Deciding When to Submit a 510(k) for a Change to an Existing Device: Guidance for Industry and Food and Drug Administration Staff | Guideline Explorer

Description

Almost from the enactment of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) in 1976, the Food and Drug Administration (FDA or the Agency) has attempted to define with greater clarity when a change in a medical device would trigger the requirement that a manufacturer submit a new premarket notification (510(k)) to the Agency.This documentsupersedes FDA’s guidanceDeciding When to Submit a 510(k) for a Change to an Existing Device (K97-1), issued on January 10, 1997. This guidance is not intended to implement significant policy changes to FDA’s current thinking on when submission of a new 510(k) is required. Rather, the intent of this guidance is to enhance the predictability, consistency, and transparency of the “when to submit” decision-making process by providing a least burdensome approach, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision.

Scope & Applicability

Product Classes

10

In Vitro Diagnostic Devices

Validation of certain in vitro diagnostic devices (IVDs) for emerging pathogens; Validation of certain IVD devices for emerging pathogens

catheter

A manufacturer changes the material of its catheter

dental implant

change from untreated surface to acid-etched; The manufacturer of a dental implant changes the surface

biliary stent

performance characteristics of a biliary stent are critical to safety

ventilator

example of a device where certain features are more critical than others

in vitro diagnostic device

Specific category of medical device mentioned for EUA.

urinary drainage (Foley) catheter

example of a device undergoing a length change; change in length of the catheter

IVD

Example 6: In vitro diagnostic for Candida species susceptibility

IVD reagent

In vitro diagnostic product mentioned in compatibility examples

Daily Wear Contact Lenses

specific guidance for changes to daily wear contact lenses

Stakeholders

7

manufacturer

Entity 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.

510(k) Holder

The person who possesses the 510(k) clearance for a device.

lay users

intended users in an over-the-counter use scenario

knowledgeable individual

person reviewing chemical composition differences

material supplier

entity providing materials for device manufacturing

Private label distributors

Exempt from 510(k) if satisfying specific requirements

Remanufacturer

Entity that significantly changes finished device performance

Regulatory Context

Attributes

10

shelf-life

An increase in this attribute generally does not require a new 510(k) if protocols are met.

Material Formulation

Base formulation of a polymer or alloy plus additives.

Expiration Date

Property of a device that may be changed via established protocols

expiration dating

change in packaging or expiration dating

chemical formulation

polymer B has a different chemical formulation

probability of occurrence

Factor used to assess the likelihood of a hazard.

severity of harm

factor in determining whether a device change significantly affects safety

chemical composition

material in question should have the same formulation or chemical composition

biocompatibility

Could the change significantly affect the performance or biocompatibility of the device?; Property of packaging material evaluated after supplier change; determine if processing could affect the biocompatibility of the device

single-use

whether the device is provided for single-patient, single-use.; A device that is intended for one use or on a single patient during a single procedure

Identified Hazards

Hazards

10

Adverse events

Unexpected safety issues identified postmarket

harm

The combination of the probability of occurrence of harm and the severity of that harm

embolic risk

Risk associated with rusting components in guidewires.

rusting

there have been no issues with rusting (which could introduce embolic particles)

biocompatibility risks

The risk assessment identifies that the new formulation presents a new biocompatibility risk.

thermal injury

severity of potential thermal injury increased with higher-powered heater

stent fracture

risk identified in biliary stent material change

stent migration

risk identified in biliary stent material change

false negative results

Risk identified in IVD performance degradation

false positive results