Description
The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a premarket notification (510(k)) submission meets a minimum threshold of acceptability and should be accepted for substantive review. Focusing FDA’s review resources on complete submissions will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible.
Scope & Applicability
Product Classes
5FDA 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
IVD device clinical studies conducted on de-identified specimens
Specific category of medical device mentioned for EUA.
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.
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
5FDA staff member responsible for initial screening
A signed statement by the manufacturer's designated individual(s)
Entity responsible for submitting NDINs
Person to whom the RTA checklist and Addendum are sent
The entity providing information for the AFIC process.
Regulatory Context
Attributes
10Threshold for a submission to be accepted for review; Requirement for a submission to be accepted for review
Quality parameter that must remain unchanged for the policy
Performance characteristics including Analytical specificity
Analysis by sex of clinical performance measures such as sensitivity
Performance characteristic assessed via linearity experiment
Closeness of agreement between a series of measurements from multiple samplings.; Performance characteristic measured by intermediate precision; Performance characteristic to be validated
Categorization (minor, moderate, major) for software risk.
Property of a device that may be changed via established protocols
Premarket submission recommendation section; Device property; increase may not require new 510(k)
Labeling claim for medical devices
Identified Hazards
Hazards
4Device types identified in the Reprocessing FR Notice devices posing a greater likelihood of microbial transmission
Summary of the known and potential risks and benefits, if any, to human participants.
Risk of device functionality being compromised
represent a high risk of infection
Related CFR Sections (14)
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR809.10§ 809.10 Labeling for in vitro diagnostic products.
(a) The label for an in vitro diagnostic product shall state the following information, except where such information is not applicable, or as otherwise specified in a standard for a particular product class or as provided in paragraph (e) of this section. Section 201(k) of the act provides that “a Read full regulation →
- 21CFR58.185§ 58.185 Reporting of nonclinical laboratory study results.
(a) A final report shall be prepared for each nonclinical laboratory study and shall include, but not necessarily be limited to, the following:Read full regulation →
- 21CFR58.120§ 58.120 Protocol.
(a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. The protocol shall contain, as applicable, the following information:Read full regulation →
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
- 21CFR801.1§ 801.1 Medical devices; name and place of business of manufacturer, packer or distributor.
(a) The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.Read full regulation →
- 21CFR801.5§ 801.5 Medical devices; adequate directions for use.
Adequate directions for use means directions under which the layman can use a device safely and for the purposes for which it is intended. Section 801.4 defines intended use. Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specificatiRead full regulation →
- 21CFR872.3710§ 872.3710 Base metal alloy.
(a) Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.Read full regulation →
- 21CFR812.28§ 812.28 Acceptance of data from clinical investigations conducted outside the United States.
(a) Acceptance of data from clinical investigations conducted outside the United States to support an IDE or a device marketing application or submission (an application under section 515 or 520(m) of the Federal Food, Drug, and Cosmetic Act, a premarket notification submission under section 510(k) Read full regulation →
- 21CFR812.3§ 812.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. 1040 et seq., as amended ( 21 U.S.C. 301-392 )).Read full regulation →
- 21CFR807.93§ 807.93 Content and format of a 510(k) statement.
- 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 →
- 21CFR3.2§ 3.2 Definitions.
For the purpose of 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
- 2025-09-09
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.
- 2025-08-12
CGMP/QSR/Medical Devices/Adulterated
Spectra Therapy, LLC
- 2025-08-05
CGMP/QSR/Medical Devices/Adulterated
Mectronic Medicale S.R.L.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-06-24
CGMP/QSR/Medical Devices/Adulterated
Aju Pharm Co., Ltd.
- 2025-05-27
CGMP/QSR/Medical Devices/Adulterated
Sedecal S.A.
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)