Add Adverse Event Reporting Plan to COOP

Guidance for Industry
Postmarketing Adverse Event Reporting
for Medical Products and Dietary
Supplements During an Influenza
Pandemic

U.S. Department of Health and Human Services
Food and Drug Administration
Office of Counterterrorism and Emerging Threats (OCET)
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)
Center for Food Safety and Applied Nutrition (CFSAN)
February 2012
Safety

OMB Control Number 0910-0701
Expiration Date: 04/30/2018 (Note: Expiration date updated 04/10/2018)
See additional PRA statement in Section IV of this guidance

Guidance for Industry
Postmarketing Adverse Event Reporting
for Medical Products and Dietary
Supplements During an Influenza
Pandemic
Additional copies are available from:
Office of Counterterrorism and Emerging Threats (HF-29)
Office of the Commissioner
(Tel) 301-796-8510
and/or
Office of Communication, Division of Drug Information
Center for Drug Evaluation and Research
(Tel) 301-796-3400; (Fax) 301-847-8714
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

and/or
Office of Communication, Outreach and Development (HFM-40)
Center for Biologics Evaluation and Research
(Tel) 800-835-4709 or 301-827-1800
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

and/or
Office of Communication, Education and Radiation Programs
Division of Small Manufacturers, International and Consumer Assistance
Center for Devices and Radiological Health
(Tel) Manufacturers Assistance: 800.638.2041 or 301.796.7100, Fax: 301.827.8149
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
and/or

Office of Food Defense, Communication and Emergency Response (HFS-005)
Center for Food Safety and Applied Nutrition
(Tel) 240-276-9300
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/default.htm

U.S. Department of Health and Human Services
Food and Drug Administration
Office of Counterterrorism and Emerging Threats (OCET)
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)
Center for Food Safety and Applied Nutrition (CFSAN)
February 2012
Safety

Contains Nonbinding Recommendations

TABLE OF CONTENTS

I.

INTRODUCTION............................................................................................................. 1

II.

BACKGROUND ............................................................................................................... 2

III.

PREPAREDNESS FOR ADVERSE EVENT REPORTING DURING AN
INFLUENZA PANDEMIC .............................................................................................. 2

A.

Information on Pandemic Influenza Preparedness .................................................................... 2

B.

Development of a Continuity of Operations Plan in the Case of an Influenza Pandemic ....... 2

C.

FDA Expectations for Adverse Event Reporting During an Influenza Pandemic ................... 3

1. Reporting Requirements During an Influenza Pandemic ................................................................ 3
2. Enforcement Approach During an Influenza Pandemic with High Employee Absenteeism............ 4
D. Reporting After the Influenza Pandemic ..................................................................................... 5

IV.

PAPERWORK REDUCTION ACT OF 1995 ................................................................ 5

Table 1. FDA Approach to Postmarketing Safety Reporting During an Influenza Pandemic if
Normal Processes of Mandatory Adverse Event Reporting Are Not Feasible Because of High
Employee Absenteeism ............................................................................................................................... 7

APPENDIX 1: CURRENT REQUIREMENTS FOR POSTMARKETING SAFETY
REPORTS .................................................................................................................................... 10

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Contains Nonbinding Recommendations

Guidance for Industry1
Postmarketing Adverse Event Reporting for Medical Products and
Dietary Supplements During an Influenza Pandemic

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It
does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes
and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for
implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate
number listed on the title page of this guidance.

I.

INTRODUCTION

This guidance provides recommendations to industry regarding postmarketing adverse event
reporting for drugs, biologics, medical devices, and dietary supplements during an influenza
pandemic. FDA anticipates that during an influenza pandemic, industry and FDA workforces
may be reduced because of high employee absenteeism while reporting of adverse events2
related to widespread use of medical products indicated for the treatment or prevention of
influenza may increase. The extent of these possible changes is unknown. This guidance
discusses FDA’s intended approach to enforcement of adverse event reporting requirements for
medical products and dietary supplements during an influenza pandemic. FDA believes this
approach will make it possible for firms with reporting responsibilities to focus their limited
resources on the following types of reports:
 reports related to medical products indicated for the treatment or prevention of
influenza
 other reports indicated in this guidance
 reports on products presenting special concerns as specified by FDA

