Contains Nonbinding Recommendations 
Draft - Not for Implementation 
 
 
Draft Guidance for Industry, Food 
and Drug Administration Staff, 
and Clinical Laboratories 
 
 
FDA Notification and Medical 
Device Reporting for Laboratory 
Developed Tests (LDTs) 
 
DRAFT GUIDANCE 
 
This guidance document is being distributed for comment purposes only.  
Document issued on: October 3, 2014 
 
You should submit comments and suggestions regarding this draft document within 120 days 
of publication in the Federal Register of the notice announcing the availability of the draft 
guidance.  Submit written comments to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.  Submit 
electronic comments to http://www.regulations.gov.  Identify all comments with the docket 
number listed in the notice of availability that publishes in the Federal Register. 
 
For questions regarding this document, contact LDTframework@fda.hhs.gov. For questions 
regarding this document as applied to devices regulated by CBER, contact the Office of 
Communication, Outreach and Development in CBER at 1-800-835-4709 or 301-827-1800 or 
ocod@fda.hhs.gov. 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Office of In Vitro Diagnostics and Radiological Health 
 
 
Center for Biologics Evaluation and Research  Contains Nonbinding Recommendations 
Draft - Not for Implementation 
 
Preface 
 
Additional Copies 
 
Additional copies are available from the Internet.  You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance.  Please use the document 
number 1738 to identify the guidance you are requesting. 
 
Or, contact: 
 
Office of Communication, Outreach and Development 
Center for Biologics Evaluation and Research 
Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 71, rm. 3128, Silver Spring, MD 20993-0002 
Internet:  
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/de
fault.htm 
Tel: 800-835-4709 or 240-402-7800 
E-mail:  ocod@fda.hhs.gov 
  Contains Nonbinding Recommendations 
Draft - Not for Implementation 
 
Table of Contents 
 
A.  Introduction ......................................................................................................................... 4 
B.  Background ......................................................................................................................... 5 
C. Scope .................................................................................................................................... 6 
D. Notification to FDA of all LDTs Manufactured by a Laboratory ........................................ 6 
E. Medical Device Reporting for LDTs .................................................................................... 9 
APPENDIX A:  FDA Notification Data Elements ................................................................. 23 
APPENDIX B: ADVERSE EVENT REPORTING REQUIREMENTS ............................... 27  Contains Nonbinding Recommendations 
Draft - Not for Implementation 
 
 
Draft Guidance for Industry,  
Food and Drug Administration Staff, and 
Clinical Laboratories 
 
  
 
FDA Notification and Medical Device 
Reporting for Laboratory Developed 
Tests (LDTs) 
 
This draft guidance, when finalized, will represent 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.  
A.  Introduction  
 
This document is intended to describe the process for clinical laboratories to notify the 
FDA of the laboratory developed tests (LDTs) they manufacture as well as to describe the 
Medical Device Reporting (MDR) requirements, codified in 21 CFR Part 803, for clinical 
laboratories manufacturing LDTs.  LDTs are those in vitro diagnostic devices (IVD) that 
are intended for clinical use and are designed, manufactured and used within a single 
laboratory.1, 2   
 
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 
                                                           
1 Single laboratory refers to a facility with a single CLIA certificate as described in 42 CFR 493.43(a)-(b).  
(See also 42 CFR 493.55).  LDTs should only be designed, manufactured, and used by laboratories that 
meet the requirements for high-complexity testing under CLIA as described in 42 CFR 493.17(c)(4) and 
493.25. 
2 The scope of this guidance is consistent with the scope of the Draft Guidance for Industry, Food and Drug 
Administration Staff, and Clinical Laboratories; Framework for Regulatory Oversight of Laboratory 
Developed Tests (LDTs). 
  4  Contains Nonbinding Recommendations 
Draft - Not for Implementation 
 
 
requirements are cited.  The use of the word should in Agency guidances means that 
something is suggested or recommended, but not required.  
 
B.  Background 
 
LDT Background and Regulatory History 
In 1976, Congress enacted the Medical Device Amendments (MDA), which amended the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) to create a comprehensive 
system for the regulation of medical devices intended for use in humans.  At that time, 
the definition of a device was amended to make explicit that it encompasses in vitro 
diagnostic devices (IVDs).3  The definition of device applies equally to in vitro 
diagnostics manufactured by conventional device manufacturers and those manufactured 
by laboratories.  An IVD, therefore, meets the device definition irrespective of where and 
by whom it is manufactured. 
 
However, since the implementation of the MDA of 1976, FDA has generally exercised 
enforcement discretion so that the Agency has generally not enforced applicable 
provisions under the FD&C Act and FDA regulations with respect to LDTs.  
 
Since 1976, when Congress clarified that IVDs were medical devices under the FD&C 
Act and FDA opted to exercise enforcement discretion with respect to LDTs under this 
authority, the industry has grown and evolved in significant ways.  FDA now finds that in 
the absence of appropriate oversight of LDTs, there is the potential for increased risk for 
patients.   FDA recognizes that, as with all IVDs, potential risks vary with the wide 
variety of LDTs.  Thus, FDA believes that a risk-based approach to regulatory oversight 
of LDTs is appropriate and necessary to protect patient safety. 
 
Consistent with the draft guidance entitled Framework for Regulatory Oversight of 
Laboratory Developed Tests (LDTs) (LDT Framework Guidance Document) that is 
being distributed for comment in coordination with this document, FDA intends to 
enforce certain device requirements for LDTs and device manufacturer requirements for 
laboratories that manufacture, prepare, propagate, compound, assemble or process 
                                                           
3 Section 201(h) of the FD&C Act provides: 
(h) The term "device" (except when used in paragraph (n) of this section and in sections 301(i), 403(f), 
502(c), and 602(c)) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro 
reagent, or other similar or related article, including any component, part, or accessory, which is-- 
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to 
them, 
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or 
prevention of disease, in man or other animals, or 
(3) intended to affect the structure or any function of the body of man or other animals, and which does not 
achieve its primary intended purposes through chemical action within or on the body of man or other 
animals and which is not dependent upon being metabolized for the achievement of its primary intended 
purposes. 
  5  Contains Nonbinding Recommendations 
Draft - Not for Implementation 
 
 
LDTs.4  FDA intends to collect information regarding LDTs currently being offered for 
clinical use through a notification process.  In addition, FDA intends to enforce the 
requirements under 21 CFR Part 803 for laboratories that are also manufacturers of LDTs 
for reporting safety issues related to LDTs to provide a mechanism for collecting 
information on any known or suspected adverse events related to the use of an LDT.  The 
FDA believes that this is the appropriate regulatory approach to adopt to achieve the 
desired public health goal of assuring that these IVD tests used in the provision of health 
care, regardless of the manufacturer, provide reasonable assurance of safety and 
effectiveness.   
 
