Description
For questions about this document regarding CDRH or CBER-regulated devices, contact the CDRH 510(k) Program at510k_program@fda.hhs.govor (301) 796-5640.
Scope & Applicability
Product Classes
6Generally 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.
The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
Medical device intended for small populations
kits requiring specific listing instructions; Specific product category mentioned in guidance resources
devices manufactured in the US for foreign markets
licensed biological products including donor screening tests
Stakeholders
3Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
entity submitting marketing applications
persons affected by prior notice rules
Regulatory Context
Attributes
1Specifications that are directly associated with the intended use of the device.
Related CFR Sections (3)
- 21CFR803.52§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse event reports?
You must include the following information in your reports, if known or reasonably known to you, as described in § 803.50(b) . These types of information correspond generally to the format of Form FDA 3500A:Read 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 →
- 21CFR607.20§ 607.20 Who must register and submit a blood product list.
(a) Owners or operators of all establishments, not exempt under section 510(g) of the act or subpart D of this part , that engage in the manufacture of blood products shall register and submit a list of every blood product in commercial distribution (except that registration and listing information Read full regulation →
Related Warning Letters (4)
- 2024-04-23
CGMP/QSR/Medical Devices/Adulterated
Royal Philips
- 2022-08-09
CGMP/QSR/Medical Devices/Adulterated
InfuTronix LLC
- 2020-07-07
CGMP/QSR/Medical Devices/Adulterated
Luminex Corporation
- 2020-06-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Klarity Medical Products LLC
See Also (8)
- 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)
- Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions: 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)
- In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff (Status: Final)