1

This guidance has been prepared by the Office of Surveillance and Epidemiology in the Center for Drug
Evaluation and Research (CDER) in cooperation with the Office of Counterterrorism and Emerging Threats (OCET)
in the Office of the Commissioner and the Centers for Biologics Evaluation and Research (CBER), Devices and
Radiological Health (CDRH), and Food Safety and Applied Nutrition (CFSAN) at the Food and Drug
Administration.
2

For purposes of this guidance, the term adverse event includes adverse experience and adverse reaction.
Appendix 1 lists in abbreviated form the current adverse event reporting requirements for drugs, biologics, medical
devices, and dietary supplements. Refer to the relevant statutes, regulations, and guidance documents for complete
information.

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Contains Nonbinding Recommendations
This guidance is not intended to discourage adverse event reporting during an influenza
pandemic by firms that are able to continue reporting operations. In addition, this guidance does
not address monitoring and reporting of adverse events that might be imposed as a condition for
medical products authorized for emergency use under section 564 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3).3 This guidance also does not address
monitoring and reporting of adverse events as required by regulations establishing the conditions
for investigational use of drugs, biologics, and devices. (See 21 CFR parts 312 and 812.)
FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should
be viewed only as recommendations, unless specific regulatory or statutory requirements are
cited. The use of the word should in Agency guidances means that something is suggested or
recommended, but not required.

II.

BACKGROUND

Pandemic preparedness is a global responsibility. It is expected that widespread human
outbreaks of pandemic influenza, whether overseas or in the United States, will affect industry’s
normal functions. Although overseas outbreaks may not seem to directly affect domestic
operations, international medical product and dietary supplement production, availability, and
adverse event reporting may be disrupted if a firm’s international sites are affected. Thus,
industry should develop plans to ensure continuity of operations during an influenza pandemic
(discussed in section III.B). It is important that firms consider the adverse event reporting
functions of their U.S. locations and their international locations in the face of a potential
pandemic.

III.

PREPAREDNESS FOR ADVERSE EVENT REPORTING DURING AN
INFLUENZA PANDEMIC
A.

Information on Pandemic Influenza Preparedness

The Department of Health and Human Services (HHS) manages the U.S. Government flu
information Web site (www.pandemicflu.gov), which provides a variety of information about
influenza, including general information on pandemic influenza preparedness planning.
Manufacturers should refer to the Web site frequently for updated information on influenza.
B.

Development of a Continuity of Operations Plan in the Case of an Influenza
Pandemic

To access general information on pandemic influenza preparedness planning, firms should refer
to the pandemicflu.gov Web site.4 This site recommends that each firm should develop a
3

For information regarding Emergency Use Authorizations (EUAs), please refer to the guidance on Emergency Use
Authorization of Medical Products (July 2007), available on the Internet at
http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm.
4

Available at http://www.pandemicflu.gov under “For Professionals, Business Planning.”
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Contains Nonbinding Recommendations
continuity of operations plan (COOP) to ensure that its operations continue during all stages of
pandemic influenza. Guidance on developing COOP plans is available from various sources.
For example, the U.S. Department of Homeland Security (DHS) has issued a Pandemic Influenza
Preparedness, Response, and Recovery Guide for Critical Infrastructure and Key Resources,
which addresses the development and implementation of a “Continuity of Operations – Essential
(COP-E)” plan.5
This guidance is limited to FDA recommendations for reporting adverse events during a period
of pandemic influenza. Each firm’s pandemic influenza COOP plan should include instructions
for reporting adverse events and provide a plan for the submission of any stored reports not
submitted in the regulatory timeframes.
C.

FDA Expectations for Adverse Event Reporting During an Influenza
Pandemic

1.

