Contains Nonbinding Recommendations
Draft Not for Implementation
Voluntary Malfunction Summary 
Reporting (VMSR) Program 
for Manufacturers
Draft Guidance for Industry and 
Food and Drug Administration Staff
DRAFT GUIDANCE
This draft guidance document is being distributed for comment purposes 
only.
Document issued on December 9, 2022.
You should submit comments and suggestions regarding this draft document within 60 days 
of publication in the Federal Register of the notice announcing the availability of the draft 
guidance. Submit electronic comments to https://www.regulations.gov. Submit written 
comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers 
Lane, Room 1061, (HFA-305), Rockville, MD 20852. Identify all comments with the docket 
number listed in the notice of availability that publishes in the Federal Register.
For questions about this document regarding CDRH-regulated devices, contact the Office of 
Regulatory Programs (ORP)/Division of Regulatory Programs 3 (DRP3)/Medical Device 
Reporting (MDR) Team at MDRPolicy@fda.hhs.gov. For questions about this document 
regarding CBER-regulated devices, contact the Office of Communication, Outreach, and 
Development (OCOD) at 1-800-835-4709 or 240-402-8010, or by email at ocod@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research Contains Nonbinding Recommendations
Draft Not for Implementation
Preface
Additional Copies
CDRH
Additional copies are available from the Internet. You may also send an email request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document 
number GUI00021007 and complete title of the guidance in the request.
CBER
Additional copies are available from the Center for Biologics Evaluation and Research 
(CBER), Office of Communication, Outreach, and Development (OCOD), 10903 New 
Hampshire Ave., Bldg. 71, Room 3128, Silver Spring, MD 20993-0002, or by calling 1-800-
835-4709 or 240-402-8010, by email, ocod@fda.hhs.gov or from the Internet at 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-
biologics/biologics-guidances. Contains Nonbinding Recommendations
Draft Not for Implementation
Table of Contents
I.  Introduction ........................................................................................................................ 1
II.  Background ........................................................................................................................ 2
III. Principles of Voluntary Malfunction Summary Reporting ................................................ 4
IV. Voluntary Malfunction Summary Reporting Program Eligibility and Scope .................... 4
A.  Product Code Eligibility ................................................................................................ 5
(1)  Periodic Evaluation................................................................................................. 5
(2)  Eligibility Requests................................................................................................. 6
B.  Event Types and Reporters Not Covered by the VMSR Program................................. 7
V.  VMSR Program Conditions ............................................................................................... 7
A.  Individual Reporting Conditions.................................................................................... 7
(1)  Reportable malfunction is associated with a 5-day report ...................................... 8
(2)  A reportable malfunction is the subject of certain device recalls ........................... 8
(3)  FDA has determined that individual MDR reporting is necessary to address a 
public health issue .............................................................................................................. 9
(4)  FDA has determined that a device manufacturer may not report in summary 
reporting format................................................................................................................ 10
(5)  A new type of reportable malfunction occurs for a device ................................... 10
B.  Supplemental Reports .................................................................................................. 11
C.  Summary Reporting Instructions ................................................................................. 11
(1)  Instructions using Form FDA 3500A ................................................................... 12
(2)  Reporting Schedule and Logistics ........................................................................ 13
Appendix A: Example of Malfunction Summary Reports ..................................................... 15
Multiple malfunction events with two device problems .................................................. 15 Contains Nonbinding Recommendations
Draft Not for Implementation
Voluntary Malfunction Summary 
1
Reporting (VMSR) Program 
2
for Manufacturers
3
4
Draft Guidance for Industry and 
5
Food and Drug Administration Staff
6
7
8 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
9 Administration (FDA or Agency) on this topic. It does not establish any rights for any person 
10 and is not binding on FDA or the public. You can use an alternative approach if it satisfies the 
11 requirements of the applicable statutes and regulations. To discuss an alternative approach, 
12 contact the FDA staff or Office responsible for this guidance as listed on the title page. 
13
I. Introduction
14
15 The Food and Drug Administration (FDA)is issuing this guidance document to help 
16 manufacturers better understand and use the Voluntary Malfunction Summary Reporting 
17 (VMSR) Program. It is intended to further explain, but not change,the conditions of the VMSR 
18 Program.
19
20 This guidance describes and clarifiesseveral aspects of the VMSR Program, including the 
21 FDAs approach to determining the eligibility of product codes for the program andthe 
22 conditions for submitting medical device reports (MDRs) for device malfunctions in summary 
23 format under the program. Consistent with the goals outlined in the Medical Device User Fee 
24 Amendments of 2017 (MDUFA IV) Commitment Letter,1 the VMSR Program is intended to 
25 streamline reporting of device malfunctions.  The program began in 2018 when FDA issued a 
26 notification in the Federal Register ofan order granting an alternative under 21 CFR 803.19 that 
27 permits manufacturers of devices in eligible product codes to report certain device malfunction 
28 MDRs in summary form on a quarterly basis, subject to the conditions of the alternative (Final 
29 VMSR Notice,83 FR 409732).
30
31  In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
32  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
33 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
1 Available at https://www.fda.gov/media/102699/download. 
2 Available at https://www.federalregister.gov/d/2018-17770.
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34 the word should in Agency guidances means that something is suggested or recommended, but 
35 not required.
