Description
FDA is issuing this draft guidance to provide our current thinking on the use of clinical data in 510(k) submissions to enhance the predictability, consistency, and transparency of the 510(k) Program. FDA developed this draft guidance in response to public feedback, and to continue to modernize the framework for 510(k) review. The recommendations in this draft guidance are consistent with “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” guidance, and provide additional clarity and context for situations when clinical data may be necessary to demonstrate substantial equivalence. The recommendations are intended to advance safety and innovation as well as promote consistency and facilitate efficient review of 510(k) submissions that include clinical data.
Scope & Applicability
Product Classes
5Products 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.
Diagnostic devices with specific clinical data needs
Example 6: In vitro diagnostic for Candida species susceptibility
Devices providing anatomic support
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
Stakeholders
2A legally marketed device used for comparison in a 510(k)
Entity responsible for submitting NDINs
Regulatory Context
Attributes
5conformity with an FDA-recognized standard can help demonstrate that an NGS-based test developer has performed the activities necessary to identify the indications for use; number and types of samples used in the study should be statistically justified for the test’s indications for use; If a modification expands the indications for use beyond aiding in the diagnosis of symptomatic individuals; Acceptable performance levels depend on these
materials, design, and energy source of the device
Evidence of a new intended use based on communications
The overall evaluation of a product's benefits versus its risks
Standard for 510(k) clearance
Identified Hazards
Hazards
3Newly identified risk for the predicate device
Probable risk weighed against benefit
Unexpected safety issues identified postmarket
Related CFR Sections (2)
- 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 →
- 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 →
Related Warning Letters (10)
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
- 2025-08-05
CGMP/QSR/Medical Devices/Adulterated
Mectronic Medicale S.R.L.
- 2025-07-15
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
WHOOP, Inc.
- 2025-05-27
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
DRG Instruments GmbH
- 2025-03-25
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Rex Implants Inc.
- 2024-09-10
CGMP/QSR/Medical Devices/Adulterated
Optikem International, Inc.
- 2024-08-28
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Shenzhen Moyeah Intelligent Life Technology Co.
- 2024-08-28
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Adventure Innovations LLC
- 2024-08-28
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Natures Pillows, Inc. and Top Dog Direct, LLC
- 2024-08-13
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Baylab USA, LLC
See Also (8)
- Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Medical Device Accessories - Describing Accessories and Classification Pathways: Guidance for Industry and FDA Staff (Status: Final)
- Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff (Status: Final)
- Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications: Guidance for Industry and Food and Drug Administration Staff (Status: Final)