Reporting Requirements During an Influenza Pandemic

During an influenza pandemic, normal adverse event reporting processes should be maintained
to the maximum extent possible. All adverse event data should be handled using each firm’s
usual standard operating procedures, and regulatory and statutory requirements for adverse event
reporting should be met to the maximum extent possible.
Firms should develop and prepare to implement their COOP in the event that they are not able to
fulfill all adverse event reporting requirements because of pandemic-related high employee
absenteeism. FDA recommends that in planning, firms consider the following types of factors
(not all-inclusive):
 What activities are directly relevant to the processing and submission of mandatory
adverse event reports to FDA?
 How would sites based in the United States and abroad be differentially affected by a
pandemic?
 What are the relative amounts of resources dedicated to mandatory adverse event
reporting at each site?
Firms that are unable to fulfill normal adverse event reporting requirements during an influenza
pandemic should maintain documentation of both of the following conditions:

Available at http://www.pandemicflu.gov under “For Professionals, Federal Government, Other Federal Agency
Activities.”
5

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Contains Nonbinding Recommendations
1. Declaration of an influenza pandemic (e.g., by federal government), including date of
declaration of the pandemic and ending date of the pandemic, and
2. High absenteeism and/or other factors (e.g., an increase in adverse event reporting) that
is/are preventing the firm from meeting normal adverse event reporting requirements
The appropriate FDA organizational units responsible for adverse event reporting compliance
should be notified when these conditions exist.
2.

Enforcement Approach During an Influenza Pandemic with High Employee
Absenteeism

FDA anticipates that during an influenza pandemic, industry and FDA workforces may be
reduced because of high employee absenteeism at the same time that reporting of adverse events
related to influenza-related medical products may increase.
FDA encourages all firms to plan for these circumstances to maintain the highest feasible level
of adverse event monitoring and reporting throughout the pandemic period when a firm is
experiencing pandemic-related high employee absenteeism. Recognizing that a pandemic may
reduce a firm’s capacity to comply with adverse event reporting requirements, however, FDA
offers this general guidance to help manufacturers strategize use of their resources.
As explained below, FDA does not intend to object if, because of pandemic-related high
employee absenteeism, certain required adverse event reports are not submitted to the FDA
within the timeframes required by statute and regulation, provided that any delayed reports are
submitted within 6 months of the restoration of adverse event reporting processes to their prepandemic state (see section III.D for discussion of prioritizing timeframes for submission of
stored reports).
Table 1 indicates which reports firms may generally store if necessary because of pandemicrelated high employee absenteeism, without FDA objection. Where Table 1 indicates a type of
report may be stored if necessary, this means that FDA does not intend to object if firms
maintain newly received information regarding the underlying adverse events and do not submit
reports in the timeframes mandated by statute or regulation. However, any delayed reports must
be submitted after adverse event reporting processes have been restored to the pre-pandemic
state. Firms should maintain records to identify what has been stored and when the processes
were restored.
This guidance does not apply to adverse event reporting during an influenza pandemic by firms
that are able to continue reporting operations. Firms that are able to report more than the
minimum described in Table 1 but less than that required by the statute and applicable
regulations should prioritize the order of report submissions. For example, reports with
regulatory timeframes of 30 days or less (e.g., 15-day reports, 30-day reports) should be
submitted before periodic safety reports. During an influenza pandemic, all firms are strongly
encouraged to submit as many required reports as possible. This will minimize reporting
burdens once adverse event reporting processes have been restored to the pre-pandemic state.
FDA intends to communicate with firms if there are products and issues that present special
concerns and for which the agency therefore expects compliance with normal reporting as
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Contains Nonbinding Recommendations
required by statute and regulation during the influenza pandemic. Special concerns could
include:
 product-related safety issues such as (but not limited to) newly emerging safety issues
(e.g., an antihypertensive drug associated with liver failure or a non-influenza vaccine
associated with anaphylaxis)
 product problems with associated adverse events (e.g., nonfatal serious infections
associated with a pre-filled syringe that was recalled due to bacterial contamination)
As indicated in Table 1, if FDA has specified a product as presenting special concerns, firms
must submit required adverse event reports regardless of the more general recommendations in
Table 1. Aside from this circumstance, in Table 1, reporting recommendations for drugs and
biologics are prioritized by type of product so that reporting can focus on products that are likely
to have greater use and may necessitate greater monitoring during an influenza pandemic.
Further, 15-day reports have priority over periodic reports. For medical devices, the reporting
priority is specified by outcome (i.e., fatal outcome vs. nonfatal outcome). Table 1 also includes
reporting recommendations for other products and additional details.
D.