II. Background
36
37 Eachyear, FDA receives over two million MDRs of suspected device-relateddeaths, serious 
38 injuries, and malfunctions. The MDR Program is one of the postmarket surveillance tools that 
39 FDA uses to monitor device performance, detect potential device-related safety issues, and 
40 contribute to benefit-risk assessments.3 Malfunction reports represent most of the MDRs 
41 received by FDAon an annual basis. As part of FDAs postmarket surveillance for devices, the 
42 Agency reviews theMDRs submitted by both mandatory and voluntary reporters.
43
44 FDA has determined that for many devices, it is appropriate to permit manufacturers to submit 
45 malfunction summary reports on a quarterly basis, for certain malfunctions related to devices
46 with certain product codes, instead of individual, 30-day malfunction reports. FDAs VMSR 
47 Program is intended to yield benefits for FDA,the public, and manufacturers,such as increasing 
48 transparency for the public, helping FDA to process certain malfunction reports moreefficiently, 
49 allowing both FDA and the public to identify malfunction trends more readily, and reducing the 
50 burden on manufacturers. 
51
52 MDR requirements for manufacturers are set forth in section 519 of the FD&C Act and 21 CFR 
53 Part 803. Among other things, 21 CFR Part 803requires that a manufacturer submit a report of 
54 an individual adverse event when it becomes aware of information,from any source,which 
55 reasonably suggests that one of its marketed devices malfunctioned and the malfunction of the 
56 device or a similar device marketed by the manufacturer would be likely to cause or contribute to 
57 a death or serious injury,if the malfunction were to recur (21 CFR 803.10(c)(1) and 
58  803.50(a)(2)). Throughout this guidance document, FDA refers to such malfunctions as 
59  reportable malfunctions or reportable malfunction events.  Under 21 CFR Part 803, such 
60  reports generally must be submitted to FDA within 30 calendar days after the day the 
61  manufacturer becomes aware of the reportable malfunction event (21 CFR 803.10(c)(1) and 
62  803.50).  Under some circumstances an MDR is required to be submitted within 5 work days 
63  after the day the manufacturer becomes aware of the need to submit such a report (see 21 CFR 
64  803.10(c)(2) and 803.53).   
65   
66  The FDA Amendments Act of 2007 (FDAAA4) amended section 519(a) of the FD&C Act 
67  related to the reporting of device malfunctions. FDAAA did not alter the malfunction reporting 
68 requirements for class III devices and those class II devices that are permanently implantable, 
69 life supporting, or life sustaining. Under section 519(a)(1)(B)(i) of the FD&C Act, as amended 
70 by FDAAA, manufacturers of such devices must continue to submit malfunction reports in 
71 accordance with 21 CFR Part 803 (or successor regulations), unless FDA grants an exemption or 
72 variance from, or an alternative to, a requirement under such regulations pursuant to 21 CFR 
73 803.19. FDAAA also amended the FD&C Act to require that manufacturers submit malfunction 
3 For general information on the MDR Program, see FDAs website at https://www.fda.gov/medical-
devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
4 Pub. L. 110-85.
2 Contains Nonbinding Recommendations
Draft Not for Implementation
74 MDRs for class I and those class II devices that are not permanently implantable, life supporting, 
75 or life sustainingother than any type of class I or II device that FDA has, by notice, published 
76 in the Federal Register or by letter to the person who is the manufacturer or importer of the 
77 device, indicated should be subject to part 803 in order to protect the public healthin 
78 accordance with criteria established by FDA. The criteriarequire those reports to be in summary 
79 form and made on a quarterly basis. See section 519(a)(1)(B)(ii)of the FD&C Act. In the Federal 
80 Register of March 8, 2011 (76 FR 12743), FDA explained that, pending further notice from the 
81 Agency, all class I devices and those class II devices that are not permanently implantable, life 
82 supporting, or life sustaining would remain subject to individual reporting requirements under 
83 Part 803 to protect the public health, pursuant to section 519(a)(1)(B)(i)(III) of the FD&C Act. 
84 Consequently, unless granted an exemption, variance, or alternative, manufacturers of those 
85 devices have continued to be required to submit individual malfunction reports under Part 803. 
86 FDA began a pilot program in 2015 for the submission of MDRs of certain malfunctions in a 
87 summary format on a quarterly basis (80 FR 500105).
88
89 In the MDUFA IVCommitment Letter, FDA committed to streamliningMDR requirementsfor
90 malfunction reporting.6 To help meet the MDUFA IV commitment, FDA issued a notification in 
91  2017 (82 FR 609227) outlining FDAs proposal to grant an alternative under 21 CFR 803.19 to 
92  permit manufacturer reporting of certain device malfunctions in summary format on a quarterly 
93  basis, subject to certain conditions, and requested public comment. FDA granted that alternative 
94  in 2018 to manufacturers of devices in certain product codes and provided notice of an order 
95  granting that alternative in the Federal Register (Final VMSR notice, 83 FR 409738). 
96   
97  The FDA implemented the VMSR Program only after the Agency had conducted the 2015 pilot 
98  program that demonstrated the value of the program to public health, better use of Agency 
99  resources, and promotion of public transparency.  
