Description
FDA is issuing this draft guidance to communicate when and what methods could be used to collect and submit patient preference information (PPI) across the total product life cycle. This will include helping explain when PPI may be helpful, and in what context. Without this re-issuance, sponsors and other patient preference study developers will not be aware of updated methodologies and considerations, which could result in costly studies that may not be appropriate to inform benefit-risk decision making. This update, when finalized, will provide more clarity in when and in what contexts different methods are best applied.
Scope & Applicability
Product Classes
8Medical devices regulated by the Center for Devices and Radiological Health
includes smaller prosthesis sizes and is inserted via a surgical procedure
Telephone follow-up after surgery
FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices
Medical devices regulated by the Center for Biologics Evaluation and Research
Devices used for obesity treatment where PPI informed benefit-risk tolerance.
Device cleared for solo home use based on PPI study results.
Novel device where PPI established the performance goal for effectiveness.
Stakeholders
6Assist sponsors in the nonclinical evaluation
Convened to provide advice on withdrawal issues
Institutional Review Board providing study approvals
Entity responsible for submitting applications under section 524B
Individuals such as parents whose preferences may be considered; involved in early stage qualitative discussions
Users whose characteristics impact user needs and communication format.; Intended users of the AI-enabled device; Intended User: Healthcare professionals
Regulatory Context
Attributes
9Assessment for both mother and child
quantitative PPI can be used to help define the minimum clinically meaningful benefit
Balance between potential gains and harms
context defined in patient preference studies; parents surveyed prefer the benefit-risk tradeoff of this new device; patient willingness to accept risks in exchange for benefits
Applicability of HCEI from one health care setting to another.
Variations in patient preferences even within the same disease state
When patient decisions regarding options vary based on personal values
A patient's willingness to accept identified risks
expressed as kilograms of weight divided by height in meters squared (kg/m²); percentage change in body weight equals percentage change in BMI
Identified Hazards
Hazards
1potential biases such as framing, anchoring, or ordering effect
Related CFR Sections (7)
- 21CFR814.116§ 814.116 Procedures for review of an HDE.
(a) Substantive review. FDA will begin substantive review of an HDE after the HDE is accepted for filing under § 814.112 . FDA may refer an original HDE application to a panel on its own initiative, and shall do so upon the request of an applicant, unless FDA determines that the application substantRead full regulation →
- 21CFR814.44§ 814.44 Procedures for review of a PMA.
(a) FDA will begin substantive review of a PMA after the PMA is accepted for filing under § 814.42 . FDA may refer the PMA to a panel on its own initiative, and will do so upon request of an applicant, unless FDA determines that the application substantially duplicates information previously revieweRead full regulation →
- 21CFR814.15§ 814.15 Research conducted outside the United States.
(a) Data to support PMA. If data from clinical investigations conducted outside the United States are submitted to support a PMA, the applicant shall comply with the provisions in § 812.28 of this chapter , as applicable.Read full regulation →
- 21CFR812.28§ 812.28 Acceptance of data from clinical investigations conducted outside the United States.
(a) Acceptance of data from clinical investigations conducted outside the United States to support an IDE or a device marketing application or submission (an application under section 515 or 520(m) of the Federal Food, Drug, and Cosmetic Act, a premarket notification submission under section 510(k) Read full regulation →
- 21CFR860.7§ 860.7 Determination of safety and effectiveness.
(a) The classification panels, in reviewing evidence concerning the safety and effectiveness of a device and in preparing advice to the Commissioner, and the Commissioner, in making determinations concerning the safety and effectiveness of a device, will apply the rules in this section.Read full regulation →
- 21CFR812.20§ 812.20 Application.
(a) Submission.Read full regulation →
- 21CFR812.25§ 812.25 Investigational plan.
The investigational plan shall include, in the following order:Read full regulation →
Related Warning Letters (10)
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2025-03-25
Clinical Investigator
Americo F. Padilla, M.D.
- 2024-11-05
Institutional Review Board (IRB)
Armstrong County Memorial Hospital
- 2024-10-22
Clinical Investigator
Namita A. Goyal, M.D.
- 2024-10-08
Institutional Review Board (IRB)
Louisiana State University Health Science Center IRB
- 2024-07-16
Bioresearch Monitoring Program/IRB
Massachusetts Institute of Technology MIT
- 2024-06-18
Clinical Investigator (Sponsor)
Angela D. Ritter, M.D.
- 2024-03-26
Institutional Review Board (IRB)
New York State Psychiatric Institute IRB
See Also (8)
- Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments (Status: Final)
- Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) (Status: Final)
- Shelf Life of Medical Devices (Status: Final)
- Pharmacogenetic Tests and Genetic Tests for Heritable Markers: Guidance for Industry and FDA Staff (Status: Final)
- Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff (Status: Draft)
- Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff (Status: Final)