Reporting After the Influenza Pandemic

After the influenza pandemic, it is expected that firms will resume fulfilling all reporting
requirements on time as well as submit reports that were stored because of pandemic-related high
employee absenteeism. Firms should follow their plan for the submission of the stored reports
not submitted in the regulatory timeframes. Firms are generally expected to submit stored reports
to FDA within 6 months of restoration of the adverse event reporting process to the prepandemic state. Firms should prioritize the order of submission for stored reports. For example,
reports with regulatory timeframes of 30 days or less (e.g., 15-day reports, 30-day reports)
should be submitted before periodic safety reports.
Firms that cannot meet adverse event reporting requirements at the minimum levels identified in
this guidance should consult the appropriate FDA organizational unit responsible for adverse
event reporting compliance.
IV.

PAPERWORK REDUCTION ACT OF 1995

This guidance contains information collection provisions that are subject to review by the Office
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3520).
The time required to complete this information collection is estimated to average 50 hours per
response to prepare an adverse reporting plan for a COOP and 8 hours per response to notify
FDA when normal reporting is not feasible, to maintain documentation of influenza pandemic
conditions and resultant high absenteeism, and to maintain records to indentify what reports have
been stored and when the reporting process was restored, including the time to review
instructions, search existing data sources, gather the data needed, and complete and review the
information collection. Send comments regarding this burden estimate or suggestions for
reducing this burden to:

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Contains Nonbinding Recommendations
Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4480, Silver Spring, MD
20993-0002.
This guidance also refers to previously approved collections of information found in FDA’s
adverse event reporting requirements in 21 CFR 310.305, 314.80, 314.98, 600.80, 606.170,
640.73, 1271.350, and part 803. These regulations contain collections of information that are
subject to review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520) and are approved under OMB control numbers
0910-0116, 0910-0291, 0910-0230, 0910-0308, 0910-0437, and 0910-0543. In addition, the
guidance also refers to adverse event reports for nonprescription human drug products marketed
without an approved application and dietary supplements required under sections 760 and 761 of
the Act (21 U.S.C. 379aa and 379aa-1), which include collections of information approved under
OMB control numbers 0910-0636 and 0910-0635.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number. The OMB control number
for this information collection is 0910-0701 (expires 04/30/2018 (Note: Expiration date updated
04/10/2018).

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Contains Nonbinding Recommendations
Table 1. FDA Approach to Postmarketing Safety Reporting During an Influenza Pandemic if Normal Processes of
Mandatory Adverse Event Reporting Are Not Feasible Because of High Employee Absenteeism
Type of Product or Application

Type of Report(s)/Statutory or Regulatory
Timeframe(s)1

FDA Recommended Reporting During an
Influenza Pandemic With High Employee
Absenteeism

Products with special concerns as specified by FDA
(any product or application type below)2

As per regulation(s) and/or statute(s) relating to the
FDA-specified product

Submit3

Prescription drug products marketed without an
approved NDA

15-day Alert report, 15-day Alert report -follow up /
15 calendar days

Store if necessary4

Approved NDA, Approved ANDA
1. labeled indication for influenza
2. approved within prior three years
3. all other products

15-day Alert report, 15-day Alert report -follow up /
15 calendar days

Approved NDA, Approved ANDA
1. Submit
2. Submit
3. Store if necessary

Approved BLA
1. Pandemic influenza vaccines
2. Biologics (vaccines or nonvaccines) approved
within prior three years
3. Other biologics (vaccines or nonvaccines)
Approved NDA: all products
Approved ANDA: all products

AND
Reports to applicant (or licensed manufacturer) instead
of FDA /
5 calendar days