100   
101 As explained when it proposed the VMSR Program (82 FR 609229),and consistent with our 
102 VMSR Program experience to date, FDA believes that bundling like events together into a 
103 single summary report description has benefits for manufacturers, FDA, and the public. For 
104 many manufacturers, we expect this approach will greatly reduce the volume of reports that the 
105 manufacturerneeds to submit to FDA. As moreinformation is received in a streamlined manner, 
106 it canfacilitate a more efficient understanding by FDA of malfunction issues. For the public, 
107 summary reports may make malfunction event trends for a particular device more readily 
108 transparent. We believe increased manufacturer participation in the program will enhance these 
109 benefits.
110
5 Available at https://www.federalregister.gov/d/2015-20309.
6 See 163 CONG. REC. S4729-S4736 (daily ed. August 2, 2017) (Food and Drug Administration User Fee 
Reauthorization), also available at https://www.fda.gov/media/102699/download.
7 Available at https://www.federalregister.gov/d/2017-27650.
8 Available at https://www.federalregister.gov/d/2018-17770.
9 Available at https://www.federalregister.gov/d/2017-27650. 
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III.  Principles of Voluntary Malfunction Summary 
111
Reporting
112
113 In the Final VMSR notice, FDA identified the following overarching principles for summary 
114 reporting of malfunctions under the VMSR Program:
115
116 1. The collection of information in summary format should allow FDA to collect sufficient 
117 detail to understand reportable malfunction events.
118
119 2. To increase efficiency, summary malfunction reporting should occur in a common format 
120 for the electronic reporting system used.
121
122 3. Information about reportable malfunctions should be transparent to FDA and to the 
123 public, regardless of whether the information is reported as an individual MDR or a 
124 summary report.10 Information contained in a summary malfunction report that is 
125 protected from public disclosure under applicable disclosure laws is redacted prior to 
126 release of the report.
127
128  4. Manufacturers should communicate information regarding an imminent hazard11 at the 
129 earliest time possible.
130
131  5.  Summary reporting is meant to streamline the process of reporting malfunctions. It does 
132  not change regulatory requirements for MDR-related investigations or recordkeeping by 
133  manufacturers. For example, manufacturers participating in the VMSR Program remain 
134  subject to requirements for establishing and maintaining MDR event files under 21 CFR 
135  803.18. In addition, under the Quality System regulation, manufacturers must evaluate, 
136  review, and investigate any complaint that represents an MDR reportable event (see 21 
137 CFR 820.198).
138
139  6.  Summary reporting information should not be duplicative of information received 
140 through other MDR reporting processes.
141
IV.  Voluntary Malfunction Summary Reporting Program 
142 
Eligibility and Scope
143
10 Consistent with this principle, summary reports submitted by manufacturers under the VMSR Program are made 
available to the public in the Manufacturer and User Facility Device Experience (MAUDE) database.The MAUDE 
database is available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm. For more 
information about FDAs procedures for disclosing information submitted under 21 CFR Part 803, see 21 CFR 
803.9.
11 For the purposes of this overarching principle and consistent with FDAs 2018 notice of granting an alternative 
that permits manufacturer reporting of certain device malfunction MDRs in summary form on a quarterly basis, 
(Final VMSR notice, 83 FR 40793), FDA intends imminent hazard to capture situations in which a device poses a 
significant risk to health and creates a public health situation that should be addressed immediately to prevent injury.
4 Contains Nonbinding Recommendations
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144 The VMSR Program permits manufacturers of devices within eligible product codes to report 
145 certain device malfunction MDRs in summary form quarterly, as an alternative to submitting 
146 individual MDRs for reportable malfunction events.Manufacturers may self-elect to 
147 participate in the VMSR Program by submitting summary malfunction reports for eligible 
148 product codes, and do not need to submit a separate application to FDA to participate. 
149 Participation in theVMSR Program is not required, and manufacturers of devices within eligible 
150 product codes may continue submitting individual, 30-day malfunction reports in compliance 
151 with 21 CFR 803.50 and 803.52,if a manufacturer chooses to do so. FDA updates the Agencys 
152 searchable Product Classification Database12 to reflect product codes eligible for participation in 
153 the VMSR Program. 
154
155  The VMSR Program helps enhance the FDAs capacity to effectively monitor the safety and 
156  effectiveness of devices. The VMSR Programs conditions help ensure that manufacturers 
157 submit sufficient information to allow FDAto detect potential safety issues and identify 
158 malfunction trends, while the summary reports provide information on malfunctions in a more 
159 efficient format. The program thus enables FDA to be more effective in its device safety 
160 oversight. The following sub-sections are intended to explain the factors FDA generally 
161 considers when determining if a product code is eligible for the VMSR Program and to clarify 
162 event types that are not covered by the VMSR Program. Further clarification on the reporting 
163 conditions of the Program are discussed under Section V. 
