AER under FFDCA sec. 760 - nonprescription drug products

Guidance for Industry
Postmarketing Adverse Event Reporting
for Medical Products and Dietary
Supplements During a 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)
May 2020
Safety

OMB Control No. 0910-0701
Expiration Date 05/31/2021
See additional PRA statement in section IV of this guidance.

Guidance for Industry
Postmarketing Adverse Event Reporting
for Medical Products and Dietary
Supplements During a 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
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologicsguidances

and/or
Office of Policy
Guidance and Policy Development
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 66, Room 5431
Silver Spring, MD 20993-0002
Email: [email protected]
https://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
https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/guidance-documentsregulatory-information-topic-food-and-dietary-supplements

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)
May 2020
Safety

Contains Nonbinding Recommendations

TABLE OF CONTENTS

I.

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

II.

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

III.

PREPAREDNESS FOR ADVERSE EVENT REPORTING DURING A PANDEMIC ........... 3

A.

Information on Pandemic Preparedness ........................................................................................ 3

B.

Development of a Continuity of Operations Plan in the Case of a Pandemic ............................ 3

C.

FDA Expectations for Adverse Event Reporting During a Pandemic........................................ 3

D.

Reporting After the Pandemic ........................................................................................................ 5

IV.

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

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

CURRENT REQUIREMENTS FOR POSTMARKETING SAFETY REPORTS ....... 9

Contains Nonbinding Recommendations

Guidance for Industry 1
Postmarketing Adverse Event Reporting for Medical Products
and Dietary Supplements During a 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, combination products, 2 and dietary
supplements during a pandemic. FDA anticipates that during a pandemic, industry and FDA
workforces may be reduced because of high employee absenteeism while reporting of
adverse events 3 related to widespread use of medical products indicated for the treatment or
prevention of the pathogen causing the pandemic 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 a
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 the pathogen causing the pandemic

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 requirements related to combination products refer to 21 CFR part 4 (see 78 FR 4307). These are described in the
guidance Postmarketing Safety Reporting for Combination Products, accessible at
https://www.fda.gov/media/111788/download. In addition to application type-based reporting requirements (see 21 CFR
4.102(b)), Combination Product Applicants are also subject to certain safety reporting requirements associated with the
constituent parts of the combination product (see 21 CFR 4.102(c)). FDA recommended reporting during a pandemic
with high employee absenteeism for application-type based reporting requirements and those associated with the
constituent parts of a combination product are as described in Table 1.
3

For purposes of this guidance, the term adverse event includes adverse experience and adverse reaction. The appendix
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.

1

Contains Nonbinding Recommendations
•

other reports indicated in this guidance

•

reports on products presenting special concerns as specified by FDA

This guidance is not intended to discourage adverse event reporting during a 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). 4 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 is revising the final guidance for industry entitled “Postmarketing Adverse Event Reporting
for Medical Products and Dietary Supplements During an Influenza Pandemic" (2012 final
guidance) to clarify that the guidance is applicable to any pandemic, not just an influenza
pandemic. This action is necessary to address the Coronavirus Disease 2019 (COVID-19)
pandemic and to ensure that the Agency’s recommendations in the 2012 final guidance apply to
any pandemic, including COVID-19 5. Accordingly, this guidance replaces the 2012 final
guidance.
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

FDA plays a critical role in protecting the United States from threats such as emerging infectious
diseases, including the COVID-19 pandemic. FDA is committed to providing timely guidance to
support response efforts to this pandemic.
Pandemic preparedness is a global responsibility. It is expected that widespread human outbreaks
of a pandemic, whether overseas or in the United States, will affect industry’s 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 a 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.
4

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.
5

The Secretary of Health and Human Services Alex M. Azar issued a “Determination that a Public Health Emergency
Exists. (Jan. 31, 2020, renewed April 21, 2020), which is available at
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx. The President also issued a Proclamation on
Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020),
available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerningnovel-coronavirus-disease-covid-19-outbreak/.
2

Contains Nonbinding Recommendations
III.

PREPAREDNESS FOR ADVERSE EVENT REPORTING DURING A
PANDEMIC
A.

Information on Pandemic Preparedness

The Department of Health and Human Services (HHS) provides a variety of information about
pandemics, including general information on pandemic preparedness planning, e.g. Pandemic
Preparedness Resources. 6 Manufacturers should refer to this web page frequently for updated
information on pandemics.
B.

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

To access general information on pandemic preparedness planning, firms should refer to the
HealthCare Emergency Preparedness Information Gateway website. 7 This site includes resources
for developing a continuity of operations plan (COOP) to ensure that a firm’s operations continue
during all stages of a pandemic. 8
This guidance is limited to FDA recommendations for reporting adverse events during a period of
pandemic. Each firm’s pandemic 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 a Pandemic

1.

