

fda guidances

Updated Process for Qualification of Drug Development Tools (DDT) Under New FD&C Act Section 507

DDT Qualification to follow updated, multi-stage process under 21stCentury Cures Act 

  • 3 submission milestones: Letter of Intent (LOI), Qualification Plan (QP), Full Qualification Package (FQP)2
  • Transparency provisions and public posting of information by FDA
  • To transition from legacy qualification program process to new section 507 DDT Qualification Process


Good Review Practice: Clinical Consultative Review of Drugs Regulated with OND

Describes  clinical consultative review process in the CDER Office of New Drugs (OND)  for INDs, NDAs, BLAs, and supplemental NDAs and BLAs

  • To gather expertise of second review division because of familiarity with drug for other uses, expertise in another aspect of disease or organ system


Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions

Form 3674: All Drug, Biologic, Device Submissions require certification that all applicable requirements have been met (implemented in 2007)

  • Form FDA 3674 can be obtained at LINK
  • Requires submitter to confirm compliance with all applicable requirements of Title VIII, including applicable implementing regulations, e.g., the requirement to register applicable clinical trials
  • Guidance to provide clarifications and additional details


Validated Instructions for Use and Validation Data Requirements for Resuable Medical Devices


List of reusable medical devices for which the FDA will require for premarket submissions:

  • validated instructions for use
  • validation data regarding cleaning, disinfection, and sterilization
  • in accordance with the requirements of 21st Century Cures Act
  • facilitates 510(k) reviews


E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs — Questions and Answers (R3)

ICH E14 guidance Clinical Evaluation of QT/QTc Interval Prolongation finalized in 2005

  • This guidance for clarifying key issues
  • Sex Differences, Incorporating New Technologies, Concentration-Response Relationships, Combination Products, Large Targeted Proteins and Monoclonal Antibodies, and Special Cases, Use of Concentration Response Modeling


  • Electrocardiograms Methodology
  • Gender
  • Positive Control
  • Study Design
  • Concentration Response Modeling
  • Special Cases
  • Electrocardiograms monitoring in late stage clinical trial



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