164
A. Product Code Eligibility
165
166 WhenFDA implemented the VMSR Program in 2018, the Agency evaluated all device product
167 codes, for all device classes,to determine Program eligibility, including product codes for 
168  device-led combination products.As noted in FDAs Final VMSR notice, product codes that 
169  have been in existence for fewer than two years generally are not eligible, unless the new product 
170  code was created solely for administrative reasons.13 In FDAs experience, this two-year period 
171  is important for having more timely, detailed information to monitor malfunction events. FDA 
172 continues to evaluate new product codes after they have been in existence for two years to 
173 determine whether it is appropriate for those product codes to be eligible for the VMSR Program. 
174 FDAalso periodically evaluates ineligible product codes for eligibility changes.
(1) Periodic Evaluation
175
176 As stated in section VI of the Final VMSR notice (83 FR 4097314), the FDA intends to
177 periodically assess and update the eligibility of product codes for the VMSR Program. As part 
178 of determining eligibility of product codes,FDA intends to considerthe devices benefit-risk 
179 profile and available postmarket safety information, particularly related to device malfunctions. 
180 The Agency generally considers whether quarterly, summary reporting of device malfunctions, 
181 in accordance with the conditions of the VMSR Program, would allow FDA to timely identify 
12 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm. After searching, the 
field Summary Malfunction Reporting specifies the eligibility status of a particular product code.
13 Final VMSR notice (83 FR 40973).
14 Available at https://www.federalregister.gov/d/2018-17770. 
5 Contains Nonbinding Recommendations
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182 potential new or increased safety concerns for devices within the product code at issue. If FDA 
183 determines that aproduct code is eligible, FDA intends to update the Product Classification 
184 Database15 accordingly.
185
186  In analyzing available postmarket safety information for devices within a certain product code, 
187  the Agency also intends to consider, among other things, the frequency of reported serious 
188 injuries and deaths, the number of 5-day reports,and whether the product code has any class I or
189 II recalls.The Agency may also consider the types of malfunctions that occur in agiven product 
190 code, the complexity of those malfunctions, and the ability for FDA to understand theirroot 
191 cause. FDAmay also consider whether the product code is associated with recent, ongoing, or 
192 potential public health issues that may necessitate the detail and frequency of individual 
193 malfunction reporting for FDA to identify and better characterize new or persistent safety issues. 
194 Whena public health issue necessitates close monitoring of individual adverse events associated 
195 with certain devices, the Agency may determine that summary reporting under the VMSR 
196 Program is not appropriate forproduct codes for those devices. For example, FDA has 
197 determined that certain reusable devices may have a high risk of infection if they are not 
198 adequately reprocessed. Devices listed in Appendix E of the FDA guidance document, 
199 Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,16
200 areexamples of device types associated with such risks, and FDA has determined for these 
201 product codes that summary reporting was not appropriate.
202
203 FDAs eligibility determinations are intended to follow the overarching principles of the VMSR 
204 Program described in Section IIIabove, to help ensurethat summary reporting of malfunctions 
205 for all eligible product codes allows FDA to collect sufficient information to understand the
206 reported events, that information can be provided in a common format and is transparent to FDA 
207 and to the public, that imminent hazards will be communicated at the earliest time possible, and 
208 that summary reporting for devices inany eligible product code streamlines the process of 
209 reporting malfunctions. 
(2) Eligibility Requests
210
211 Manufacturers may send a request under 21 CFR 803.19(b) for a product code or multiple 
212 product codes to be considered for eligibility in the VMSR Program and for manufacturers of 
213 devices within such product code(s)to begranted the same summary reporting alternative for 
214 reportable malfunction events associated with those devices. FDA intends to periodically review 
215 manufacturer requests and update the eligibility of product codes for the VMSR Program based 
216 on requests received.
217
218 For requests emailed to FDA at MDRPolicy@fda.hhs.gov, manufacturers should submit the 
219 following information:
220  The firms name, address, registration number;
221  The contact persons name, telephone number, and email address;
15 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm.
16 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-
health-care-settings-validation-methods-and-labeling.
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222  Complete device identification and description, including product code and review 
223 panel;
224   A complete statement of the request and justification for the request, including a 
225 discussion of known information related to the product codes benefit-risk profile and 
226 postmarket safety, and why individual malfunction reporting is not necessary; and
227   As part of the justification for the request, a manufacturer should provide a copy of 
228 any prior FDA correspondence (including the references to the Document ID #) 
229 regarding device eligibility status and describe any actions taken to address any issues 
230 noted in prior FDA correspondence regarding device eligibility for participation in the 