Periodic adverse drug experience report5/ Quarterly for
3 years from the date of U.S. approval of the application
(or license) and then annually thereafter

Approved BLA
1. Submit
2. Submit
3. Submit death outcome reports. Store if
necessary other serious outcome (non-death)
reports.
Store if necessary

Approved BLA: all products

1

Refer to Appendix 1 for Current Requirements for Postmarketing Safety Reports.
FDA will specifically communicate with firms regarding which products present special concerns. Refer to section III.C.2 of this guidance for further
discussion of special concern products.
3
As used in this document, “submit” means that the Agency continues to expect compliance with the specific regulatory requirements for submission, including
applicable timeframes.
4
Refer to section III.C.2 of this guidance.
5
Includes periodic safety update reports (PSURs) if applicant has a waiver allowing submission of PSURs in lieu of periodic adverse (drug) experience reports.
2

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Contains Nonbinding Recommendations

8

Contains Nonbinding Recommendations

Type of Product or Application

Type of Report(s)/ Statutory or Regulatory
Timeframe(s)

FDA Recommended Reporting During an
Influenza Pandemic With High Employee
Absenteeism

Nonprescription Drugs Marketed without an Approved
Application6

Serious adverse event report / 15 business days

Store if necessary

Dietary Supplement Products

Serious adverse event report / 15 business days

Store if necessary

Blood and Blood Components

Blood collection/transfusion fatality report / As soon as
possible (oral or written) and 7 days (written)

Submit

Source Plasma

Donor fatality report / As soon as possible (oral)

Submit

Human Cells. Tissue, and Cellular and Tissue-Based
Products (HCT/P)

Adverse reaction report / 15 calendar days

Submit

Medical Device

Manufacturer Medical Device Report (MDR) to FDA / 5
work days

Submit

Manufacturer MDR to FDA / 30 calendar days

MDR from importer to manufacturer and FDA / 30
calendar days

1. Submit if patient death
2. Store, if necessary, if nonfatal serious injury or device
malfunction
1. Submit if patient death
2. Store, if necessary, if nonfatal serious injury

MDR from user facility to manufacturer (and/or FDA) /
10 work days

1. Submit if patient death
2. Store, if necessary, if nonfatal serious injury

6

For purposes of section 760 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), nonprescription drug means a drug that is (1) not subject to section
503(b) of the FD&C Act and (2) not subject to approval in an application submitted under section 505 of the FD&C Act. See section 760(a)(2) of the FD&CAct
(21 U.S.C. 379aa(a)(2)).

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Contains Nonbinding Recommendations
APPENDIX 1: CURRENT REQUIREMENTS FOR POSTMARKETING SAFETY REPORTS
Type of Product or
Type of Application

Section of
21 CFR or
FD&C Act

Type of Report(s)/ Timeframe

Type of Information

Persons with Reporting
Responsibility

DRUGS AND BIOLOGICS
Prescription Drug
Products Marketed
without an Approved
NDA

Approved NDA
(prescription and
nonprescription
drugs),
Approved ANDA
(prescription and
nonprescription
drugs), and
Approved BLA
(biologics)

310.305

314.80, 314.98,
and 600.80,
respectively

15-day Alert report; 15-day Alert reportfollowup / 15 calendar days

Serious and unexpected adverse drug
experience; New information from follow up of
15-day Alert report

Manufacturers, packers, distributors

Reports to manufacturer (or licensed
manufacturer) instead of FDA / 5
calendar days

Serious adverse drug experiences

Packers and distributors

15-day Alert report; 15-day Alert reportfollowup / 15 calendar days

Serious and unexpected adverse drug
experience; New information from follow up of
15-day Alert report

Applicants (§§ 314.80, 314.98), licensed
manufacturers (§ 600.80),
manufacturers, packers, and distributors
(§§ 314.80, 314.98, and 600.80) and
joint manufacturers, shared
manufacturers, or any other participant
involved in divided manufacturing
(§ 600.80)