C. Scope 
 
The goal of this document is to explain to clinical laboratories how they should 
appropriately notify the FDA of all of the LDTs manufactured, prepared, propagated, 
compounded, or processed by their laboratories.  This guidance also provides information 
about how to comply with FDAs MDR requirements as they apply to LDTs.   
 
D. Notification to FDA of all LDTs Manufactured by a 
Laboratory 
 
The notification process described below is intended to collect information on the LDTs 
being used by laboratories in order to classify LDTs by risk level and assist FDA in 
determining its priorities in enforcing premarket review requirements for different types 
of LDTs.   
 
The specific information that should be provided with each LDT notification is described 
in Appendix A of this document.  Information should be submitted on-line through the 
FDA website.  Notification is expected to occur once for each LDT, although if 
significant changes are made to an LDT, additional notification should be provided.  
 
Completion of this notification does not constitute compliance with registration and 
listing requirements, nor will the laboratory be considered to be registered and listed with 
the FDA. 
 
Notification Process for LDTs Currently on the Market and New LDTs on the 
Market within 6 Months after Publication of the Final LDT Framework Guidance 
Document: 
For all LDTs on the market on the date of publication of the final version of the LDT 
Framework Guidance Document, and new LDTs that come on the market for the 
                                                           
4 See 21 CFR 807.3(d) for definition of these terms.  This guidance document uses manufacture to 
encompass all of these terms. 
  6  Contains Nonbinding Recommendations 
Draft - Not for Implementation 
 
 
following 6 months after publication of the document, FDA intends to continue to 
exercise enforcement discretion with respect to the registration and listing requirements, 
as described in 21 CFR Part 807, for owners and operators of laboratories5 that 
manufacture, prepare, propagate, compound, assemble, or process6 LDTs, provided that 
these laboratory owners/operators notify the Agency and provide basic information 
regarding all of the LDTs they manufacture within 6 months of publication of the final 
LDT Framework Guidance Document.   
 
Notification for New LDTs on the Market after the 6-month Period following 
Publication of the Final LDT Framework Guidance Document: 
Starting 6 months after publication of the final version of the LDT Framework Guidance 
Document, FDA intends to continue to exercise enforcement discretion with respect to 
the registration and listing requirements, as described in 21 CFR Part 807, for owners and 
operators of laboratories7 that manufacture, prepare, propagate, compound, assemble, or 
process8 new LDTs, provided that these laboratory owners/operators notify the Agency 
and provide basic information regarding the new LDTs they manufacture prior to offering 
these LDTs for clinical use.   
 
Notification to FDA regarding Significant Changes to LDTs: 
When a laboratory makes a significant change to the marketed intended use of an LDT 
for which they have previously provided notification, the LDT will be considered by the 
FDA to be a new LDT.9  Therefore, a new notification should be provided within 6 
months of publication of the final LDT Framework Guidance Document or prior to 
offering that LDT for clinical use if offered after that 6-month period.  This notification is 
especially important for those changes in marketed intended use that increase the risk of 
the device.  Additionally, FDA urges laboratories that make other significant 
modifications to LDTs after the initial notification to re-submit notification data to FDA 
to communicate such changes (see section D.5.(e) of the LDT Framework Guidance 
Document for additional information on significant device modifications). 
 
Laboratories That Do Not Provide Notification: 
Laboratories that do not opt to notify the Agency and provide basic information regarding 
each of the LDTs manufactured in their laboratory within the abovementioned 
timeframes or that do not opt to notify the Agency and provide basic information after a 
significant change is made to the marketed intended use of their LDT will not be within 
the scope of FDAs enforcement discretion policy with respect to the registration and 
                                                           
5 Laboratory refers to a facility with a single CLIA certificate as described in 42 CFR 493.43(a)-(b).  (See 
also 42 CFR 493.55).  
6 See 21 CFR 807.3(d) for definition of these terms.  This guidance document uses manufacture to 
encompass all of these terms. 
7 See supra note 3.  
8 See supra note 4. 
9 For purposes of this guidance, FDA uses the term marketed intended use to refer to the use(s) of a test 
that a laboratory promotes or includes in any applicable labeling.  Although FDA generally considers new 
devices to include other types of modifications to an existing device (e.g., technological changes), for the 
purposes of this subsection only, new LDTs do not include other types of modifications to an existing LDT.   
  7  Contains Nonbinding Recommendations 
Draft - Not for Implementation 
 
 
listing requirements codified in 21 CFR Part 807.  Such laboratories would fall within the 
agencys normal enforcement approach with respect to the registration and listing 
requirements.  These requirements include payment of the required registration fee 
(Section 738(a)(3) of the FD&C Act; 21 U.S.C. 379j(a)(3)), registration of each 
establishment10 with the FDA, and listing of the devices manufactured in these facilities 
(21 CFR 807.20(a)). 
 
Instructions for Establishments That Are Involved in the Manufacture of Other 
Medical Devices, in Addition to LDTs: 
FDA intends to exercise enforcement discretion with respect to registration and listing 
requirements solely for laboratories that manufacture prepare, propagate, compound, 
assemble, or process only LDTs.  Establishments that manufacture, prepare, propagate, 
compound, assemble, or process other medical devices, in addition to LDTs, must 
comply with the registration and listing requirements codified in 21 CFR Part 807, 
including payment of the required registration fee (Section 738(a)(3) of the FD&C Act; 
21 U.S.C. 379j(a)(3)), registration of their establishment with the FDA and listing of the 
devices manufactured in these facilities (21 CFR 807.20(a)), including LDTs.   FDA does 
not believe that enforcement discretion is warranted for such laboratories because FDA is 
already enforcing registration and listing requirements for such establishments based 
upon their activities related to other medical device products.    
 
When completing registration and listing with the FDA, owners and operators of these 
establishments should provide listing information for their LDT by utilizing the LDT 
product code, OQS into the FDAs Unified Registration and Listing System (FURLS). 
This product code is specific for LDTs that have not received product codes through the 
FDA clearance or approval process. 
 
