Description
For questions regarding this document contact Tamara Feldblyum at 301-796-6195 or by email attamara.feldblyum@fda.hhs.gov.
Scope & Applicability
Product Classes
4Validation of certain in vitro diagnostic devices (IVDs) for emerging pathogens; Validation of certain IVD devices for emerging pathogens
should demonstrate at least 90% sensitivity for each analyte
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
Stakeholders
4Entity responsible for submitting NDINs
Special population requiring specific investigation
Assist sponsors in the nonclinical evaluation
Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
5Evidence of a new intended use based on communications
Classification of metallic and calcium phosphate coated orthopedic devices
LoD confirmation criteria
Categorization (minor, moderate, major) for software risk.
Regulatory standard for 510(k) clearance; demonstration required for 510(k) submission; regulatory standard for 510(k) clearance; Comparison of subject device parameters to predicate 510(k) submission numbers.
Identified Hazards
Hazards
4Risk associated with construction, traffic flow, and shared equipment.; Risk from raw food to RTE food or from insanitary objects; Personnel handling RTE foods touch contaminated surfaces
Endogenous and exogenous interference studies
Risk leading to delays in diagnosis and treatment
Risk leading to unnecessary or inappropriate treatment
Related CFR Sections (5)
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
- 21CFR866.3332§ 866.3332 Reagents for detection of specific novel influenza A viruses.
(a) Identification. Reagents for detection of specific novel influenza A viruses are devices that are intended for use in a nucleic acid amplification test to directly detect specific virus RNA in human respiratory specimens or viral cultures. Detection of specific virus RNA aids in the diagnosis ofRead full regulation →
- 21CFR866.3330§ 866.3330 Influenza virus serological reagents.
(a) Identification. Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. InflueRead full regulation →
- 21CFR866.9§ 866.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the casRead 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 →
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.
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-08-26
CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded
Uscom Kft
- 2025-08-12
CGMP/QSR/Medical Devices/Adulterated
Spectra Therapy, LLC
- 2025-08-05
CGMP/QSR/Medical Devices/Adulterated
Mectronic Medicale S.R.L.
- 2025-08-05
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Visgeneer, Inc
- 2025-07-29
CGMP/QSR/Medical Devices/Adulterated
Onkos Surgical, Inc.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
See Also (8)
- Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Suggested Format For IDE Progress Report (Status: Final)
- Design Control Guidance For Medical Device Manufacturers: Guidance for Industry (Status: Final)
- General Principles of Software Validation: Guidance for Industry and FDA Staff (Status: Final)
- Quality System Information for Certain Premarket Application Reviews : Guidance for Industry and FDA Staff (Status: Final)
- Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices: Guidance for Industry and FDA Staff (Status: Final)
- Pharmacogenetic Tests and Genetic Tests for Heritable Markers: Guidance for Industry and FDA Staff (Status: Final)
- Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality: Guidance for Industry (Status: Final)