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/biologics-
guidances 
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: CDRH-Guidance@fda.hhs.gov 
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-documents-
regulatory-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 Industry1 
 
Postmarketing Adverse Event Reporting for Medical Products 
and Dietary Supplements During a Pandemic 
 
 
 
This guidance represents the Food and Drug Administrations (FDAs) 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 events3 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 FDAs 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 Agencys recommendations in the 2012 final guidance apply to 
any pandemic, including COVID-195.  Accordingly, this guidance replaces the 2012 final 
guidance.  
 
FDAs 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 industrys 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 firms 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-concerning-
novel-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 firms 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 firms 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 firms 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? 
 
                                                           
6 Available at https://www.cdc.gov/coronavirus/2019-ncov/php/pandemic-preparedness-resources.html. 
 
7 Available at https://asprtracie.hhs.gov/.  
 
8 See Continuity of Operations (COOP) /Business Continuity Planning available at https://asprtracie.hhs.gov/technical-
resources/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 pandemic-
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 firms 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 pandemic- 
related 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 E pidemiology, 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 FDAs 
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  FDA Recommended Reporting During a 
Timeframe(s)1  Pandemic With High Employee 
Absenteeism 
Products with special concerns as specified by FDA  As per regulation(s) and/or statute(s) relating to the  Submit3 
(any product or application type below)2  FDA-specified product 
Prescription drug products marketed without an  15-day Alert report, 15-day Alert report -follow up /  Submit 
approved New Drug Application (NDA): drugs  15 calendar days 
compounded or repackaged by outsourcing 
facilities4 
Prescription drug products marketed without an  15-day Alert report, 15-day Alert report -follow up /  Store if necessary5 
approved New Drug Application (NDA): other  15 calendar days   
drugs 
Approved NDA, Approved Abbreviated New Drug  15-day Alert report, 15-day Alert report -follow up /  Approved NDA, Approved ANDA 
Application (ANDA)  15 calendar days   
1.  use for the pathogen causing the pandemic or    1.  Submit 
the disease caused by the pathogen6  AND   
2.  approved within prior three years    2.  Submit 
Reports to applicant (or licensed manufacturer) instead   
3.  all other products  of FDA /  3.  Submit death outcome reports.  Store if 
    5 calendar days  necessary other serious outcome (non-death) 
reports. 
Approved Biologics License Application (BLA)    Approved BLA 
1.  use for the pathogen causing the pandemic or the  1.  Submit 
disease caused by the pathogen6   
2.  approved within prior three years  2.  Submit 
 
3.  all other biologics  
3.  Submit death outcome reports.  Store if 
necessary other serious outcome (non-death) 
reports. 
 
 
1 Refer to the appendix for Current Requirements for Postmarketing Safety Reports. 
2 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   
Contains Nonbinding Recommendations 
 
 
     
Type of Product or Application  Type of Report(s)/ Statutory or Regulatory  FDA Recommended Reporting During a 
Timeframe(s)  Pandemic With High Employee 
Absenteeism 
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 
Approved ANDA: all products  license) and then annually thereafter 
Approved BLA: all products 
Nonprescription Drugs Marketed without an Approved  Serious adverse event report / 15 business days  Store if necessary 
Application8 
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  Submit 
possible (oral or written) and 7 days (written) 
Source Plasma  Donor fatality report / As soon as possible (oral)  Submit 
Human Cells. Tissue, and Cellular and Tissue-Based  Adverse reaction report / 15 calendar days  Submit 
Products (HCT/P) 
Medical Device  Manufacturer Medical Device Report (MDR) to FDA / 5  Submit 
work days 
  Manufacturer MDR to FDA / 30 calendar days  1. Submit if patient death 
2. Store, if necessary, if nonfatal serious injury or device 
malfunction9 
  MDR from importer to manufacturer and FDA / 30  1. Submit if patient death 
calendar days  2. Store, if necessary, if nonfatal serious injury 
  MDR from user facility to manufacturer (and/or FDA) /  1. Submit if patient death 
10 work days  2. Store, if necessary, if nonfatal serious injury 
 