Registration and Listing Requirements for LDTs that Seek FDA Clearance or 
Approval 
FDA intends to enforce registration and listing requirements for establishments that 
manufacture, prepare, propagate, compound, assemble or process an LDT once a 
laboratory has submitted a premarket submission (e.g., premarket approval application or 
a premarket notification submission (510(k))) to the Agency for the LDT.  A laboratory 
may seek premarket clearance/approval for its LDT either because FDA has announced 
its intent to enforce premarket review requirements for that LDT category (see draft LDT 
Framework Guidance Document) or because the laboratory has chosen to do so.   
 
Manufacturers of LDTs that receive FDA clearance or approval should not list these 
cleared or approved medical device(s) under the OQS product code.  Rather, the 
establishment should utilize the product code that FDA assigns to their medical device in 
the clearance/approval of their premarket submission.  These manufacturers should only 
use the OQS code when listing LDTs that are not cleared or approved. 
 
                                                           
10 See 21 CFR 807.3(c) for definition of establishment. 
  8  Contains Nonbinding Recommendations 
Draft - Not for Implementation 
 
 
E. Medical Device Reporting for LDTs 
Overview of Medical Device Reporting (MDR) Requirements 
Medical Device Reporting (MDR) requirements are codified in 21 CFR Part 803.  One 
objective of the MDR regulation is to provide a mechanism for FDA and device 
manufacturers to identify and monitor significant adverse events involving medical 
devices so that problems may be detected and corrected in a timely manner. This 
regulation implements reporting requirements for importers, manufacturers, and user 
facilities. 
Laboratories have always been subject to certain provisions of the MDR regulation in 
their capacity as device user facilities11 (21 CFR 803.10(a), 803.30, 803.32, and 803.33).  
User facilities are required to report to the device manufacturer, if known, and to FDA no 
more than 10 work days after the day they become aware of information from any source 
that reasonably suggests that a device has caused or may have caused or contributed to 
the death of a patient of their facility.  21 CFR 803.30(a)(1).  User facilities are required 
to submit a report to the device manufacturer12 no later than 10 work days after the day 
they become aware of information from any source that a device has or may have caused 
or contributed to a serious injury to a patient of their facility.  21 CFR 803.30(a)(2).  If 
the device manufacturer is not known, user facilities must report to FDA.  21 CFR 
803.30(a)(2).  User facilities are also required to submit annual reports (see 21 CFR 
803.33) to FDA that include information for each reportable event that occurred during 
the annual reporting period.   
 
In addition to enforcing laboratories obligations to report adverse events as user 
facilities, FDA also intends to enforce manufacturer reporting requirements for 
laboratories that manufacture13 LDTs in accordance with 21 CFR Part 803, including 21 
CFR 803.10(c), 21 CFR 803.50, and 21 CFR 803.52.  The following guidance is intended 
to assist clinical laboratories in submitting adverse event reports as manufacturers and to 
meet their other requirements as manufacturers under 21 CFR Part 803, including 21 
CFR 803.17, 21 CFR 803.18, 21 CFR 803.53 and 21 CFR 803.56: 
 
1. Manufacturer Reporting Requirements 
 
                                                           
11 A device user facility is defined under 21 CFR Part 803.3 as a hospital, ambulatory surgical facility, 
nursing home, outpatient diagnostic facility, or outpatient treatment facility. . . The focus of this guidance 
document is laboratories offering LDTs. 
12 Note that, for LDTs, the laboratory is both the user facility and the manufacturer. 
13 In accordance with 21 CFR 803.3 a manufacturer is any person who manufactures, prepares, 
propagates, compounds, assembles, or processes a device by chemical, physical, biological or other 
procedure.  This definition therefore encompasses laboratories that design and manufacture LDTs, or 
those that significantly modify FDA cleared/approved devices (e.g., modify performance or intended use). 
  9  Contains Nonbinding Recommendations 
Draft - Not for Implementation 
 
 
The MDR regulation requires the manufacturer of a medical device to submit reports to 
the FDA whenever they become aware14 of information that reasonably suggests that a 
device they market may have caused or contributed to15 a death or serious injury16, or has 
malfunctioned and the malfunction would be likely to cause or contribute to a reportable 
death or serious injury should it recur. 21 CFR 803.50. 
 
Manufacturers (21 CFR 803.3), including foreign manufacturers, of medical devices are 
required to: 
 
  Submit MDR reportable events involving their medical devices as described in 21 
CFR 803.10(c), 21 CFR 803.50, and 21 CFR 803.52; 
 
  Submit 5-day reports as described in 21 CFR 803.53; 
 
  Submit supplemental reports as described in 21 CFR 803.56; 
 
  Conduct an investigation of each event and evaluate the cause of the event as 
described in 21 CFR 803.50(b)(3);  
 
  Develop, maintain, and implement written MDR procedures described in 21 CFR 
803.17; and  
 
  Establish and maintain complete files for all MDR events concerning adverse 
medical device events as described in 21 CFR 803.18(a) and (e). 
 
When to submit a report 
All clinical laboratories manufacturing LDTs for clinical use are required as medical 
device manufacturers to submit MDR reports to the FDA as follows: 
  Submit reports of individual adverse events no later than 30 calendar days after 
the day that the laboratory becomes aware of information from any source, that 
reasonably suggests that an LDT they manufacture:  
  May have caused or contributed to a death or serious injury or 
  Has malfunctioned and this device or similar LDT they manufacture would be 
likely to cause or contribute to a death or serious injury, if the malfunction 
were to recur.  (21 CFR 803.50(a)) 
                                                           
14 A manufacturer has become aware of an event when an employee of the entity required to report has 
acquired information to reasonably suggest a reportable adverse event has occurred. (21 CFR 803.3). 
15 The term caused or contributed to means that a death or serious injury was or may have been attributed 
to a medical device, or that a medical device was or may have been a factor in a death or serious injury, 
including events occurring as a result of failure, malfunction, improper or inadequate design, manufacture, 
labeling, or user error. (21 CFR 803.3) 
16 Serious Injury means an injury or illness that is life-threatening, results in permanent impairment of a 
body function or permanent damage to a body structure, or necessitates medical or surgical intervention to 
preclude permanent impairment of a body function or permanent damage to a body structure. (21 CFR 
803.3) 
  10  Contains Nonbinding Recommendations 
Draft - Not for Implementation 
 
 
  Submit reports of individual adverse events no later than 5 working days after the 
day that the laboratory becomes aware of a reportable event that necessitates 
remedial action to prevent an unreasonable risk of substantial harm to the public 
health; or a reportable event for which the FDA has made a written request. (21 
CFR 803.53) 
  Submit supplemental reports within 1 month of the day the laboratory receives 
reportable information that was not submitted in an initial report. (21 CFR 
803.56) 
 
How to submit a report 
Laboratories reporting on adverse events related to their LDTs must complete the 
MedWatch 3500A form available at  
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM048334.p
df then mail the completed form to FDA.17 
Submit MedWatch 3500A forms to: 
Food and Drug Administration  
Center for Devices and Radiological Health  
Medical Device Reporting  
PO Box 3002  
Rockville, MD 20847-3002  
These forms can also be submitted electronically.  For electronic filing instructions please 
see Section E, question 14.  
 
