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FDA Guidance Document: 

“Distinguishing Medical 

Device Recalls from Medical 

Device Enhancements”

Ron Brown

Chief, Recall Branch

Division of Analysis and Program Operations 

Office of Compliance

Center for Devices and Radiological Health

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Objectives

• Emphasize that the key factor in distinguishing a medical 

device recall from an enhancement is the existence of a 

violation of the Food Drug and Cosmetic Act (FD&C Act)

• Understand that correctly categorizing a change to a device 

as a recall or an enhancement impacts the applicability and 

nature of industry responsibilities and FDA oversight

• Provide guidance and examples to facilitate the decisionmaking process for when a Report of Correction and Removal 

(806 report) to the Center for Devices and Radiological 

Health (CDRH) would be necessary

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Feedback from Industry

• Concerns about making modifications to devices

– Does enhancing a device cause existing devices to 

become violative?

– Will the FDA request a recall?

– When is a change an enhancement and when is it a 

recall?

– What needs to be reported to the FDA?

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Comments on Draft Guidance

1. Clarification of definitions; 

2. Request for more examples; and

3. Clarification of reporting obligations pertaining to 

Medical Device: Reports of Corrections and Removals 

(21 CFR Part 806)

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Recurring Themes – Public 

Comments on Draft Guidance

• Stock recovery

• Increase number of 

examples given

• Remove flowchart 

• Withdraw guidance

• Point of use 

• Rulemaking

• Subjective

• Applicability to future 

devices 

• Technical violations

14 responses (containing 111 comments) were received: 

4 from trade associations, 10 industry 6
Key Points

This guidance is intended to: 

1. Clarify when a change to a device constitutes a 

medical device recall, 

2. Distinguish those instances from device enhancements 

that do not meet the definition of a medical device 

recall, and 

3. Clarify reporting requirements under Medical Device: 

Reports of Corrections and Removals (21 CFR Part 806)

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Important factors

• It is important to note that this guidance does not alter 

our current expectations regarding medical device 

recalls

• It applies to medical devices regulated by CDRH, 

whether or not devices require or are exempt from 

premarket review

• This guidance seeks to address concerns that firms 

may have about making enhancements

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Factors that do not apply

This guidance does not address and does not apply to:

• Whether a new premarket submission is required

• Radiation-emitting electronic product defects or 

failures to comply with radiation safety performance 

standards contained in 21 CFR Parts 1020 to 1050

• Methodologies for risk management or risk assessment

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Recall Definition

• As defined at 21 CFR 7.3(g), “recall means a firm's 

removal or correction of a marketed device that the 

Food and Drug Administration considers to be in 

violation of the laws it administers and against which 

the agency would initiate legal action, e.g., seizure. 

Recall does not include a market withdrawal or a stock 

recovery.” 

• Recall does NOT include routine servicing. 

• Recall also does NOT include an enhancement, as 

defined by this guidance.

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Enhancement Definition

• A device enhancement is 

– (1) a change to improve the performance or quality 

of a device; that is 

– (2) not a change to remedy a violation of the FD&C 

Act. Device enhancements include, but are not 

limited to, changes designed to better meet the 

needs of the user, changes to make the device 

easier to manufacture, changes to improve the 

device’s safety or performance, and changes to the 

appearance of the device that do not affect its use.

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Recall Identification

Firms should consider:

• Is your product a device? 

• Why are you considering making a change to your 

device?

• Are you currently marketing the device to which you 

are considering or making changes? 

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What is the Violation?

• The key factor in distinguishing a medical device recall 

from an enhancement is the existence of a violation of 

the FD&C Act. 

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Differentiating Violative Devices 

from Non-Violative Devices

• Are the changes intended to resolve a failure to meet 

specifications or failure of the device to perform as 

intended?

• Is the labeling for the device to which you are 

considering making changes false or misleading; does it 

fail to have adequate directions for use; or does it 

otherwise violate the FD&C Act or FDA regulations?

• Are you otherwise out of compliance with FDA 

regulations?

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806 Reporting Requirements

• Medical device enhancements do not require the 

submission of an 806 report

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Other Regulatory Considerations 

• Once a determination has been made, whether the 

change represents a medical device recall or an 

enhancement, additional regulatory obligations should 

be considered. 

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Comparison Example #1

Recall

• An in vitro diagnostics (IVD) device firm markets a test to detect 

the level of a specific antigen in blood. The device represents 95% 

sensitivity to the specific antigen. 

• Two years after initial marketing, the firm determines that the 

device sensitivity to the specific antigen, as manufactured, has 

decreased to 90%, thus not meeting performance specifications 

and making the device violative. 

• As a result, the firm modifies the product in the field to “improve” 

the sensitivity from 90% to 95%. Because the firm’s actions are 

returning the product to the quality it was represented to possess, 

FDA would generally consider these actions a recall.

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Comparison Example #1

Enhancement

• An IVD device firm markets a test to detect the level of a specific 

antigen in blood. The device is represented to have 95% sensitivity 

to the specific antigen.

• Two years after initial marketing, the firm modifies the product to 

improve the sensitivity to the antigen from 95% to 98%. This 

modification is determined to be an improvement to the safety 

and effectiveness of the device, and is determined to be unrelated 

to any known device violation. 

• FDA would generally regard this action as a device enhancement, 

although it may require a regulatory submission.

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Comparison Example #2

Recall

• Shortly after launch, the ergonomics of a marketed electrosurgical 

unit device are determined to be less-than-optimal, in that users 

have reported difficulty guiding the hand piece and the firm has 

received reports of serious injury associated with its use. 

• The firm’s investigations reveal that difficulty guiding the hand 

piece contributes to the serious injuries and that the hand piece is 

not performing as represented. 

• The firm replaces all the hand pieces in the field and on all units 

currently in inventory, to eliminate the possibility of serious harm. 

• FDA would generally consider these actions a recall.

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Comparison Example #2

Enhancement

• A firm markets a new electrosurgical unit device. Shortly after 

launch, the ergonomics of the hand-piece of the newly-marketed 

device are determined to be difficult to use. 

• The firm determines that this difficulty does not change the risk of 

the device and no violations of the FD&C Act or regulations are 

identified.

• The firm develops and incorporates a new hand piece into the 

electrosurgical unit device. 

• FDA would generally consider this action to be a device 

enhancement, although it may require a regulatory submission.

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Summary

• Correctly categorizing medical device recalls and medical 

device enhancements:

– amplifies the likelihood that firms will appropriately determine 

when 806 reports to CDRH are and are not necessary; and 

– increases the likelihood that FDA will concur with industry 

decisions regarding reporting obligations.

• The guidance: 

– provides added clarity to regulatory terms and definitions 

specific to medical device recalls and enhancements; and

– does not intend to address the comprehensive obligations 

related to medical device recalls. 

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Questions?

For general questions, contact the Division of Industry and 

Consumer Education: DICE@fda.hhs.gov

For more specific questions, please contact your district 

office: 

http://www.fda.gov/safety/recalls/industryguidance/ucm129

334.htm

Slide Presentation, Transcript and Webinar Recording will be 

available at:

www.fda.gov/CDRHWebinar under the “Past Webinars and 

Stakeholder Calls-2014” tab.

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