231 VMSR Program.
B. Event Types and Reporters Not Covered by the VMSR 
232
Program
233
234  As described above, the VMSR Program is generally available for manufacturers of devices 
235  within eligible product codes. However, the following types of MDR reportable events and 
236  entities subject to MDR reporting requirements are outside the scope of the VMSR Program 
237  alternative granted under 21 CFR 803.19: 
238   
239    Reportable death and serious injuries;17 
240   
241    A reportable malfunction is associated with a 5-day report, as required in 21 CFR 
242  803.53; and 
243   
244    Importers and device user facilities, because 21 CFR Part 803 does not require either 
245  entity to report malfunctions to FDA.18 
V.  VMSR Program Conditions 
246 
A.  Individual Reporting Conditions 
247 
248  As previously discussed, manufacturers participating in the VMSR Program submit summary 
249  malfunction reports under an alternative to certain MDR reporting requirements that FDA has 
250 granted to manufacturers of devices within eligible product codes.  When FDA grants such 
251 modifications to the MDR reporting requirements, we may impose other reporting requirements 
252 to ensure the protection of public health (21 CFR 803.19(c)).  Accordingly, as set forth in the 
17 See section IV.A of the Final VMSR notice (83 FR 40973).  The alternative granted under 21 CFR 803.19 to 
manufacturers participating in the VMSR Program does not alter the requirement that reportable deaths and serious 
injuries must be reported to FDA within the mandatory 30-calendar day timeframe, under 21 CFR 803.50 and 
803.52, or within the 5-work day timeframe under 21 CFR 803.53, as applicable. Thus, if a manufacturer 
participating in the VMSR Program becomes aware of information reasonably suggesting that a device that it 
markets may have caused or contributed to a death or serious injury, then the manufacturer must submit an 
individual MDR for that event because it involves a reportable death or serious injury.
18 See section IV of the Final VMSR notice, footnote 1 (83 FR 40973).  Importers are required to report 
malfunctions to the manufacturer under 21 CFR 803.40(b). Unlike manufacturers and importers, device user 
facilities are not required under 21 CFR Part 803 to submit malfunction reports to any entity.
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253 Final VMSR notice (83 FR 4097319), FDA imposed several conditions that manufacturers must 
254 follow if they elect to participate in the VMSR Program under the alternative.20  These include 
255 conditions for individual reporting, submission of supplemental reports, and the format and 
256 submission schedule for summary reports.  We describe and clarify these conditions in the 
257 following subsections.  
258
259 FDA explained in the Final VMSR notice that individual reporting is necessary under certain 
260 circumstancesfordevices within product codes that are otherwise eligible for the VMSR 
261 Program.For certain individual reporting conditions, as described below, manufacturers are 
262 responsible for identifying whether the condition applies. For other individual reporting 
263 conditions, FDA will notify manufacturers that individual reporting is necessary. Such 
264 notifications will explain why FDA determined that individual reporting is necessary and,as 
265 appropriate, the steps necessary for a manufacturer to resume summary, quarterly reporting. 
266
267 Manufacturers participating in the VMSR Program must submit individual reports in the 
268 following circumstances, in accordance with the conditions of the program:
269 (1) Reportable malfunction is associated with a 5-day report
270 Under 21 CFR 803.53(a), amanufacturer must submit a5-day report if it becomes aware of an 
271 MDR reportable eventthat necessitates remedial action to prevent an unreasonable risk of 
272 substantial harm to the public health.  After submitting a 5-day report required under 21 CFR 
273 803.53(a), all subsequent reportable malfunctions of the same nature that involve substantially 
274 similar devices21 must be submitted as individual MDRs pursuant to 21 CFR 803.50 and 803.52,
275 unless FDA notifies the manufacturer that the issue has been resolved to FDAs satisfaction and 
276 individual reports are no longer required.Summary reporting of malfunctions may then resume 
277 on the regularly scheduled summary reporting cycle.22 Submission of reportable malfunctions 
278 associated with 5-day reports in this manner will assist FDA in monitoring the time course and 
279 resolution of the issue presenting an unreasonable risk of substantial harm to the public health.
280 (2) A reportable malfunction is the subject of certain device 
281 recalls
282 As stated in section IV.B.2. of the Final VMSR notice (83 FR 4097323), when a device is the 
283 subject of a recall involving the correction or removal of the device to address a malfunction and 
284 that correction or removal is required to be reported to FDA under 21 CFR Part 806 (this 
285 includes class I and class II recalls, but not class III recalls),24 all reportable malfunction events 
19 Available at https://www.federalregister.gov/d/2018-17770. 
20 Throughout this section, FDA uses the term must to describe conditions of the VMSR Program consistent with 
the Final VMSR Program notice as well as to describe statutory or regulatory requirements.
21 For example, and consistent with the Final VMSR notice, a substantially similar device could be a device that is 
the same except for certain performance characteristics or a device that is the same except for certain cosmetic 
differences in color or shape.  See Final VMSR notice, section II.C (83 FR 40973).  
22 Final VMSR notice, section IV.B (83 FR 40973). 
23 Available at https://www.federalregister.gov/d/2018-17770. 
24 See 21 CFR 7.3(m) for the definition of each numerical recall classification.
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286 of the same nature25 that involve the same device or a similar device marketed by the same 
287 manufacturer must be submitted as individual MDRs in accordance with 21 CFR 803.50 and 
288  803.52 until the date that the recall is terminated by FDA.26 After the recall is terminated, 
289  summary reporting may resume on the regularly scheduled summary reporting cycle, unless after 
290  the recall event, FDA has revoked the VMSR Program alternative with respect to that device 
291 product code. 
292
293  The requirement to submit individual reports under this condition is triggered on the date that the 
294  manufacturer submits a report of a correction or removal required under 21 CFR Part 806 (or the 
295  date that the manufacturer submits a report of the correction or removal under 21 CFR part 803 
296  or 21 CFR part 1004 instead, as permitted under 21 CFR 806.10(f)). This will allow FDA to 
297  monitor the frequency of reportable malfunctions associated with the recall and effectiveness of 
298 the recall strategy.
