Description
The purpose of this guidance is to establish procedures for submitting, reviewing, and responding to requests for information regarding the class in which a device has been classified or the requirements applicable to a device under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that are submitted in accordance with section 513(g) of the FD&C Act. This guidance was updated to provide information regarding the voluntary submission of 513(g) Requests through the electronic Submission Template And Resource (eSTAR).
Scope & Applicability
Product Classes
10Low 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.
Products subject to additional FDA requirements
appears to be an unclassified pre-amendments device type
appears to be a post-amendments device type that has not yet been reclassified
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
Class III subject to the 510(k) or PMA requirements
Stakeholders
1Sponsor or applicant requesting a formal meeting.; The party submitting the meeting request; The entity responsible for submitting the meeting package and attending the meeting.
Related CFR Sections (3)
- 21CFR860.3§ 860.3 Definitions.
For the purposes of this part:Read full regulation →
- 21CFR860.84§ 860.84 Classification procedures for “preamendments devices.”
(a) This subpart sets forth the procedures for the original classification of a generic type of device that was in commercial distribution before May 28, 1976. Such a device will be classified by regulation into either class I (general controls), class II (special controls) or class III (premarket aRead full regulation →
- 21CFR3.2§ 3.2 Definitions.
For the purpose of this part:Read full regulation →
See Also (8)
- Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff (Status: Final)
- Bundling Multiple Devices or Multiple Indications in a Single Submission: Guidance for Industry and FDA Staff (Status: Final)
- Custom Device Exemption: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- 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)