Reports to applicant (or licensed
manufacturer) instead of FDA / 5
calendar days

Serious adverse drug experiences

Periodic adverse drug experience report /
Quarterly for 3 years from the date of
U.S. approval of the application/issuance
of license and annually thereafter unless
otherwise required by FDA

• Individual case safety reports for each adverse
drug experience not submitted to FDA as a 15day Alert report, excluding reports from
postmarketing studies, reports in the scientific
literature, and foreign marketing experience

Manufacturers, packers, and distributors
(§§ 314.80, 314.98,and 600.80) and joint
manufacturers, shared manufacturers, or
any participant involved in divided
manufacturing (§ 600.80)

• Summary portion: includes narrative summary
and analysis of adverse drug experiences that
occurred during the reporting interval including
15-day Alert reports previously submitted to
FDA, an index of individual case safety reports
included in the report, and history of actions
taken since the last Periodic report.

10

Applicants (§§ 314.80, 314.98) or
licensed manufacturers (§ 600.80)

Contains Nonbinding Recommendations
Type of Product or
Type of Application

Section of
21 CFR or
FD&C Act

Type of Report(s)/ Timeframe

Type of Information

Persons with Reporting
Responsibility

DRUGS AND BIOLOGICS (cont’d)
Nonprescription Drugs
Marketed without an
Approved Application

FD&C Act
Subchapter H
Sec.760

Serious adverse event report, new
medical information (followup) report /
15 business days

Serious adverse events

Manufacturers, packers, or distributors

DIETARY SUPPLEMENTS
Dietary Supplements

FD&C Act
Subchapter H
Sec.761

Serious adverse event report, new
medical information (followup) report /
15 business days

Serious adverse events

Manufacturers, packers, or distributors

BLOOD AND BLOOD COMPONENTS, INCLUDING SOURCE PLASMA
Blood and Blood
Components

606.170

Blood collection/transfusion fatality
report / notification as soon as possible
(by telephone, fax, e-mail or express
mail) and written report of investigation
within 7 days

Fatalities associated with complications of
blood collection or transfusion

Blood collecting facility or transfusing
facility

Source Plasma

640.73

Donor fatality report / as soon as
possible (by telephone)

Fatalities associated with Source Plasma
collection

Source Plasma establishments

HUMAN CELLS, TISSUE, AND CELLULAR AND TISSUE-BASED PRODUCTS

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Contains Nonbinding Recommendations
Type of Product or
Type of Application
Human Cells, Tissue,
and Cellular and TissueBased Products (HCT/P)

Section of
21 CFR or
FD&C Act
1271.350

Type of Report(s)/ Timeframe

Type of Information

Adverse reaction report / 15 calendar
days

Communicable disease associated with HCT/P
if fatal, life-threatening, results in permanent
impairment of body function or permanent
damage to body structure or necessitates
medical or surgical intervention

Persons with Reporting
Responsibility
Establishments that manufacture HCT/P

MEDICAL DEVICES
Medical Devices

803.50

Medical device report (MDR) to FDA /
30 calendar days

Manufacturers

Supplemental (followup) reports / within
one month

Device may have caused/contributed to death or
serious injury, or device malfunctioned and
would be likely to cause/contribute to death or
serious injury if malfunction recurs
MDR reportable event necessitates remedial
action to prevent unreasonable risk of
substantial harm to public health, or report
requested by FDA
Followup information received on a previously
submitted 5-day or 30-day MDR

803.53

MDR to FDA / 5 work days

803.56
803.40

MDR to manufacturer and FDA /
30 calendar days

Device may have caused/contributed to death or
serious injury

Importers

803.40

MDR to manufacturer/ 30 calendar days

Importers

803.30

MDR to manufacturer and FDA /
10 work days

Device has malfunctioned and would be likely
to cause/contribute to death or serious injury if
malfunction recurs
Device may have caused/contributed to death

803.30

MDR to manufacturer (or FDA if
manufacturer not known) / 10 work days

Device may have caused/contributed to serious
injury

User Facilities

803.33

Annual Report / yearly by January 1

Summary of previously submitted reports (not
required if no reports)

User Facilities

12

Manufacturers

Manufacturers

User Facilities