299
300  If a manufacturer becomes aware of reportable malfunction events before the date that the 
301  requirement to submit individual reports is triggered and a summary report for those events has 
302  not yet been submitted to FDA, then the manufacturer must submit any of those malfunction 
303  events related to the recall in a summary MDR format within 30 calendar days of submitting the 
304  required report of correction or removal. In the summary MDR, the manufacturer should include 
305  a check box of recall in section H.7 (If Remedial Action Initiated, Check Type) of the 
306 electronic Form FDA 3500A.
307  (3)  FDA has determined that individual MDR reporting is 
308 necessary to address a public health issue
309  If FDA determines that individual malfunction reports are necessary to provide additional 
310  information and more rapid reporting for an identified public health issue involving certain 
311  devices, manufacturers must submit reportable malfunction events for those devices as individual 
312  MDRs pursuant to 21 CFR 803.50 and 803.52. Such determination may apply to all reportable 
313  malfunctions for a particular device or multiple devices (e.g., all devices within an eligible 
314  product code); such determination may also apply to only certain types of malfunctions for the 
315 particular device(s), depending on the scope of the public health issue. 
316
317  As stated in the Final VMSR notice, FDA will provide written notification to manufacturers of 
318  relevant devices that individual MDR submissions are necessary. FDA will also provide further 
319  written notice when manufacturers of those devices may resume participation in summary 
320  malfunction reporting.  If a manufacturer becomes aware of reportable malfunction events before 
321  receiving written notice to submit such events individually, and a summary report for those 
322  events has not yet been submitted to FDA, then the manufacturer must submit malfunction 
323  events for the identified devices to FDA within 30 calendar days of receiving notification from 
324 FDA.  
325
25 By malfunction events of the same nature and consistent with the Final VMSR notice, FDA means additional 
reportable malfunction events involving the same malfunction that prompted the recall.
26 See 21 CFR 7.55 (describing when recalls will be terminated).
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326 Below, we have provided examples of situations where FDA has determined that individual 
327 MDR reporting is necessary to address a public health issue, and summary reporting would not 
328 be appropriate. However, public health issues are not uniform, can be unpredictable, and may 
329 arise in various ways; the following are examples, and there may be other scenarios not 
330 described below where individual malfunction reports are necessary to address or evaluate a 
331 public health issue. As illustrated below, this individual reporting condition may apply to
332 reporting for a particular device or multiple devices of the same type,or only to certain types of 
333 malfunctions for that device type.
334
335 Examples of Circumstances in which FDA has Determined Individual Malfunction Reporting is 
336 Necessary: 
337   Where FDA has determined that certain reusable devices that fall within eligible 
338 product codes may have a high risk of infection if they are not adequately reprocessed, 
339 which FDA considers a public health issue. 
340    Where there is an ongoing safety signal or other safety-related investigation of a 
341  known or potential public health concern. 
342    Where root causes of malfunction events are not well understood.  
343  (4)  FDA has determined that a device manufacturer may not 
344  report in summary reporting format 
345  FDA may determine that a specific manufacturer may no longer participate in the VMSR 
346  Program for reasons including, but not limited to, failure to comply with applicable MDR 
347  requirements under 21 CFR Part 803, failure to follow the conditions of the VMSR Program, or 
348  the need to monitor a public health issue such as an investigation into safety-related issues at a 
349  specific manufacturers establishment.27   
350   
351  As we stated in section IV.B.3 of the Final VMSR notice, in these cases, FDA will provide 
352  written notification to the device manufacturer to submit individual malfunction reports in 
353  compliance with 21 CFR 803.50 and 803.52. The requirement to submit individual reports under 
354  this condition is triggered on the date the manufacturer receives the written notification from 
355  FDA. If a manufacturer became aware of reportable malfunction events before the date that the 
356  requirement to submit individual reports is triggered under this condition and a summary report 
357 for those events has not yet been submitted to FDA, then the manufacturer must submit those 
358 malfunction events within 30 calendar days of receiving notification from FDA.28  
359 (5) A new type of reportable malfunction occurs for a device
360 As stated in the Final VMSR notice, if a manufacturer becomes aware of information reasonably 
361 suggesting that a reportable malfunction event has occurred for a device that the manufacturer 
362 markets and the reportable malfunction is a new type of malfunction that the manufacturer has 
363 not previously reported to FDA for that device, then the manufacturer must submit an individual 
364 report for that reportable malfunction in compliance with 21 CFR 803.50 and 803.52. After the 
365 manufacturer submits this initial individual report, subsequent malfunctions of this type may be 
27 Final VMSR notice, section IV.B.4 (83 FR 40973).
28 Final VMSR notice, section IV.B.4 (83 FR 40973).
10 Contains Nonbinding Recommendations
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366 submitted in summary form according to the quarterly reporting schedule described in Section 