Please note:  Laboratories that have not registered and listed with the FDA, but that have 
notified the FDA of their LDTs using the process described in the guidance should utilize 
their notification confirmation number, instead of a FDA registration number, to create an 
appropriate Mfr Report Number (top right hand corner of MedWatch 3500A form). 
 
Additionally, laboratories should include the term procode OQS (unless the LDT has 
been cleared or approved by FDA, in which case the procode assigned in the 
clearance/approval process should be used) in the section of the MedWatch 3500A form 
entitled D. Suspect Medical Device subsection D.4 Other.  
 
The MDR report (MedWatch 3500A form) must contain all the information described in 
21 CFR 803.52 that is known or reasonably known to the clinical laboratory as a 
manufacturer.  Information reasonably known includes any information that: 
 
                                                           
17 The MDR regulation in 21 CFR Part 803 was amended on February 14, 2014, to require device 
manufacturers and importers to submit MDRs (including supplemental reports) to the FDA in electronic 
format as specified in the amended rule.  79 FR 8832.  The amended rule takes effect on August 14, 2015.  
Id.  Once the amended rule takes effect, LDT manufacturers must submit MDRs (including supplemental 
reports) to the FDA in electronic format as specified in the amended rule unless FDA grants an exemption 
under 21 CFR 803.19.  Id. 
  11  Contains Nonbinding Recommendations 
Draft - Not for Implementation 
 
 
  Can be obtained by contacting a user facility, importer, or other initial reporter; 
 
  Is in the possession of the manufacturer; or 
 
  Can be obtained by analysis, testing, or other evaluation of the device. 
 
21 CFR 803.50(b). 
 
Instructions for completing specific items on the MedWatch 3500A form can be found at:  
http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/UCM
387002.pdf. 
 
The coding manual can be found at: 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocument
s/ucm106737.htm. 
 
2.  Requirement for developing, maintaining and implementing written MDR 
procedures 
 
As is the case with other medical device manufacturers, clinical laboratories 
manufacturing LDTs for clinical use must develop, maintain, and implement written 
MDR procedures.  21 CFR 803.17.  Specifically, these procedures should include internal 
systems that provide instructions for: timely and effective identification, communication, 
and evaluation of events that may be subject to MDR requirements; a standardized 
review process or procedure that assists in determining when an event meets MDR 
reporting criteria; and timely transmission of complete MDR reports to the FDA.  21 
CFR 803.17(a). 
 
Further, these procedures must include instructions for how the clinical laboratory will 
address documentation and record keeping requirements for: information that was 
evaluated to determine if an event was reportable; all medical device reports and 
information submitted to the FDA; any information that was evaluated for the purpose of 
preparing the submission of annual reports; and systems that ensure access to information 
that facilitates timely follow-up and inspection by FDA.  21 CFR 803.17(b). 
 
Laboratories, as manufacturers, are also required to establish and maintain MDR event 
files, required by 21 CFR 803.18. 
 
For additional guidance on the MDR regulation and the reporting requirements, refer to 
the document titled Medical Device Reporting for Manufacturers at: 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocument
s/ucm094529.htm. 
 
  12  Contains Nonbinding Recommendations 
Draft - Not for Implementation 
 
 
Reporting Adverse Events as a User Facility and as a Manufacturer 
 
1.  What are the basic adverse event reporting obligations for user facilities and 
manufacturers? 
A. Reports of individual adverse events required for user facilities and manufacturers 
under 21 CFR Part 803: 
User facilities and manufacturers report individual adverse events to FDA under a 
uniform, unified reporting system. Both user facilities and manufacturers report 
adverse events on the same MedWatch 3500A form, the "Medication and Device 
Experience Report." 21 CFR 803.11 (You can find a copy of the Mandatory 
MedWatch report form at 
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM0483
34.pdf). 
When a user facility receives information about a reportable adverse event, it must 
report the event to FDA and/or the manufacturer after it becomes aware of the 
adverse event. 21 CFR 803.30.  The user facility fills out certain parts of the 
MedWatch 3500A form and forwards copies of the form to both FDA and the 
manufacturer within ten (10) work days after the day the user facility becomes aware 
if the adverse event involves a death. If the adverse event involves a serious injury, 
the user facility is required to report the event to the manufacturer within ten (10) 
work days after the day the user facility becomes aware of the event.  21 CFR 803.30.  
If the identity of the manufacturer is unknown, the user facility must report the 
serious injury to FDA within ten (10) work days after the day the user facility 
becomes aware of the event.  21 CFR 803.30. 
The manufacturer, after becoming aware of the reportable event from the user facility, 
further investigates the event and provides additional information on the MedWatch 
3500A form. 21 CFR 803.50.  The manufacturer must submit a completed MedWatch  
3500A form to FDA within thirty (30) calendar days after the day it becomes aware 
of the adverse event. 21 CFR 803.50.  A manufacturer also is obligated to submit a 
MedWatch 3500A form to FDA within five (5) work days after the day it becomes 
aware of a reportable MDR event that requires remedial action in accordance with 21 
CFR 803.53. This requirement is further discussed in question 6D, below.  21 CFR 
Part 803, Subpart E. 
B.  Other adverse event reports required for user facilities: 
User facilities must complete and submit to FDA an annual report by January 1 of 
each year. 21 CFR 803.33.  Under 21 CFR 803.33, the information in the annual 
report must include: 
  13  Contains Nonbinding Recommendations 
Draft - Not for Implementation 
 
