Description
FDA has developed thisguidance documentto provide clarity for FDA staff and industry regarding the benefit and risk factors FDA may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality1 and patient safety. This guidance is not intended to limit FDA action; rather, it describes the general framework for medical device decision making in the product availability, compliance, and enforcement arenas. Product availability and other medical device compliance and enforcement decisions are generally fact-specific. However, FDA believes that explaining how we consider the factors listed in this guidance document will improve the consistency and transparency of these kinds of decisions. A common understanding of how FDA considers benefit and risk may better align industry’s and FDA’s focus on actions that maximize benefit to patients, improve medical device quality, and reduce risk to patients.
Scope & Applicability
Product Classes
10FDA 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
High benefit device intended for posterior, non-cervical pedicle fixation
Low benefit, low additional risk device example
Recall of a radiation therapy device with high benefit
A biological indicator used in monitoring hospital steam sterilization
A drug delivery system was developed that included a safety feature
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.
Devices subject to benefit-risk assessment; Risk factors for false-positive or false-negative results; Devices providing false-positive or false-negative results
Devices subject to benefit-risk assessment
Implications of 21 CFR 801.109 for final labeling
Stakeholders
7Entity responsible for submitting NDINs
Way questions are framed is critical to collecting unbiased patient input
Individuals providing information for medical product development; Participants in facilitated discussions and observational studies
Intended users in professional settings.; Users who must adhere to standard precautions.
FDA point of contact for recall situations
Provides clinical judgment and conducts assessments for ClinROs.
User population that might train lay users or perform specific tasks.
Regulatory Context
Attributes
9Degree to which patients experience treatment benefit
A factor considered in enforcement decisions based on past 2, 5, or 10 years.
Scope of compliance and enforcement decisions
Used to assess proportion of patients observed to benefit
Specific method or type of failure
Ability to screen for or monitor the serious adverse event
Level of concern patients have regarding harm
Considers potential number of patients at risk
component of the definition of risk
Identified Hazards
Hazards
7Evaluation depends on the probable risk of death or serious injury.
Nonconformity in the device
Specific technical failure anticipated by manufacturer; The underlying cause of a device issue identified by the manufacturer.
Events reported without harm but indicating risk
Risk identified for a specific subgroup of patients
Risk factor for diagnostics leading to missed treatment
Risk factor for diagnostics leading to unnecessary treatment
Related CFR Sections (8)
- 21CFR820.1§ 820.1 Scope.
(a) Applicability. Current good manufacturing practice (CGMP) requirements are set forth in this quality management system regulation (QMSR). The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, insRead full regulation →
- 21CFR7.3§ 7.3 Definitions.
(a) Agency means the Food and Drug Administration.Read full regulation →
- 21CFR820.3§ 820.3 Definitions.
The definitions in ISO 13485 and in Clause 3 of ISO 9000 (incorporated by reference, see § 820.7 ) apply to this part, except as specified in paragraph (b) of this section, and do not affect the meaning of similar terms defined in this title.Read full regulation →
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part: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 →
- 21CFR801.4§ 801.4 Meaning of intended uses.
The words intended uses or words of similar import in §§ 801.5 , 801.119 , 801.122 , and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the designRead 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 →
- 21CFR806.10§ 806.10 Reports of corrections and removals.
(a) Each device manufacturer or importer shall submit a written report to FDA of any correction or removal of a device initiated by such manufacturer or importer if the correction or removal was initiated: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
- 2025-09-30
Medical Device Reporting/Misbranded
Insung Medical Co. Ltd.
- 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.
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)