367 V.C(2)of this guidance document, unless another individual reporting condition applies.
B.  Supplemental Reports
368
369 Under the VMSR Program, in general, if a manufacturer becomes aware of information required 
370 in a malfunction summary report that the manufacturer did not submit to FDA because the
371 information was not previously known or was not available when the manufacturer submitted the 
372 initial summary malfunction report, then the manufacturer must submit the supplemental 
373 information to FDA in an electronic format in accordance with 21 CFR 803.12(a). As set forth in 
374 the Final VMSR notice(83 FR 4097329),supplemental information must be submitted by 
375  manufacturers to FDA by the submission deadlinedescribed in Table 1Summary Malfunction 
376 Reporting Schedule of the Final VMSR notice,30 which we provide below in Section V.C(2)of 
377 this guidance document.  Supplemental information must be submitted by the applicable 
378 deadlineaccording to the date on which the manufacturer becomes aware of the supplemental 
379 information. Manufacturers must also continue to follow the requirements for the content of 
380 supplemental reports set forth in 21 CFR 803.56, meaning that fora supplemental or follow-up 
381 report,the manufacturer must:
382
383 a. Indicate that the report being submitted is a supplemental or follow-up report;
384 b. Submit the appropriate identification numbers of the report that is being updated with the 
385 supplemental information (i.e., original manufacturer report number on which thereport 
386 was based); and
387 c. Include only the new, changed, or corrected information.
388
389 Ifa manufacturer submits a summary malfunction report and subsequently becomes aware of 
390 information reasonably suggesting that an event (or events)previously submitted in a 
391 malfunction summary report represents a reportable serious injury or death event, or a new type 
392 of reportable malfunction, the manufacturer mustsubmit an initial, individual MDR for the 
393 identified serious injury, death, or new type of reportable malfunction event within 30 calendar 
394 days of becoming aware of the additional information. The manufacturer must also
395 simultaneously submit a supplemental report to update the initial malfunction summary report 
396 and include only the new, changed, or corrected information.
C. Summary Reporting Instructions
397
398 To meet the conditions of the VMSR Program alternative granted under 21 CFR 803.19, 
399 manufacturers of devices in eligible product codes who elect to participate in the VMSR 
400 Program must submit summary malfunction reports in the format described under section IV.D, 
401 Malfunction Reporting Summary Format of the Final VMSR notice, completing the applicable 
402 sections of Form FDA 3500A,31 which must be submitted electronically.  
403
29 Available at https://www.federalregister.gov/d/2018-17770. 
30 Final VMSR notice, section IV.F (83 FR 40973).
31 Available at https://www.fda.gov/medical-devices/postmarket-requirements-devices/mandatory-reporting-
requirements-manufacturers-importers-and-device-user-facilities.
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404 FDA has included an example in Appendix A: Example of Malfunction Summary Reports of this 
405 guidance document. 
406
(1) Instructions using Form FDA 3500A
407
408 Separate summary malfunction reports must be submitted for each unique combination of brand 
409 name, device model, and MDR adverse event code(s).32,33 We note that manufacturers must
410 includethe device identifier (DI)34 portion of the unique device identifier (UDI)in each Form 
411 FDA 3500A, if available. The summary reporting instructions are the same across devices and 
412 device-led combination products.
413
414 Each summary malfunction report must include at least the following information collected on 
415 Form FDA3500A and must be submitted in electronic format. This information should be 
416 placed in the corresponding field of the form, as described in the forms instructions. 
417    Describe Event or Problem  The device event narrative must include a detailed 
418  description of the nature of the events and, if relevant and available, we recommend 
419  including a range of patient age and weight and a breakdown of patient gender, race, 
420  and ethnicity. Inclusion of patient age, weight, gender, race, and ethnicity is not a 
421 required entry for the form; however, FDA recommends including thesedescriptors in 
422 a text narrative if the information is available and indicates that a malfunction is more 
423 likely to affect a specific group of patients.35
424   Brand Name Include the device brand name. 
425    Common Device Name and Product Code  Include the common name of the device 
426  and its product code. 
427    Manufacturer Name, City, and State  Add the manufacturers name and identify its 
428  location. Multiple manufacturing sites could be entered in the form if the device is 
429 manufactured at multiple sites.36
430  Model Numberand other device identifying information Enter the device model 
431 and/or catalog number and lot number(s) and/or serial number(s) for the devices that 
432 are the subject of the MDR. Include any DIportion of the UDI37 for the device version 
433 or model that is the subject of the MDR. If more than one DI is associated with the 
434 summary report and the Device Identification field cannot accommodate all associated 
435 DI information, the additional narrative field may be used to identify all associated 
436 DIs, in addition to the other manufacturer narrative information.
437  Contact Office (and Manufacturing Site(s) for Devices)Enter the name, address, 
438 and email of the manufacturer reporting site (contact office), including the contact 
32 Information on MDR Adverse Event Codes can be found at https://www.fda.gov/medical-devices/mandatory-
reporting-requirements-manufacturers-importers-and-device-user-facilities/mdr-adverse-event-codes 
33 Final VMSR notice, section IV.D (83 FR 40973).
34 The device identifier is a mandatory, fixed portion of a UDI that identifies the specific version or model of a 
device and the labeler of that device. 21 CFR 803.3.
35 See Final VMSR notice (83 FR 40973).
36 Final VMSR notice (83 FR 40973).
37 For class I devices, the universal product code (UPC) may serve as the UDI (21 CFR 801.40(d)). In these 
instances, include the UPC in Section D.4.
