Description
This draft guidance document provides the FDA’s recommendations on the human factors information that should be documented and included in medical device marketing submissions, when such are required. The recommendations are intended to promote consistency and facilitate efficient review of medical device submissions.
Scope & Applicability
Product Classes
7FDA 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
New portable fingertip oximeter intended for spot checking oxygen saturation.
Approved PMA for a stent with a balloon catheter delivery system.
An implantable infusion pump has a physician programmer.
device intended for use in hospital environments; Scenario involving changing the GUI of the gas machine for anesthesia.
computer-assisted detection device used in endoscopy
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Stakeholders
5Entity responsible for submitting NDINs
individual receiving expanded access treatment; The individual receiving the investigational treatment and providing consent.
medical professional requesting HCT/P for urgent need; requesting HCT/P based on urgent medical need
The entity providing information for the AFIC process.
User population that might train lay users or perform specific tasks.
Regulatory Context
Attributes
6Tasks identified during human factors assessment; Tasks which, if performed incorrectly, could lead to serious harm.
Recommended HF information in this marketing submission.
Recommended HF information in this marketing submission.; The recommended HF Submission Category in this marketing submission
Recommended HF information in this marketing submission.
User tasks which, if performed incorrectly, could cause harm.
Overall risk remaining after risk control measures have been implemented
Identified Hazards
Hazards
4hazards related to human-automation interactions and cognitive limitations
cause serious harm to the user/patient
Potential errors that may occur during product use tasks.
intentional act or intentional omission of an act that reflects violative or reckless use
Related CFR Sections (4)
- 21CFR876.1520§ 876.1520 Gastrointestinal lesion software detection system.
(a) Identification. A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in tRead full regulation →
- 21CFR803.3§ 803.3 How does FDA define the terms used in this part?
Some of the terms we use in this part are specific to medical device reporting and reflect the language used in the statute (law). Other terms are more general and reflect our interpretation of the law. This section defines the following terms as used in this part:Read full regulation →
- 21CFR807.81§ 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →
- 21CFR814.39§ 814.39 PMA supplements.
(a) After FDA's approval of a PMA, an applicant shall submit a PMA supplement for review and approval by FDA before making a change affecting the safety or effectiveness of the device for which the applicant has an approved PMA, unless the change is of a type for which FDA, under paragraph (e) of thRead full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
- 2025-08-26
CGMP/QSR/Medical Devices/Adulterated
Miach Orthopaedics
See Also (8)
- Medical Device Reporting for User Facilities (Status: Final)
- Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Safer Technologies Program for Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Electromagnetic Compatibility (EMC) of Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Off-The-Shelf Software Use in Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 130.400 Use of Microfiche and/or Microfilm for Method of Records Retention (Status: Final)
- CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections (Status: Final)