FDA/Healthcare Practice Group
September 13, 2007
FDA Uses New Health Hazard Evaluation (HHE) Form
to Classify Recalls
Attached is the Food and Drug Administration’s (FDA) new Health
Hazard Evaluation (HHE) form for classifying recalls as Class I, II or
III. Previously, FDA used a numerical rating system to determine a
recall’s classification. The new HHE form, however, utilizes a more
subjective system. Recent experience suggests that FDA is taking a
more conservative approach in classifying recalls under the new HHE
system, especially with regard to Class I recalls.
The form is available on the website of the Office of In Vitro
Diagnostic Devices Evaluation and Safety and can be accessed at
www.fda.gov/cdrh/oivd/hheform.html. Please note that although the
form appears on the OIVD website, CDRH will be using it for all
devices. Therefore, we recommend that all medical device companies
utilize this form when making their own health hazard evaluations and
classifying recalls.
■
For more information, contact:
■
■
For more information about FDA’s new approach for classifying
recalls, please contact Ed Basile at (202) 626-2903.
Edward M. Basile
202.626.2903
[email protected]
King & Spalding
Washington, D.C.
1700 Pennsylvania Avenue, NW
Suite 200
Washington, D.C. 20006
Phone: 202.737.0500
Fax: 202.626.3737
www.kslaw.com
King & Spalding is an international law firm with more than 800 lawyers in Atlanta, Charlotte, Dubai,
Frankfurt, Houston, London, New York, Riyadh and Washington, D.C. The firm represents half of the
Fortune 100, and in a Corporate Counsel survey in September 2007 was among the top firms representing
Fortune 250 companies. For additional information, visit www.kslaw.com.
This alert provides a general summary of recent legal developments. It is not intended to be and should not
be relied upon as legal advice.
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OIVD: Health Hazard Evaluation Form
Page 1 of 5
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HHE Version 3-1 01/12/2007
Health Hazard Evaluation [ ]
or Health Risk Assessment [ ]
Center for Devices and Radiological Health
• New OIVD Products
(since 8/1/2007)
• All OIVD Products
• 510(k) Database
• PMA Database
• CLIA Database
• Home use/OTC tests
• IVD Guidances
• IVD Standards
• CeSub Turbo 510(k)
eSubmissions
Date:
RES #:
Consumer Safety Officer:
I. Product Data
Device Name:
Panel Code:
Product Code:
Model:
Lot/Serial Numbers:
Marketing Status (Include 510(K) Or PMA Number, Specify If Class I
Exempt From 510(K) :
Total Number Of Devices In Distribution:
U.S.:
Foreign:
Number Of Devices Subject To Recall or Review:
U.S.:
Foreign:
Manufacturer / Recalling Firm, Address:
Product Description (Include Intended Use From Labeling):
ORACLE #
Class:
Recall #(s)
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OIVD: Health Hazard Evaluation Form
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Health Hazard Evaluation or Health Risk Assessment
Center for Devices and Radiological Health
Date:
RES #:
II. Problem Definition and Analysis
Reason for Recall or Risk Assessment
• Description of the Defect, Malfunction or Error in Use of the Device:
• Root Cause of the Problem (If Known):
• Factors That May Contribute to Product Risk (i.e. Device Design,
Manufacturing Problems or User Error):
• Design Factors That Might Mitigate Risk?
• If Device Failure Occurs Is It Easily Recognized by User?
Manufacturer’s CAPA Investigation (If Available):
• Summary:
• Date of Analysis:
• Firm’s Estimate of Number of Devices that will Develop the Defect
and/or Fail :
• How Many Devices from the Affected Lots Are Expected to
Have or Develop the Defect?
• How Many Devices with the Defect are Likely to Exhibit the
Failure Over the Lifetime of the Device?
• Of Those Devices that Fail, How Many are Likely to Cause
Injury if Used?
• Any Comments on How these Estimates were Reached:
• Firm’s Conclusion About Health Risk. (Attach a Copy of Firm’s HHEs or
HHAs):
• Any FDA Comments:
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OIVD: Health Hazard Evaluation Form
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Adverse Events, Complaints and Problems or Incidents that may be
Related to the Device Defect :
Number of Complaints
Injuries Reported
Deaths Reported
Malfunction Reports
U.S.
U.S.
International
International
Sources:
Manufacturer
Inspection
MDR’s
Explanation:
Describe the Complaints and Injuries Reported to Date:
Health Hazard Evaluation or Health Risk Assessment
Center for Devices and Radiological Health
Date:
RES #:
III. Health Risks
TO BE COMPLETED BY MEDICAL OFFICER OR COMMITTEE
THE FOLLOWING ASSESSMENT IS BASED ON CURRENTLY
AVAILABLE INFORMATION. CONCLUSIONS MAY CHANGE IF
ADDITIONAL INFORMATION BECOMES AVAILABLE IN THE FUTURE.
Immediate and Long Range Health Consequences:
A. Describe the Immediate and Long Range Health Consequences
(Injuries or Illnesses) That May Result from Use of or Exposure to the
Defective Device. (Include Known Off Label Uses)
B. Describe Any Clinical Factors That May Mitigate the Risk:
C. What Segment of the Population is Most at Risk? (e.g. Infants, Elderly,
Pregnant Women, Critically Ill Patients, Immunocompromised, etc.)
D. Does the Health Consequence Have Significant Public Health Impact
Beyond Users (e.g. Spread of Serious Infection to Others)?
Assess the hazards associated with use of the defective product
Check All that Might Occur:
Population at
Overall
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OIVD: Health Hazard Evaluation Form
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Greatest Risk
Population
Using Device
Life-threatening (death has or could
occur)
Results in permanent impairment of
body function or permanent damage
to a body structure.
Necessitates medical or surgical
intervention.
Temporary or reversible (without
medical intervention).
Limited (transient, minor impairment
or complaints).
No adverse health consequences.
Hazard cannot be assessed with the
data currently available.
Explanation:
Assess the Probability that Use of, or Exposure to, Product under Recall
will Cause Adverse Health Consequences
Serious Adverse Health
Consequences
Medically Reversible or
Transient Adverse Health
(Death, Life Threatening,
Consequences
Results in Permanent
Impairment)
Overall
Overall
Population
Population
Population
Population
at Greatest
at Greatest
Using
Using
Risk
Risk
Device
Device
Every Time
Reasonable
Probability that
Use will Cause
Remote
Probability that
Use will Cause
Not Likely that
Use will Cause
Any Adverse
Events
Explanation / Comments:
Signatures
Date
Printed Name
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OIVD: Health Hazard Evaluation Form
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Updated February 1, 2007
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