Patient Preference Information - Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders

Description

The U.S. Food and Drug Administration (FDA or the Agency) values the experience and perspectives of patients. The Agency understands that patients and care-partners who live with a disease or condition on a daily basis and utilize devices in their care may have developed their own insights into and perspectives on the benefits and risks of devices reviewed under the premarket approval, humanitarian device exemption (HDE), orde novoclassification pathway. FDA believes that patients can and should bring their own experiences to bear in helping the Agency evaluate the benefit-risk profile of certain devices.

Scope & Applicability

Regulatory Context

• 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 →

• 21CFR814.82§ 814.82 Postapproval requirements.

  (a) FDA may impose postapproval requirements in a PMA approval order or by regulation at the time of approval of the PMA or by regulation subsequent to approval. Postapproval requirements may include as a condition to approval of the device:Read 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 →

• 21CFR812.140§ 812.140 Records.

  (a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator's participation in an investigation: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 →

• Bioresearch Monitoring Program/Institutional Review Board (IRB)

  United Health Products, Inc.

  2025-05-20

• Bioresearch Monitoring Program/IRB

  Massachusetts Institute of Technology MIT

  2024-07-16

• Investigational Review Board (IRB)

  Nobles Medical Technology II, Inc.

  2024-03-12

• CGMP/QSR/Medical Devices/Misbranded

  Wello Inc.

  2023-11-14

• CGMP/QSR/Medical Devices/Adulterated

  Synovo Production, Inc.

  2023-04-04

• Investigational Device Exemptions (Clinical Investigator)

  Kennedy, Philip R.

  2020-04-07

• Premarket Approval Application and Humanitarian Device Exemption Modular Review: Guidance for Industry and FDA Staff (Status: Final)
• Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process: Guidance for Industry and FDA Staff (Status: Final)
• Principles of Premarket Pathways for Combination Products: Guidance for Industry and FDA Staff (Status: Final)
• Center for Devices and Radiological Health (CDRH) Appeals Processes: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
• Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
• 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)