 
  User facilitys Center for Medicare and Medicaid Services (CMS) provider 
number or the number assigned by FDA for reporting purposes;  
  Reporting year;  
  Facility name and complete address;  
  Total number of reports attached or summarized;  
  Date of the annual report and the lowest and highest user facility report number of 
medical device reports submitted during the report period (for example, 
123456790-2001-0001 through 0895);  
  Name, position title, and complete address of the user facility contact person 
responsible for reporting to us and whether that person is a new contact for you; 
and  
  Information for each reportable event that occurred during the annual reporting 
period (see 21 CFR 803.33 (7) (i-vi) for details).  
The annual report information must be submitted to the Agency using FDA form 
3419 or its electronic equivalent as approved by FDA under 21 CFR 803.14.  21 CFR 
803.33.  If no reports are submitted to either FDA or manufacturers during these time 
periods, no annual report is required.  21 CFR 803.33(c). 
C.  Other adverse event reports required for manufacturers: 
Manufacturers are required to submit Supplemental Reports of required information 
that was not known or was not available at the time of the initial report. 21 CFR 
803.56.  This information must be submitted within one (1) month of the day the 
manufacturer receives the information.  21 CFR 803.56.  
 
2.  How does being a manufacturer of a device change my adverse event reporting 
obligations? 
 
  As an entity that is a manufacturer of a device in addition to being a user facility, your 
clinical laboratory is now also subject to the manufacturers adverse event reporting 
requirements. Accordingly, for adverse events involving LDTs, you must fulfill 
both the 21 CFR Part 803 reporting requirements of a user facility and a 
manufacturer.  21 CFR 803.3.  This guidance document is intended to assist you in 
determining when a clinical laboratory must fulfill both the user facility and the 
manufacturer reporting requirements of 21 CFR Part 803 and when you only have to 
fulfill the user facility reporting requirements of 21 CFR Part 803.  
3.  What are the major differences between the user facility and manufacturer 
adverse event reporting requirements under 21 CFR Part 803? 
 
There are several significant differences between reporting an adverse event to FDA 
as a user facility versus as a device manufacturer.  Device manufacturers are required 
to report serious injuries to FDA rather than to the manufacturer; fill out additional 
sections of MedWatch 3500A form; report certain device malfunctions; and submit 
  14  Contains Nonbinding Recommendations 
Draft - Not for Implementation 
 
 
five (5) day remedial action event reports to the Agency. In addition to filing the 
MedWatch 3500A form, manufacturers are required to submit Supplemental MDR 
Reports as appropriate. 
4.  How do I know if I am required to report as a manufacturer or a user facility? 
 
  Whether you are required to fulfill the user facility adverse event reporting 
requirements only, or the manufacturer reporting requirements and the user facility 
requirements depends on whether the adverse event involved an LDT.  The answer to 
whether you report solely as a user facility or whether you also must report as a 
manufacturer depends on your answer to the following questions: 
 
A.  Does the reportable event involve an LDT that was manufactured by your 
laboratory?   
If the reportable event involved an LDT that your facility manufactured, even if the 
LDT in question contained critical components, such as Analyte specific reagents 
(ASRs), that were not manufactured by your laboratory (e.g. FDA cleared/approved 
devices that have been modified by your laboratory in a way that affects intended use 
or IVD performance), then you have to fulfill the reporting requirements of a 
manufacturer and a user facility.  21 CFR 803.3. 
B. Does the reportable event involve an IVD or other medical device that was not an 
LDT manufactured by your laboratory? 
 
If the reportable event involved an IVD or other medical device that was not an LDT 
that you manufactured, you only have to fulfill the reporting requirements of a user 
facility.  21 CFR 803.3. 
5.  What types of adverse events must I report when the event is not related to an 
LDT manufactured by my clinical laboratory? 
   
  You are required to fulfill user facility adverse event reporting requirements for: 
 
A.  Deaths: 
As a user facility, you are obligated to report adverse events to FDA, and to the 
manufacturer, if known, within ten (10) work days after the day you become aware of 
information that reasonably suggests that a device has or may have caused or 
contributed to the death of a patient of your facility.  21 CFR 803.30(a)(1). 
 
B.  Serious Injuries: 
As a user facility, you are obligated to report adverse events to the manufacturer, or to 
FDA if the identity of the manufacturer is not known, within ten (10) work days after 
the day you become aware of information that reasonably suggests that a device has 
or may have caused or contributed to a serious injury to a patient of your facility.  
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21 CFR 803.30(a)(2). 
6.  What types of events must I report as a manufacturer when the event is related 
to an LDT manufactured by my clinical laboratory? 
 
LDTs are medical devices under the FD&C Act (Section 201(h) of the FD&C Act; 21 
U.S.C. 321(h)); therefore, a clinical laboratory that manufactures and offers an LDT 
for clinical use is considered to be a manufacturer of a medical device. As such, the 
clinical laboratory must fulfill the manufacturer reporting requirements under 21 CFR 
803:  
A.  Deaths: 
As the LDT manufacturer, you are obligated to report adverse events to FDA within 
thirty (30) calendar days after the day you become aware of information that 
reasonably suggests that an LDT manufactured by your clinical laboratory has or may 
have caused or contributed to the death.  21 CFR 803.50(a)(1). 
B.  Serious Injuries: 
As an LDT manufacturer, you are obligated to report adverse events to FDA within 
thirty (30) calendar days after the day you become aware of information that 
reasonably suggests that an LDT manufactured by your clinical laboratory has or may 
have caused or contributed to a serious injury.  21 CFR 803.50(a)(1). 
C.  Malfunctions: 
As an LDT manufacturer, you are obligated to report adverse events to FDA within 
thirty (30) calendar days after the day you become aware of information that 
reasonably suggests that the LDT manufactured by your clinical laboratory has 
malfunctioned and such device (LDT) or similar device (LDT) also manufactured by 
your clinical laboratory would be likely to cause or contribute to a death or serious 
injury, if the malfunction were to recur.  21 CFR 803.50(a)(2). 
D.  Remedial actions; requests: 
As an LDT manufacturer, you are obligated to report adverse events to FDA within 
five (5) work days after the day you become aware of: 
1.  a reportable event(s) that necessitates remedial action to prevent an 
unreasonable risk of substantial harm to the public health, or  
2.  a reportable event(s) for which FDA has made a written request.  
 
