Description
FDA developedthis documentto provide guidance to industry and FDA staff about current review practices for premarket notification (510(k)) submissions. The intent of this guidance is to identify, explain, and clarify each of the critical decision points in the decision-making process FDA uses to determine substantial equivalence. This guidance is not intended to implement significant policy changes to the current 510(k) review process. Rather, the intent of this guidance is to enhance the predictability, consistency, and transparency of the 510(k) program by describing in greater detail the regulatory framework, policies, and practices underlying FDA’s 510(k) review.
Scope & Applicability
Product Classes
10General manual surgical instruments exempt from 510(k)
Eligible when disease affects not more than 8,000 individuals/year
Eligible based on number of individuals subjected to diagnosis
IVDs mentioned regarding clinical decision-making impact
The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
Class III subject to the 510(k) or PMA requirements
Low risk medical devices
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
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.
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
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
5Evidence of a new intended use based on communications
The software for this device was considered as a major level of concern
conformity 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
Standard for 510(k) clearance
Identified Hazards
Hazards
1risk associated with complex ablation lesion sets
Related CFR Sections (7)
- 21CFR876.1500§ 876.1500 Endoscope and accessories.
(a) Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optRead full regulation →
- 21CFR807.92§ 807.92 Content and format of a 510(k) summary.
(a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substantial equivalence. All 510(k) summaries shall conRead full regulation →
- 21CFR807.100§ 807.100 FDA action on a premarket notification.
(a) After review of a premarket notification, FDA will: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 →
- 21CFR814.20§ 814.20 Application.
(a) The applicant or an authorized representative shall sign the PMA. If the applicant does not reside or have a place of business within the United States, the PMA shall be countersigned by an authorized representative residing or maintaining a place of business in the United States and shall identRead full regulation →
- 21CFR814.104§ 814.104 Original applications.
(a) United States applicant or representative. The applicant or an authorized representative shall sign the HDE. If the applicant does not reside or have a place of business within the United States, the HDE shall be countersigned by an authorized representative residing or maintaining a place of buRead full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
Related Warning Letters (10)
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
CCIC Huatongwei International Inspection Co., Ltd.
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Jiangsu Kerbio Medical Technology Group Co.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2025-03-25
Clinical Investigator
Americo F. Padilla, M.D.
- 2024-11-05
Institutional Review Board (IRB)
Armstrong County Memorial Hospital
- 2024-10-22
Clinical Investigator
Namita A. Goyal, M.D.
- 2024-10-08
Institutional Review Board (IRB)
Louisiana State University Health Science Center IRB
- 2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Mid-Link Testing Company, Ltd
See Also (8)
- 510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments (Status: Final)
- CPG Sec. 370.100 Cytotoxic Testing for Allergic Diseases (Status: Final)
- Guidance Document For Washers And Washer-Disinfectors Intended For Processing Reusable Medical Devices (Status: Final)
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Surgical Staplers and Staples for Internal Use - Labeling Recommendations: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation: Guidance for Industry (Status: Final)