510 K Medical Device Classification

Classify Your Medical Device | FDA

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

Each classification panel in the CFR begins with a list of devices classified in that panel. Each classified device has a 7-digit number associated with it, e.g., 21 CFR 880.2920 - Clinical...

510(k) Clearances | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/510k-clearances

Section 510 (k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device …

Content of a 510(k) | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/premarket-notification-510k/content-510k

Premarket Notification 510(k) | FDA

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k

A 510 (k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and …

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

A 510 (k) must demonstrate that the device is substantially equivalent to one legally in commercial distribution in the United States: (1) before May 28, 1976; or (2) to a …

Search the Releasable 510(k) Database | FDA

https://www.fda.gov/medical-devices/510k-clearances/search-releasable-510k-database

Device Classification Name: Regulation Number: 510 (k) Number: Device Name: Applicant: Contact: Product Code: Date Received: Decision Date: Decision: Classification Advisory …

Product Classification - Food and Drug Administration

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm

Product Classification FDA Home Medical Devices Databases This database includes: a list of all medical devices with their associated classifications, …

510(k) Submission Process | FDA

https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process

Starting October 1, 2023, all 510 (k) submissions, unless exempted (as described in Section VI.A of the final guidance, Electronic Submission Template for …

Medical Device Exemptions 510(k) and GMP Requirements

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/315.cfm

Introduction. Following is a breakdown of 510 (k) exempt and Good Manufacturing Practice (GMP)/Quality System exemptions listed by device class. All devices in this …