FDA Guidances: IRB Minutes, REMS Counseling, Emerging Technology Submissions, Drug vs Device Classification, De Novo and MDUFA IV, Organ Preservation Devices – Drug and Device Digest

fda guidances


Minutes of Institutional Review Board (IRB) Meetings

IRBs have been cited in Office for Human Research Protections and  FDA Warning Letters for failing to prepare and maintain adequate minutes

  • Minutes are missing
  • Minutes reflect an inaccurate account of meeting attendance
  • Minutes lack sufficient detail to show vote on actions
  • Minutes are incomplete and only describe voting actions as “passed unanimously.”
  • Minutes do not clearly indicate IRB approvals
  • Minutes fail to include  discussion of controverted issues

Minutes need to include:

  • Attendance
  • Actions taken
  • Vote on Actions-for, against, abstaining
  • Requiring changes or disapproving research
  • Controverted issues and resolution



A Framework for Benefit-Risk Counseling to Patients About Drugs with a REMS

Additional risk management steps are required for certain prescription drugs with serious risks, to ensure that the benefits outweigh the risks

  • Part of Risk Evaluation and Mitigation Strategy – REMS
  • Additional steps include  risk communications, patient‒provider agreements, patient counseling tools
  • Warrant higher level of understanding of risks, greater degree of vigilance, activities to ensure benefits outweigh risks
  • Require individualized and collaborative counseling approach

Proposed 4-E Framework 

  1.  Evaluate (and continuously re-evaluate): Individualized health profile, treatment goals, and counseling needs
  2. Educate: Treatment needs and options, potential risks and benefits, importance of  adhering to REMS
  3. Engage: Patient participation in health care decisions and ensuring safe drug use
  4. Ensure: Patient counseling on key risk information and mitigation



Emerging Technology Program : Submission of chemistry, manufacturing, and controls (CMC) information containing emerging technology to FDA

  • Support and enable pharmaceutical innovation and modernization
  • Support flexible approaches  to advance product design, modernize pharmaceutical manufacturing, improve quality
  • Adopt innovative approaches by leveraging existing FDA resources to facilitate  regulatory assessment of novel technology submissions

Discussion of Scope and Process




Classification of Products as Drugs and Devices & Additional Product Classification Issues

To address Requests for Designation (RFDs)  whether a product should be classified as either a drug or a device

  • RFD guidance on obtaining formal determination of product’s classification
  • FDA’s decision-making process for classification determinations

Statutory Definitions

  • Drug
  • Device

Key provisions of Device definition

  • “Similar or related article”
  • “Primary intended purposes”
  • “Chemical action”
  • “Within or on the body”
  • Illustrative Examples



FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals

MDUFA IV authorizes user fees for De Novo classification requests

  • Additional funds  to improve the device review process
  • Meet certain performance goals
  • Implement improvements for device review process

FDA Actions 

  •  Issue an Order Granting the Request to Classify the Device
  • Issue an Order Declining the Request
  • Request Additional Information (AI)
  • Issue a Notice of Withdrawal

De Novo Performance Goals for MDUFA IV

  • Submission
  • FDA Review
  • MDUFA IV Goals
  • Missed MDUFA Decision Communication

Requester Actions 

  • Response to an AI Request
  • Request for Withdrawal of the De Novo Request





Shortage of organs available for transplants has propelled innovation in organ preservation technologies

  • Best practices for utilizing animal studies for the evaluation of organ preservation devices
  • To support IDE, PMA, HDE, 510(k), De Novo applications/requests

Overview and General Study Design Considerations

  • Procedure Duration
  • Contamination
  • Transportability

Reperfusion Models

  • Ex Vivo Models
  • In Vivo Models

Sample Panel of Biomarkers in Liver

  • Liver Injury Biomarkers
  • Liver Function Biomarkers


Image credit: FDA


Scroll to Top