Contains Nonbinding Recommendations
Draft Not for Implementation
Select Updates for the 506J Guidance: 
506J Device List and Additional 
Notifications 
Draft Guidance for Industry and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DRAFT GUIDANCE
This draft guidance document is being distributed for comment purposes 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 November 17, 2023.
You should submit comments and suggestions regarding this draft document within 90 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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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 20852-1740. 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 
CDRHManufacturerShortage@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.
When final, this guidance will update Notifying FDA of a Permanent 
Discontinuance or Interruption in Manufacturing of a Device Under Section 
506J of the FD&C Act, issued November 17, 2023.
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Draft Not for Implementation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 include the document number 
GUI00021003 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Draft Not for Implementation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.  Overview of Select Updates.................................................................................................... 1
II.  Updates to Section III.B. 506J Device List............................................................................. 2
III.  Updates to Section IV. Additional Notifications .................................................................... 4 Contains Nonbinding Recommendations
Draft Not for Implementation
Select Updates for the 506J Guidance: 
1 
506J Device List and Additional 
2 
Notifications 
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 
11  the requirements of the applicable statutes and regulations.  To discuss an alternative 
12  approach, contact the FDA staff or Office responsible for this guidanceas listed on the title 
13  page.  
14   
I.  Overview of Select Updates 
15 
16  The Food and Drug Administration (FDA or Agency) has developed this draft guidance to 
17  propose select updates to the FDA guidance Notifying FDA of a Permanent Discontinuance or 
18  Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act (hereafter 
19  referred to as the 506J Guidance).1 The 506J Guidance remains in effect, in its current form, 
20  until this draft guidance is finalized, at which time Section II. and Section III. of this draft 
21  guidance will supersede the recommendations in Section III.B. and Section IV., respectively, of 
22  the 506J Guidance. FDA intends to incorporate the updates proposed in this draft guidance into 
23  the 506J Guidance as one final guidance document after obtaining and considering public 
24  comment on these proposed select updates. The sections of the existing 506J Guidance that are 
25  unaffected by these proposed updates are not intended to be substantively changed, with the 
26  exception of technical edits for consistency. 
27   
28  On December 29, 2022, the Prepare for and Respond to Existing Viruses, Emerging New 
29  Threats, and Pandemics Act (PREVENT Pandemics Act) was signed into law as part of the 
30  Consolidated Appropriations Act, 2023, Pub. L. No. 117-328 (hereafter referred to as the FY 
31 2023 Omnibus). Section 2514(c) of the FY 2023 Omnibus directed FDA to issue or revise 
32 guidance regarding requirements under section 506J of the Federal Food, Drug, and Cosmetic 
1Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/notifying-fda-
permanent-discontinuance-or-interruption-manufacturing-device-under-section-506j-
fdc#:~:text=Section%20506J%20of%20the%20FD%26C%20Act%20requires%20manufacturers%20to%20notify,s
upply%20of%20that%20device%20in
1 Contains Nonbinding Recommendations
Draft Not for Implementation
33  Act (FD&C Act) and include a list of each device product code for which a manufacturer of 
34  such device is required to notify FDA in accordance with section 506J. This draft guidance 
35  proposes revisions to the 506J Guidance to meet the requirements under section 2514(c) of the 
36  FY 2023 Omnibus. Additionally, section 2514 of the FY 2023 Omnibus amended section 506J to 
37  add subsection (h), Additional Notifications and directed FDA to issue guidance to facilitate 
38  voluntary notifications. Consistent with section 506J(h), FDA is proposing to update the 506J 
39  Guidance to clarify for stakeholders that FDA may receive voluntary notifications regarding 
40  supply chain issues at any time, unrelated to the declaration or potential declaration of a public 
41  health emergency (PHE).  
42   
43  In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
44  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
45  as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
46  the word should in Agency guidances means that something is suggested or recommended, but 
47  not required. 
48   
II.  Updates to Section III.B. 506J Device List 
49 
50  FDA is proposing to replace Section III.B. of the 506J Guidance with the following language in 
51  this Section II. 
52   
53  Section 2514(c) of the FY 2023 Omnibus directs FDA to issue guidance on the requirements 
54  under section 506J of the FD&C Act and to include a list of each device product code for which 
55  a manufacturer of such device is required to notify the Secretary in accordance with section 
56  506J2 (hereafter referred to as the 506J Device List). Thus, manufacturers of a device on the 
57  506J Device List must notify FDA in accordance with section 506J for each such device. 