21 CFR 803.53(a) and (b). 
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7.  As an LDT manufacturer, I am obligated to report deaths to FDA within 30 
calendar days (see question 6A, above). However, as a user facility, I am 
obligated to report deaths to FDA within 10 work days (See question 5A, above).  
Do I complete two separate MedWatch 3500A forms in order to meet the 
different reporting obligations for the same event? 
 
To avoid filing the same event twice when the event involves a reportable death, you 
may complete all medical device sections (skip section C) of the MedWatch 3500A 
form and submit the completed form to the Agency within ten (10) work days. 
As the user facility, you must complete sections A  F (skip section C) of the 
MedWatch 3500A form.  21 CFR 803.32.  As the LDT manufacturer, you must 
complete sections A, B, D, E, G, and H of the MedWatch 3500A form.  21 CFR 
803.52.  Thus, as both, you must complete sections A, B, and D-H of the MedWatch 
3500A form.  21 CFR 803.32 and 21 CFR 803.52. 
8.  What is the definition of "Serious Injury"? 
"Serious injury" is defined as an injury or illness that: 
  is life-threatening;  
  results in permanent impairment of a body function or permanent damage to 
body structure; or  
  necessitates medical or surgical intervention to preclude permanent 
impairment of a body function or permanent damage to a body structure.  21 
CFR 803.3. 
9.  What is the definition of "Malfunction"? 
 
  "Malfunction" is defined as the failure of a device to meet its performance 
specifications or otherwise perform as intended.  21 CFR 803.3.  Performance 
specifications include all claims made in the labeling for the device. 21 CFR 803.3.  
The intended performance of a device refers to the intended use for which the device 
is labeled or marketed.  21 CFR 801.4 and 21 CFR 803.3.   
 
10. As a user facility, which sections of the MedWatch 3500A form must I complete 
for a reportable adverse event? 
 
A.  On the upper right-hand corner on the front page of the MedWatch 3500A form, 
enter your user facility number under UF/Dist report #. The UF # is a 
combination of your organizations CMS number (or a number FDA assigned to 
your organization), the 4-digit calendar year in which the report is submitted, and 
a 4-digit sequence number of the report submitted during the year (e.g., 
1234567890-2011-0001, 1234567890-2011-0002, etc.). 
 
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B.  Complete all items in section A. Patient information. 
C.  Complete all items in section B. Adverse event or product problem. 
  (Note: skip section C. Suspect medication(s).) 
 
D.  Complete all items in section D. Suspect medical device. Note that specific device 
identification information should be entered exactly as it appears on the device or 
on the device labeling.   
 
E.  Complete all items in section E. Initial reporter. The initial reporter is the person 
who provided the information about the adverse event to the user facility. 
 
F.  Complete all items in section F. For use by user facility/distributor- devices only. 
 
21 CFR 803.20 and 21 CFR 803.32. 
 
11. As the manufacturer, which sections of the MedWatch 3500A form must I 
complete for a reportable adverse event that involves an LDT that my clinical 
laboratory manufactured?  
 
A.  On the upper right-hand corner on the front page of the MedWatch 3500A form, enter 
your Mfr. report #. The mfr. report # is composed of either the registration number 
that FDA assigned to your laboratory when you registered and listed with the Agency 
as a manufacturer, or the notification confirmation number that you were assigned 
upon notifying the Agency of your LDTs, the 4-digit calendar year in which the 
report is submitted, and the 5-digit sequence number for each report submitted during 
the year (e.g., 9876543210-2011-00001, 9876543210-2011-00002, etc.). You also 
must enter your user facility report number under UF/Dist report # of the MedWatch 
3500A form (see 10A above). 
 
B.  Complete all items in section A. Patient information. 
C.  Complete all items in section B. Adverse event or product problem. 
  (Note: skip section C. Suspect medications(s).) 
 
D.  Complete all items in section D. Suspect medical device. For item D.3. 
Manufacturer name and address, enter the name and address of the laboratory 
that manufactures the LDT. For item D.4 Other # enter Procode OQS if your 
LDT is not approved or cleared by the FDA.  If your LDT is approved or cleared 
by the FDA, please enter Procode and then the product-specific procode that 
was assigned to your device. 
 
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E.  Complete all items in section E. Initial reporter. The initial reporter is the person 
who provided the information about the adverse event to the user facility or 
manufacturer. 
F.  Section F. For use by user facility/distributor-devices only. If you are considered 
to be both the user facility and the manufacturer for the event, then you should fill out 
this section as the user facility.  For malfunction events not submitted by the user 
facility, the manufacturers submission should not include section F of the MedWatch 
3500A form.  Corrected or missing information for Section F, including relevant 
patient problem and device problem codes, should be included in the Section H.11 
(Corrected Data) section of the MedWatch 3500A form provided by the 
manufacturer. 
1.  F.13. Report sent to manufacturer? The term "manufacturer" in this block 
refers to the LDT manufacturer.  
2.  F.14: Manufacturer name/address. The term "manufacturer" in this block 
refers to the LDT manufacturer.  Because this information should also be 
entered in section G.1 Contact office  name/address (& manufacturing site 
for devices), you may enter in section F.14 Manufacturer name/address, "see 
G.1." 
 
G.  Complete all items in section G. All manufacturers.  
1.  G.1: Contact office  name/address (& manufacturing site for devices). 
Information in this block refers to the LDT manufacturer; therefore, enter the 
contact office, name, and address of the laboratory that is submitting the 
report of the LDT event.  
2.  G.4: Date received by manufacturer (mo/day/yyyy). This is the date that the 
laboratory became aware of the adverse event.  
3.  G.5, 6, and 8. These blocks are not applicable to medical devices.  
4.  G.7: Type of report. Only three (3) report types are applicable to LDT 
manufacturers: 5-day, Initial (i.e., 30-day reports), and Follow-up. Select the 
report type that is applicable to the event that you are reporting. 
5.  G9: Manufacturer Report Number. G9 should match the manufacturer report 
number that you assigned to the event in the upper right hand corner of your 
MedWatch 3500A form, and should appear on any additional pages you might 
attach to the MedWatch 3500A form. 
H.  Complete all blocks in section H. Device manufacturers only. As the LDT 
manufacturer, you must complete all sections regardless of where the device 
analysis was performed.  
1.  H.4: Device manufacturing date (mo/yyyy). For the purpose of this block, the 
manufacturing date is the date that the LDT was manufactured by your 
clinical laboratory.   Note:  in cases where components of the LDT were 
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manufactured on different dates, FDA considers the device manufacturing 
date to be the date the last component of the LDT was manufactured by the 
laboratory and/or qualified as suitable for use. 
2.  H.7: If remedial action initiated, check type. Select the most appropriate 
remedial action(s) that apply. Under the MDR regulation a remedial action is 
any action, other than routine maintenance or servicing of a device, necessary to 
prevent recurrence of an MDR reportable event.  21 CFR 803.3.  FDA does not 
consider an action taken to correct only a single device involved in a specific 
MDR reportable event to be a remedial action.   
21 CFR 803.20, 21 CFR 803.32, and 21 CFR 803.52. 
12. When do I have to file reports of corrections and removals? 
Under 21 CFR Part 806, you are required to submit a written report to FDA within 
ten (10) work days of initiating a correction or removal action that was taken: 
  to reduce a risk to health posed by the device; or  
  to remedy a device problem which may present a risk to health  
 