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Draft Not for Implementation
439 name for the summary report being submitted. Enter the name and address of the 
440 manufacturing site(s) for the device, if different from the contact office.
441    Phone Number of Contact Office  Add a phone number for the contact office. 
442    Combination Products (if applicable) Check if the report involves a combination 
443  product.  Manufacturers may also enter other applicable information.   
444    Type of Reportable Event  Check Malfunction.  Manufacturers may check 
445  Summary Report boxes and identify the number of events. 
446    Adverse Event Problem  Enter the corresponding codes, including as many codes as 
447  necessary to describe the event problem and evaluation for the reportable malfunction 
448  events that are being summarized: 
449    Medical Device Problem Code 
450    Type of Investigation 
451    Investigation Findings 
452    Investigation Conclusions, even if the device was not evaluated 
453    Additional Manufacturer Narrative  Provide a summary of the results of the 
454  investigation for the reported malfunctions, including any follow up actions taken, and 
455  any additional information that would be helpful in understanding how the 
456  manufacturer addressed the malfunction events summarized in the report. Enter a 
457 breakdown of the malfunction events summarized in the report: the number of devices 
458 that were returned, the number of devices that were labeled for single use (if any), 
459 and the number of devices that were reprocessed and reused (if any).
(2) Reporting Schedule and Logistics
460
461  As stated in section IV.F of the Final VMSR notice(83 FR 4097338), to meet the conditions of 
462  the alternative established under the VMSR Program, manufacturers submitting malfunction 
463 summary reports or supplemental reports to amalfunction summary report must submit those 
464 reports electronically39 on a quarterly basis according to the schedule in Table 1.The summary 
465 malfunction report must include the MDR Number, which consists of the registration number of 
466 the manufacturer, the year in which the event is being reported, and a 5-digit sequence number. 
467 Information included in a malfunction summary report must be current as of the last date of the 
468 quarterly timeframe identified in Table 1.
469
470 All reportable malfunction eventsforeligible product codes may be reported in the summary 
471 format described in SectionV.C(1)of this guidance, unless the events are excludedfrom the 
472 scope of the VMSR Program or subject to one of the individual reporting conditions of the 
473 program (see Sections IV.B-0).  If a manufacturer elects to participate in the VMSR Program, the 
474 summary reports must be submitted to the FDA on a quarterly basis, according to Table 1. 
475
476 Table 1. VMSR ReportingSchedule
38 Available at https://www.federalregister.gov/d/2018-17770. 
39 For more information, see the FDA guidance Questions and Answers about eMDR - Electronic Medical Device 
Reporting, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/questions-and-
answers-about-emdr-electronic-medical-device-reporting-guidance-industry-user.
13 Contains Nonbinding Recommendations
Draft Not for Implementation
Reportable malfunctions that a  Should be submitted to the FDA by
manufacturer become aware of during 
these timeframes
January 1  March 31 April 30
April 1  June 30 July 31
July 1  September 30 October 31
October 1  December 31 January 31
477
478
14 Contains Nonbinding Recommendations
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Appendix A: Example of Malfunction Summary Reports 
479
480 The following hypothetical exampleis solely meant to illustrate how to summarize malfunction 
481 events in summary reports under the VMSR Program. Real-world reporting scenarios will 
482 depend on the particular details of the malfunction(s) in question.Please note that Form FDA 
483 3500A is subject to change over time, and the example provided below is solely meant to 
484 illustrate how the form might be filled out in the scenario described. 
485
Multiple malfunction events with two device problems
486
487 A manufacturer receives 50 malfunction reports within the quarterly timeframe that include two 
488 types of device malfunctions that are related to a specific model (XYZ, Version 2, multiple UDI-
489 DIs) of their AC powered ABC Bed: (1)35 events involve a tear in a disposable cover; and (2) 
490 25 events involve a screw that attaches the bed rail to the mounting bracket on the bed, which 
491 loosens due to vibration. Ten of the events involve both types of device malfunctions. None of 
492 the events involves patients. None of the events necessitates remedial action to prevent an 
493 unreasonable risk of substantial harm to the public health.
494
495 As stated in Section V.C., separate summary malfunction reports must be submitted for each 
496 unique combination of brand name, device model, and MDR adverse event code(s). In this 
497 example, there is one brand of device and one device model. There are three different 
498 combinations of adverse event codes, and therefore, three summary reports should be submitted 
499 to FDA:
500
501 1. Report #1: 25 events that involve torn covers only; 
502 2. Report #2: 15 events that involve loose screws only; and 
503 3. Report #3: 10 events that involve both torn covers and loose screws. 
504
505 Manufacturers should note that the summary reporting format requires firms to identify the 
506 method, result, and conclusion codes in Form FDA 3500A, including as many codes as are 
507 necessary to describe the event problem and evaluation for the reportable malfunction events that 
508 are being summarized. If the report summarizes reportable events that involved more than one 
509 type of device problem, such as the example Report #3 described above, differences in the 
510 conclusion code according to the different device problems can be explained in the narrative 
511 text.40
512
40 Final VMSR notice (83 FR 40973).
15