58   
59  In response to Executive Order 14001, A Sustainable Public Health Supply Chain, signed on 
60  January 21, 2021, FDA has led an interagency effort (including FDA, Centers for Medicare and 
61  Medicaid Services, Centers for Disease Control and Prevention, Administration for Strategic 
62  Preparedness and Response, United States Department of Veterans Affairs) in collaboration with 
63  healthcare providers and industry representatives within the device ecosystem, to develop a 
64  critical medical device list (CMDL). This list, when completed, will include devices critical for 
65  supporting and sustaining life. 
66   
67  Leveraging the information and perspectives shared during the collaborative efforts to develop 
68  the CMDL, as well as other sources of information and lessons learned during previous PHEs 
69  and other events that have led to shortages of critical medical devices, FDA has developed a list 
70  of devices, by FDA product code, according to the criteria set forth in section 506J(a). When 
71 finalized, this will serve as the list for which a manufacturer of such devices is required to notify 
72 FDA in accordance with section 506J.The 506J Device List is based on the requirements under 
73 section 506J(a), as discussed in Section III.A.of the 506J Guidance. 
74
2See section 2514(c) of the FY 2023 Omnibus.
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75  FDAs website3 hosts the proposed 506J Device List. FDA expects that the list will evolve over 
76  time and FDA intends to periodically reevaluate the list. Any revisions to the 506J Device List 
77  will follow FDAs good guidance practices.4 
78   
79  Manufacturers of devices that FDA has identified on this 506J Device List are required to submit 
80  506J notifications to FDA when the statutory conditions are met (see Section III.C. of the 506J 
81  Guidance for more information on when to notify FDA).5  
82   
83  (1)  Devices FDA has determined are critical to public health 
84  during a public health emergency under Section 506J(a)(1)  
85  The 506J Device List contains those devices FDA has determined are critical to public health 
86  during a public health emergency within the meaning of section 506J(a)(1). In determining 
87  whether a device is critical to public health during a PHE, FDA considers a number of factors. 
88  For various reasons,6 and consistent with the language of section 506J, FDA considers whether a 
89  device is critical to public health during any PHE.7 However, FDA also considers whether there 
90  are certain devices that may be critical to specific PHEs.8 For example, FDAs consideration of 
91  whether a device is critical to a PHE includes, but is not limited to, the following: 
92   
93    Whether the device is used to diagnose, treat, monitor, or prevent a serious disease or 
94  medical condition; and if the device is life-supporting, life-sustaining or intended for use 
95  in emergency medical care or during surgery (section 506J(a)(1)). 
96   
97    Whether the lack of availability of the device is reasonably likely to cause serious injury 
98  or death to patients, healthcare workers, or others if it is not available and there are no 
99  suitable alternatives. 
100   
101  These considerations, coupled with FDAs experience in responding to previous supply chain 
102  disruptions and shortages and the subsequent continued implementation of section 506J has 
103  informed the development of the 506J Device List. The categories set forth in this list reflect, at 
104  this time, the device product codes that FDA has determined are critical to public health during a 
105 PHE, and for which manufacturers should notify FDA, as appropriate. However, if FDA learns 
106 new information, consistent with the factors summarized above, FDA intends to reevaluate the 
107 device types that are critical to public health during a PHE and update the 506J Device List 
108 accordingly.   
109
3See FDAs website on 506J Device List, available at https://www.fda.gov/medical-devices/medical-device-
supply-chain-and-shortages/506j-device-list
4See 21 CFR 10.115(g)(4).
5See section 506J(a).
6For example, multiple PHEs may exist at one time.
7Some devices, such as personal protective equipment devices, may be critical to public health during any PHE.
8Specific PHEs may have certain devices that are critical to that specific PHE. For example, diagnostic tests may be 
critical to a specific PHE.
3 Contains Nonbinding Recommendations
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110  (2) Devices FDA has determined additional information is 
111  needed under Section 506J(a)(2) 
112  During or in advance of a PHE, FDA may also identify, under section 506J(a)(2), devices or 
113  device types for which we have determined that information on potential meaningful supply 
114  disruptions is needed. In making such determination, FDAs considerations may include, but 
115  not be limited to devices that are specific to a type of illness or event (e.g., respiratory illness; 
116  traumatic burns and/or wounds resulting from a disaster).    
117   
118  If FDA determines there are devices or device types for which information on potential 
119  meaningful supply disruptions is needed during a specific PHE, FDA intends to add such devices 
120  or device types to the 506J Device List to assist manufacturers in determining whether they must 
121  submit a 506J notification to FDA.  
