Medical Device Regulation Basics: US FDA 510(k) 21 CFR 807

A 510(k) is a Premarket Notification which demonstrates that device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.

Section 510(k) of Federal FD&C Act

Predicate: The legally marketed device(s) to which equivalence is drawn.

It is a marketing clearance application. 21 CFR 807 Subpart E describes requirements for a 510(k) submission. There is no 510(k) form.

This submission is mostly for class II and some class I devices. Few class III devices which is not subject to PMA may require 510(k)

Substantial Equivalence (SE)

Manufacturer needs to compare their device characteristics (intended use and technological characteristics) with predicate to determine the substantial equivalence.

Both Type I & Type II scenarios are considered as substantially equivalent.

Characteristics	Device to be marketed	Legally marketed device (Predicate)
Type I
Intended use	Same	Same
Technological characteristics	Same	Same
Type II
Intended use	Same	Same
Technological characteristics*	Different	Different
*submit an information to FDA to demonstrate that the device is at least as safe and effective as the legally marketed device

Types of 510(k)

Traditional 510(k)

Most common type and used under any circumstances.
It may be used for any original 510(k) or for a modification to a previously cleared device under 510(k).
The traditional method is the original complete submission as provided in 21 CFR 807.

Click here to get the Format for Traditional and Abbreviated 510(k)s:

Special 510(k)

Submitted for a modification to a device cleared under the 510(k) process (usually modification of own legally marked device).
Modification does not affect the device’s intended use or alter its fundamental scientific technology
Design controls and risk analysis of device modification used to clear the 510(k)

Abbreviated 510(k)

If the device has any FDA guidance documents, special control(s) for the device type, or voluntary consensus standard(s) then abbreviated 510(k) is preferred.

Common 510(k) submission documents are listed below,

Medical Device User Fee Cover Sheet (Form FDA 3601)
Center for Devices and Radiological Health (CDRH) Premarket Review Submission Cover Sheet (Form FDA 3514)
510(k) Cover Letter
Indications for Use Statement (Form FDA 3881)
510(k) Summary or 510(k) Statement
Truthful and Accuracy Statement
Class III Summary and Certification
Financial Certification or Disclosure Statement
Declarations of Conformity and Summary Reports
Proposed Labeling
Sterilization and Shelf Life
Biocompatibility
Software
Electromagnetic Compatibility and Electrical Safety
Performance Testing – Bench
Performance Testing – Animal
Performance Testing – Clinical

510(K) application also includes below information,

Device Description
Executive Summary/Predicate Comparison
Substantial Equivalence Discussion

Documents issued by FDA for product 510(k) clearance

After FDA 510(k) clearance, manufacturer will receive Substantial Equivalence (SE) Letter and 510(k) Summary (if provided instead of 510(k) Statement)

The following are posted on the FDA’s public 510(k) database:

Substantial Equivalence (SE) Letter
Indications for Use Form
510(k) Summary (if provided instead of 510(k) Statement)

FDA Review – 90 days for traditional /abbreviated 510(k),30 days for special 510(k)

1.Sponsor submits the ecopy to FDA CDRH's or CBER’s Document Control Center (DCC). FDA will send the acknowledgement letter or hold letter if there is any issues with ecopy or user fees (7days)

2.FDA Acceptance Review: Administrative review to assess the completeness of the application.

Manufacturer can use Refuse to AcceptPolicy for 510(k)s:

Within 15 calendar days FDA will notify below to manufacturer:

Request accepted for substantive review;
Not been accepted for review (i.e., considered refused to accept RTA -Manufacturer shall address within 180 days
Request is under substantive review and the FDA did not complete the acceptance review within 15 calendar day

3. Substantive Review (60 days): Lead reviewer will assess the application and share the below information to manufacturer

Interactive review
Additional Information letter .510(k) request will be placed on hold. Manufacturer shall address within 180 days

3.510(k) decision(90 days): MDUFA(medical device user fee amendments) Decision

Substantial Equivalence (SE) Decision: Device 510(k) Cleared. Market the device
Non-Substantial Equivalence (NSE) Decision: Device not 510(k) Cleared. Resubmit another 510(k) with new data, PMA, de novo or reclassification petition