The Reports of Correction and Removal regulation, 21 CFR Part 806, specifies the 
information that must be included in this report, as well as the format the firm should 
follow when assigning the correction/removal reporting number.  This number 
consists of the registration number for the responsible firm, the date of the report 
using MM/DD/YY format, a 3 digit sequential number for each report made on that 
date (i.e., 001, 002, 003, etc.), and the report type designation (i.e., C for a report of 
correction or R for a report of removal).   21 CFR 806.10. 
You are reminded that a report of correction or removal should be reported to the 
appropriate FDA district office within 10 working days of initiating such correction 
or removal, and should contain the information required under 21 CFR 806.10. 
13. If I file an adverse event report on the MedWatch 3500A form for an adverse 
event related to an LDT that I manufactured, do I have to file a corrections and 
removals report too? 
 
The MedWatch 3500A form does not include all of the data elements required by 21 
CFR Part 806 and therefore cannot replace the corrections and removals report.  
However, you may attach your 21 CFR Part 806 report to the MedWatch 3500A 
form.  
 
Otherwise, the 21 CFR Part 806 report should be sent to the appropriate FDA District 
Office, and the MedWatch 3500A form should be submitted to FDA Headquarters.  
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14. Can I submit my reports electronically?  
Yes, you can file your initial and supplemental reports with FDA in an electronic 
format.  Information on sending initial and supplemental reports electronically is 
available at http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm.  
Instructions for electronic reporting are available at the electronic Medical Device 
Reporting (eMDR) home page at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequ
irements/ReportingAdverseEvents/eMDR%E2%80%93ElectronicMedicalDeviceRep
orting/default.htm.   
15. What are the supplemental reports that I must submit as an LDT 
manufacturer? 
 
As an LDT manufacturer, you are obligated to file a supplemental report, using the 
MedWatch 3500A form, with FDA within one month of receiving additional or 
updated information on an adverse event that was not available or known at the time 
you submitted the initial MedWatch 3500A form. 21 CFR 803.56.  You should report 
the supplemental information by providing the same user facility report number and 
manufacturer report number that was entered on the original submission by 
completing blocks G.7 (Type of report) and G.9 (Mfr. report number) and check the 
appropriate code in section H.2. Only new, changed, or corrected information should 
be entered on the MedWatch 3500A form. Information that was previously submitted 
should not be repeated. A detailed description of supplemental reporting requirements 
is provided in 21 CFR 803.56. 
 
16. Are there additional MDR requirements that apply to user facilities that 
manufacture LDTs? 
Yes. You need to amend your current MDR procedures to comply with your MDR 
reporting obligations as both an LDT manufacturer and user facility.  21 CFR 803.17. 
User facilities and manufacturers are required to establish and maintain MDR event 
files.  21 CFR 803.18.  For adverse events involving LDTs manufactured by your 
clinical laboratory, you need to incorporate the additional requirements for 
manufacturers under 21 CFR 803.18(e). 
 
17. How may I request exemptions or alternative reporting options as an LDT 
manufacturer? 
Under 21 CFR 803.19(b) and (c), you may, as an LDT manufacturer, request an 
exemption from any or all of the reporting requirements of 21 CFR Part 803. FDA 
may, at its discretion, grant an exemption or alternative form of reporting adverse 
  21  Contains Nonbinding Recommendations 
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events. When the Agency grants an exemption or alternative form of reporting, it may 
impose other reporting requirements to ensure the protection of public health. 
For information, contact the MDR Policy Branch at MDRPolicy@fda.hhs.gov 
 
18. Where can I get additional information on user facility or manufacturer MDR 
reporting requirements? 
Resources: 
Find reporting information at: 
  MedWatch: The FDA Safety Information and Adverse Event Reporting Program 
(http://www.fda.gov/Safety/MedWatch/default.htm)  
  How to Report a Problem (Medical Devices) 
(http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm) 
  MedWatch Coding Tools/Resource Files 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Postmarket
Requirements/ReportingAdverseEvents/EventProblemCodes/default.htm)  
  Medical Device Reporting (MDR) modules on the Center for Devices and 
Radiological Health (CDRH) Learn page available at: 
(http://www.fda.gov/training/cdrhlearn/default.htm).    
You may also submit questions on MDR reporting to the MDR Policy Branch (MPB) at: 
MDRPolicy@fda.hhs.gov; or you may refer to the web site 
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 
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APPENDIX A:  FDA Notification Data Elements 
 
To appropriately notify the FDA of all LDTs manufactured at an establishment, the 
owner/operator should provide information on the following data elements for each LDT 
manufactured at their establishment.  Notification information should be submitted on-
line through the FDA website.   
 
1.  Laboratory Name 
Indicate the legal name for your laboratory as you wish it to appear in FDAs 
records. 
 
2.  Laboratory Contact Email Address 
Indicate the contact email address for your laboratory as you wish it to appear in 
FDAs records. 
 
3.  Test Name 
Indicate the name of the test you are describing.  Please note that the name can 
include a trade name or a general descriptor used by the laboratory to refer to the 
test. 
 
4.  Monthly Test Volume 
Indicate the number of clinical tests the laboratory conducts using this IVD per 
month. 
 
5.  Intended Use 
Provide a brief statement describing how your test is intended to be used.  Please 
include a general description of the disease or condition that the test will provide 
information for diagnosis, treatment, prevention, cure or mitigation. Please note 
that a single test can have multiple intended uses. 
Example 1: The X urine test is an immunoassay designed for the qualitative 
determination of human chorionic gonadotropin (hCG) in urine for the 
early detection of pregnancy.  
 