122   
III.  Updates to Section IV. Additional Notifications 
123 
124  FDA is proposing to replace Section IV. of the 506J Guidance with the following language in 
125  this Section III. 
126   
127  Section 2514 of the FY 2023 Omnibus amended section 506J of the FD&C Act to add subsection 
128  (h), Additional Notifications. Section 506J(h) clarifies for stakeholders that FDA may receive 
129  voluntary notifications pertaining to the permanent discontinuance or interruption in the 
130  manufacture of a device at any time, unrelated to the declaration or potential declaration of a 
131  PHE.  
132   
133  Under section 506J(h), manufacturers of devices that are life-supporting, life-sustaining, or 
134  intended for use in emergency medical care or during surgery, or any other device the Secretary 
135  determines to be critical to the public health may submit voluntary, additional notifications to 
136  FDA pertaining to a permanent discontinuance in the manufacture of the device (except for any 
137  discontinuance as a result of an approved modification of the device) or an interruption in the 
138  manufacture of the device that is likely to lead to a meaningful disruption in the supply of that 
139  device in the United States, and the reasons for such discontinuance or interruption. FDAs 
140  interpretation of who should submit notifications using section 506J(h) is consistent with our 
141  interpretation in Section III.A. of the 506J Guidance. 
142   
143  For purposes of this guidance, FDA interprets section 506J(h) to clarify that FDA may receive 
144  additional notifications about medical devices at any time, unrelated to the declaration or 
145  potential declaration of a PHE. FDA has always accepted voluntary submissions of information 
146  across many topics, including device supply chain matters. Section 506J(h) does not alter FDAs 
147  ability or authority to receive voluntary information on supply chain or other matters. For 
148  example, early in the COVID-19 pandemic, prior to the enactment of section 506J, FDA 
149 solicited and received voluntarily information from manufacturersof critical devices regarding 
150 supply chain disruptions and manufacturing capacity. During the COVID-19 pandemic, FDA 
151 also received notifications regarding manufacturing interruptions and permanentdiscontinuances 
152 ofa wide range of devices, not all of which were critical to public health. FDA further solicited 
4 Contains Nonbinding Recommendations
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153  and received  voluntary information from manufacturers that were not experiencing 
154  interruptions in manufacturing. This information is imperative to FDAs ability to help prevent 
155  and mitigate shortages. As such, any time a manufacturer of any device is experiencing a 
156  permanent discontinuance or interruption in the manufacture of a device, the manufacturer is 
157  encouraged to submit a notification to FDA. For example, if manufacturers are experiencing any 
158  of the following circumstances, we recommend they submit a 506J notification to the FDA: 
159   
160    Unplanned manufacturing challenges (e.g., labor shortages, delays in raw material 
161  supply, temporary plant closures, packaging or sterilization concerns, or other unforeseen 
162  circumstances that prevent the manufacturer from meeting demand); 
163    Unplanned distribution challenges (e.g., shipping/transportation delays, export/import 
164  challenges, procurement issues); 
165    Increased or projected increased demand unable to be met by the manufacturer (e.g., 
166 backorder, allocation, low fulfillment rates); 
167   Potential broader/connected interruptions (e.g., reliance on critical suppliers who are 
168  experiencing supply chain interruptions); and 
169    Actions or circumstances affecting software-enabled devices that may disrupt healthcare 
170  operations (e.g., device cybersecurity vulnerabilities or exploits).  
171   
172  FDA encourages submission of these additional voluntary notifications to FDA within 7 calendar 
173  days after an interruption in manufacturing occurs, or no later than 7 calendar days after the 
174  manufacturer decides to permanently discontinue the device, as applicable. Section III.C. of the 
175  506J Guidance provides more information about when to submit notifications to FDA. For these 
176  additional notifications, we recommend that manufacturers provide updates to the initial 506J 
177  notification when there is a change in status to help ensure that FDA is acting on the most current 
178  information. 
179   
180  Section III.D. of the 506J Guidance provides more information about what information to 
181  include in 506J notifications. 506J notifications may include both information required by 
182  section 506J (see Section III.D.1. of the 506J Guidance) and additional information to help 
183  inform FDAs supply chain analysis (see Section III.D.2. of the 506J Guidance). Section III.E. of 
184  the 506J Guidance provides more information about how to submit notifications. Section III.D. 
185 of the 506J Guidance provides more information about how the Agency uses information from 
186 notifications, including actions FDA may take to help mitigate or prevent a shortage resulting 
187 from adiscontinuance or interruption in the manufacture of a device for which a notification is 
188 received. 
5