Description
FDA has developed thisguidance documentto provide greater clarity for FDA reviewers and industry regarding the principal factors FDA considers when making benefit-risk determinations during the premarket review process for certain medical devices. FDA believes that the uniform application of the factors listed in this guidance document will improve the predictability, consistency, and transparency of the premarket review process.
Scope & Applicability
Product Classes
9FDA 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
Used for patient management or selection in a clinical trial
Category of device associated with specific known risks
Specific labeling and performance testing requirements for IVDs
replaces a patient's memory to treat Alzheimer's disease
Devices addressing unmet medical needs
General manual surgical instruments exempt from 510(k)
The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.
Stakeholders
7Entity responsible for submitting applications under section 524B
Individuals providing information for medical product development; Participants in facilitated discussions and observational studies
User population that might train lay users or perform specific tasks.
Perspectives considered when PPI is not feasible; care-partner perspectives may be considered in circumstances where it is not feasible to obtain PPI; care-partner perspectives may be considered in circumstances where it is not feasible to obtain PPI.
Entity responsible for submitting NDINs
specially trained professionals required for implantation
Risk mitigation by requiring implantation by specialized personnel
Regulatory Context
Attributes
10Risk that no set of reasonable patients would be willing to endure; Assessment of whether benefits outweigh the risks.
Requirement for eligibility for the accelerated approval pathway.
Factor taken into consideration for meaningful clinical assessment
A favorable change in clinical assessment meeting this threshold; favorable change in at least 1 clinical assessment that meets or surpasses a minimally important clinical difference
Assessment of whether a clinical benefit is demonstrated for the device; assessment of the clinical benefit; Is there any evidence of clinical benefit for a modified Indications for Use?; Tipping point and/or worst-case sensitivity analysis continuing to show clinical benefit.
The overall evaluation of a product's benefits versus its risks
Uncertainty should be included in the performance specifications for all quantitative imaging functions
Level demonstrated for the cleared device; Core regulatory standard for assay performance
Ability to detect intended mechanism of action without interference; Performance characteristic to be validated
Analysis by sex of clinical performance measures such as sensitivity
Identified Hazards
Hazards
8Risk for diagnostics leading to unnecessary treatment
Risk associated with permanent implantable devices
Risk associated with permanent implantable devices
lower the probability of a harmful event occurring
Unexpected safety issues identified postmarket
the possibility of device fracture (which was not predicted in any of the bench and animal testing).; Risk associated with permanent implantable devices
8% risk from surgery alone; Serious adverse events include partial paralysis, loss of vision, loss of motor skills, vertigo, and insomnia.; requiring the labeling to prominently address the 8% serious adverse event rate; Risks such as device-related fractures or complications
Risk for diagnostics leading to missed treatment
Related CFR Sections (3)
- 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 →
- 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 →
- 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 →
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)
- Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k)) (Status: Final)
- CPG Sec. 350.100 Packaging Technologies and Tamper-Resistant Packaging Requirements for Contact Lens Solutions and Tablets (Status: Final)
- CPG Sec. 310.100 Pacemaker Reuse (Status: Final)
- Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k) (Status: Final)
- Kit Certification for 510(k)s (Status: Final)
- Immunotoxicity Testing Guidance (Status: Final)
- Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment C: Specific Instructions for Sunlamp Product Inspections and Tests (Status: Final)