7 Includes periodic safety update repo  rts (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  Section of  Type of Report(s)/ Timeframe  Type of Information  Persons with Reporting 
Type of Application  21 CFR or  Responsibility 
FD&C Act 
DRUGS AND BIOLOGICS 
Prescription Drug  310.305  15-day Alert report; 15-day Alert report-  Serious and unexpected adverse drug  Manufacturers, packers, distributors 
Products Marketed  followup / 15 calendar days  experience;  New information from follow up of   
without an Approved    15-day Alert report   
NDA       
Reports to manufacturer (or licensed  Serious adverse drug experiences  Packers and distributors 
manufacturer) instead of FDA / 5 
calendar days 
Approved NDA  314.80, 314.98,  15-day Alert report; 15-day Alert report-  Serious and unexpected adverse drug  Applicants ( 314.80, 314.98), licensed 
(prescription and  and 600.80,  followup / 15 calendar days  experience;  New information from follow up of  manufacturers ( 600.80), 
nonprescription  respectively    15-day Alert report  manufacturers, packers, and distributors 
drugs),      ( 314.80, 314.98, and 600.80) and 
Approved ANDA      joint manufacturers, shared 
(prescription and      manufacturers, or any other participant 
nonprescription      involved in divided manufacturing 
drugs), and      ( 600.80) 
Approved BLA  Reports to applicant (or licensed  Serious adverse drug experiences   
(biologics)  manufacturer) instead of FDA / 5    Manufacturers, packers, and distributors 
calendar days    ( 314.80, 314.98,and 600.80) and joint 
    manufacturers, shared manufacturers, or 
    any participant involved in divided 
    manufacturing ( 600.80) 
Periodic adverse drug experience report /   Individual case safety reports for each adverse   
Quarterly for 3 years from the date of  drug experience not submitted to FDA as a 15-  Applicants ( 314.80, 314.98) or 
U.S. approval of the application/issuance  day Alert report, excluding reports from  licensed manufacturers ( 600.80) 
of license and annually thereafter unless  postmarketing studies, reports in the scientific 
otherwise required by FDA  literature, and foreign marketing experience 
 
 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 
   
Contains Nonbinding Recommendations 
 
 
Type of Product or  Section of  Type of Report(s)/ Timeframe  Type of Information  Persons with Reporting 
Type of Application  21 CFR or  Responsibility 
FD&C Act 
 
 
DRUGS AND BIOLOGICS (contd) 
Nonprescription Drugs  FD&C Act  Serious adverse event report, new  Serious adverse events  Manufacturers, packers, or distributors 
Marketed without an  Subchapter H  medical information (followup) report / 
Approved Application  Sec.760  15 business days 
 
DIETARY SUPPLEMENTS 
Dietary Supplements  FD&C Act  Serious adverse event report, new  Serious adverse events  Manufacturers, packers, or distributors 
Subchapter H  medical information (followup) report / 
Sec.761  15 business days 
 
BLOOD AND BLOOD COMPONENTS, INCLUDING SOURCE PLASMA 
Blood and Blood  606.170  Blood collection/transfusion fatality  Fatalities associated with complications of  Blood collecting facility or transfusing 
Components  report / notification as soon as possible  blood collection or transfusion  facility 
(by telephone, fax, e-mail or express 
mail) and written report of investigation 
within 7 days 
Source Plasma  640.73  Donor fatality report / as soon as  Fatalities associated with Source Plasma  Source Plasma establishments 
possible (by telephone)  collection 
10 
   
Contains Nonbinding Recommendations 
 
HUMAN CELLS, TISSUE, AND CELLULAR AND TISSUE-BASED PRODUCTS 
Type of Product or  Section of  Type of Report(s)/ Timeframe  Type of Information  Persons with Reporting 
Type of Application  21 CFR or  Responsibility 
FD&C Act 
Human Cells, Tissue,  1271.350(a)  Adverse reaction report / 15 calendar  Communicable disease associated with HCT/P  Establishments that make the HCT/P 
and Cellular and Tissue-  days  if fatal, life-threatening, results in permanent  available for distribution  
Based Products (HCT/P)  impairment of body function or permanent 
damage to body structure or necessitates 
medical or surgical intervention 
 
MEDICAL DEVICES 
Medical Devices  803.50  Medical device reporting (MDR) to  Device may have caused/contributed to death or  Manufacturers 
FDA / 30 calendar days  serious injury, or device malfunctioned and 
would be likely to cause/contribute to death or 
serious injury if malfunction recurs 
  803.53  MDR to FDA / 5 work days  MDR reportable event necessitates remedial  Manufacturers 
action to prevent unreasonable risk of 
substantial harm to public health, or report 
requested by FDA 
  803.56  Supplemental (followup) reports / within  Followup information received on a previously  Manufacturers 
30 calendar days  submitted 5-day or 30-day MDR 
  803.40  MDR to manufacturer and FDA /  Device may have caused/contributed to death or  Importers 
30 calendar days  serious injury 
  803.40  MDR to manufacturer/ 30 calendar days  Device has malfunctioned and would be likely  Importers 
to cause/contribute to death or serious injury if 
malfunction recurs 
  803.30  MDR to manufacturer and FDA /  Device may have caused/contributed to death  User Facilities 
10 work days 
  803.30  MDR to manufacturer (or FDA if  Device may have caused/contributed to serious  User Facilities 
manufacturer not known) / 10 work days  injury 
  803.33  Annual Report / yearly by January 1  Summary of previously submitted reports (not  User Facilities 
required if no reports) 
 
11