Reporting Requirements During a Pandemic

During a pandemic, adverse event reporting processes as required by statute and regulation 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):

6
7

•

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?

Available at https://www.cdc.gov/coronavirus/2019-ncov/php/pandemic-preparedness-resources.html.
Available at https://asprtracie.hhs.gov/.

8

See Continuity of Operations (COOP) /Business Continuity Planning available at https://asprtracie.hhs.gov/technicalresources/17/continuity-of-operations-coop-business-continuity-planning/110.
3

Contains Nonbinding Recommendations
•

What are the relative amounts of resources dedicated to mandatory adverse event
reporting at each site?

Firms that are unable to fulfill adverse event reporting requirements during a pandemic should
maintain documentation of both of the following conditions:
1. Declaration of a pandemic (e.g., by the World Health Organization), 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 adverse event reporting requirements
The appropriate FDA organizational units responsible for adverse event reporting compliance
should be notified when these conditions exist as soon as practicable, recognizing that notifications
may be delayed due to the need to address more urgent safety issues.
2.

Enforcement Approach During a Pandemic with High Employee Absenteeism

FDA anticipates that during a pandemic, industry and FDA workforces may be reduced because of
high employee absenteeism at the same time that reporting of adverse events related to pandemicrelated 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 pre-pandemic 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 a 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 a
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.
4

Contains Nonbinding Recommendations
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 reporting as required by
statute and regulation during the 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-pandemic-related
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 a 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 Pandemic

After the pandemic is resolved and a pre-pandemic state has been restored, 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 pre-pandemic state, or after notification by the Agency, any time frame
established by FDA. 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 event reporting plan for a COOP and 8 hours per response to notify
FDA when reporting as required by statute and regulation is not feasible, to maintain documentation
of the pandemic conditions and resultant high absenteeism, and to maintain records to identify 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:
5

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 05/31/2021).

6

Contains Nonbinding Recommendations
Table 1. FDA Approach to Postmarketing Safety Reporting During a Pandemic if 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 a
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 New Drug Application (NDA): drugs
compounded or repackaged by outsourcing
facilities4
Prescription drug products marketed without an
approved New Drug Application (NDA): other
drugs

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

Submit

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

Store if necessary5

Approved NDA, Approved Abbreviated New Drug
Application (ANDA)
1. use for the pathogen causing the pandemic or
the disease caused by the pathogen6
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

Approved Biologics License Application (BLA)
1. use for the pathogen causing the pandemic or the
disease caused by the pathogen6
2. approved within prior three years
3. all other biologics

1

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

1.

Submit

2.

Submit

3.

Submit death outcome reports. Store if
necessary other serious outcome (non-death)
reports.

Approved BLA
1. Submit
2.

Submit

3.

Submit death outcome reports. Store if
necessary other serious outcome (non-death)
reports.

Refer to the appendix 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
Reporting is to be continued because of the potential for increased production of compounded drugs during a pandemic, including the COVID-19 pandemic, by
this relatively new industry.
5
Refer to section III.C.2 of this guidance.
6
Whether or not the use is included in the labeling for the drug.
7
2

Contains Nonbinding Recommendations

Type of Product or Application

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

Approved NDA: all products

Periodic adverse drug experience report7/ Quarterly for 3 Store if necessary
years from the date of U.S. approval of the application (or
license) and then annually thereafter

Approved ANDA: all products

FDA Recommended Reporting During a
Pandemic With High Employee
Absenteeism

Approved BLA: all products
Nonprescription Drugs Marketed without an Approved
Application8

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
malfunction9
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

7

Includes periodic safety update reports (PSURs) and periodic benefit-risk evaluation reports (PBRERs) if applicant has a waiver allowing submission of PSURs or
PBRERs in lieu of periodic adverse (drug) experience reports.

8

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&C Act
(21 U.S.C. 379aa(a)(2)).
9

The recommendations are also applicable to events reported under the Voluntary Malfunction Summary Reporting (VMSR) Program. See 83 FR 40973 for
more details regarding VMSR Program conditions of participation.

8

Contains Nonbinding Recommendations
APPENDIX: 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.

9

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

10

Contains Nonbinding Recommendations
HUMAN CELLS, TISSUE, AND CELLULAR AND TISSUE-BASED PRODUCTS
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(a)

Type of Report(s)/ Timeframe

Adverse reaction report / 15 calendar
days

Type of Information

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 make the HCT/P
available for distribution

MEDICAL DEVICES
Medical Devices

803.50

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

Manufacturers

Supplemental (followup) reports / within
30 calendar days

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

11

Manufacturers

Manufacturers

User Facilities