Example 2: Test Y is a qualitative in vitro diagnostic test service, performed 
in a single laboratory, using the gene expression profile of fresh frozen breast 
cancer tissue samples to assess a patients risk for distant metastasis. The test 
is performed for breast cancer patients who are less than 61 years old, with 
Stage I or Stage II disease, with tumor size <=5.0cm and who are lymph node 
negative. The result of Test Y is indicated for use by physicians as a 
prognostic marker only, along with other clinicopathological factors. 
 
6.  Clinical Use of Test  
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Indicate which of the following categories demonstrate how the information 
generated by your test is intended to be used clinically.  Please indicate all of 
the terms below that apply to how the information generated by your LDT is 
intended to be used.  If the other category is chosen, please specify the type 
of clinical use intended for the test. 
 
Options: 
  Diagnosis 
  Prognosis 
  Monitoring 
  Assessment of Risk 
  Screening 
  Organism Identification 
  Therapy Selection/Monitoring 
  Other 
 
7.  What is measured or detected (i.e. analyte, measurand, etc.) 
Indicate any analytes that are measured or organisms that are detected by the test. 
 
8.  Disease/Condition for which the diagnostic device is indicated 
Indicate the type of disease or condition for which the test is used (i.e. 
cardiovascular disease, diabetes, breast cancer, etc.)  
 
9.  Patient Population 
Provide a brief description of the patient population in which the test is intended 
to be used.   
 
Example:  Patients at high risk for developing type II diabetes. 
 
10. Does the patient population include pediatric patients? (<21 years old) 
Indicate whether the LDT is intended to be used on patients under 21 years old. 
 
11. Sample Type 
Indicate all of the sample types used for the test.  Please note that a single test can 
utilize multiple sample types.  If choosing other please specify the sample type 
used for the test. 
 
Options:  
  Serum 
  Plasma 
  Urine 
  Whole Blood 
  Cerebral Spinal Fluid (CSF) 
  Bone Marrow 
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  Tissue  
  Organism Growth 
  Other 
 
12. Test Method 
Indicate all test methods used for the test.  Please note that a single test can utilize 
multiple test methods.  If choosing the other category, please specify the 
additional test methods used for this IVD. 
 
Options: 
  Serology 
  Flow Cytometry 
  Fluorescence In Situ Hybridization (FISH) 
  Genotyping/Nucleic Acid Detection (human) 
  Immunohistochemistry (IHC) 
  Immunoassay 
  Mass Spectrometry 
  Microarray (i.e. genotyping, proteomics, Array-CGH or array 
comparative genome hybridization, etc.) 
  Nuclear Acid Amplification Test (NAAT) for microbial testing 
  High Performance Liquid Chromatography (HPLC) 
  Polymerase Chain Reaction (PCR) 
  DNA Sequencing  
  Other 
 
13. Is the test a modification of an FDA cleared/approved test? 
Please indicate whether the IVD represents an FDA cleared or approved in vitro 
diagnostic test that has been modified in some way so as to affect device 
performance or intended use. 
 
14. If the test is a modification of an FDA cleared/approved test, what 
modifications were made? 
If the IVD represents an FDA cleared or approved in vitro diagnostic test that has 
been modified in some way so as to affect device performance or intended use, 
please indicate what types of modifications were made to the FDA 
cleared/approved test. Please indicate all options that apply.  If choosing other, 
please provide a brief description of the modification. 
 
Options: 
  Intended Use Change 
  Instrument Change 
  Procedure Change 
  Software Modification 
  Sample/Specimen Type Change 
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  Change in results interpretation reporting 
  Critical Assay Component Change 
  Other 
 
 
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APPENDIX B: ADVERSE EVENT REPORTING 
REQUIREMENTS  
 
   What types of  Who should receive a  What is the time frame for  Which sections of 
device-related  copy of the report?  reporting the adverse event?  the MedWatch 
adverse events must  3500A form must 
  
be reported?  be completed? 
 Deaths (21 CFR   FDA    Within 30 calendar days after the  For all reports: 
1. An LDT  803.50)  day you become aware of the   A. Patient 
that your  event.   information; 
clinical   B. Adverse 
laboratory   Serious Injuries   FDA    Within 30 calendar days after the  event or product 
manufacture (21 CFR 803.50)  day you become aware of the  problem; 
d, that is, you  event.   (Skip section C) 
 D. Suspect 
are reporting 
medical device; 
as a device   Malfunctions (21   FDA    Within 30 calendar days after the 
manufacturer  CFR 803.50)  day you become aware of the   E. Initial 
event.   reporter; 
of the LDT   G. All 
   manufacturers; 
 Remedial actions   FDA    Within 5 work days after the day 
   and 
that were taken to  you become aware of the need for 
    H. Device 
prevent an  remedial action from any 
manufacturers 
unreasonable risk  information, including any trend 
only. 
of substantial  analysis, or have received a 
harm to the  notification from FDA requesting 
public or as  5-day reports 
requested by 
FDA. (21 CFR   
803.53) 
2.  A device   Deaths (21 CFR   FDA    Within 10 work days after the day  For all reports:  
that is not an  803.30)  you become aware of the event.    A. Patient 
LDT  And  information;  
manufacture  B. Adverse 
event or product 
d by your   Device  problem; 
clinical  Manufacturer   (Skip section C) 
laboratory, 
 D. Suspect 
that is, you   Serious Injuries   Device   Within 10 work days after the day  medical device; 
are only  (21 CFR 803.30)  Manufacturer   you become aware of the event.    E. Initial 
reporting as a 
reporter; and 
user facility.  Or   F. For use by 
If you are  user 
reporting as  facility/distribu-
 FDA when the 
user facility  tor-devices 
device 
and  only.  
manufacturer is 
manufacturer unknown  
, you must 
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fulfill the   May voluntarily   FDA    Not required. Voluntary reports 
reporting  report  may be submitted at any time. 
requirements  malfunctions   Or   Link to 3500 voluntary report 
of this section  form 
https://www.accessdata.fda.gov/sc
and those   Device 
ripts/medwatch/ 
listed in  Manufacturer  
section 1 
above in this 
chart.  
  
  
 
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