Contains Nonbinding Recommendations 
 
Draft  Not for Implementation 
 
Remanufacturing of Medical Devices 
Draft Guidance for Industry and 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DRAFT GUIDANCE 
 
This draft guidance document is being distributed for comment purposes 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 June 24, 2021. 
 
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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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. 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 Regulation, 
Policy, and Guidance Staff at RPG@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Draft  Not for Implementation 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 
17048 and complete title of the guidance in your 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. 
 
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Table of Contents
 
 
I.  Introduction .........................................................................................................................1 
II.  Background .........................................................................................................................2 
  FDA activities ...............................................................................................................2 
  FDAs current thinking .................................................................................................3 
III.  Scope ..................................................................................................................................3 
IV.  Definitions ..........................................................................................................................4 
V.  Guiding Principles ...............................................................................................................5 
VI.  Relevant considerations to determine if activities are remanufacturing ................................7 
  What is a significant change to device performance or safety specifications? ................7 
  Determining whether activities are remanufacturing ..................................................8 
A1. Add, remove, or change a component/part/material that directly or indirectly contacts 
body tissue? ....................................................................................................................... 12 
A1.1 Is there a significant change to device performance or safety specifications? ............. 12 
A2. Add or remove component/part/material or change the dimensional or performance 
specifications of a component/part/material? ..................................................................... 13 
A2.1 Is there a significant change to device performance or safety specifications? ............. 14 
A3. Is there a new or modified risk or is there a change in the performance or safety 
specifications? ................................................................................................................... 14 
A3.1 Is there a significant change to device performance or safety specifications? ............. 15 
VII. Changes involving software ............................................................................................... 15 
VIII. Considerations for labeling ................................................................................................ 16 
Appendix A.  Examples .......................................................................................................... 18 
(1)  Component/part/material activities .......................................................................... 18 
(2)  Software activities ................................................................................................... 28 
Appendix B.  Documentation examples .................................................................................. 30 
   
 
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Remanufacturing of Medical Devices 
1 
Draft Guidance for Industry and 
2 
Food and Drug Administration Staff 
3 
4   
5  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
6  Administration (FDA or Agency) on this topic. It does not establish any rights for any person 
7  and is not binding on FDA or the public. You can use an alternative approach if it satisfies the 
8  requirements of the applicable statutes and regulations. To discuss an alternative approach, 
9  contact the FDA staff or Office responsible for this guidance as listed on the title page.  
10   
11  I.  Introduction 
12  Medical devices encompass a vast array of products with different technologies, product 
13  lifecycles, complexity, intended users, and environments of use. Many devices are reusable and 
14  need preventive maintenance and repair during their useful life. For these devices, proper 
15  servicing is critical to their continued safe and effective use. However, there is a lack of clarity 
16  regarding the distinction between servicing and remanufacturing of a device. Most notably, 
17  remanufacturing has implications for the regulatory responsibilities of entities performing these 
18  activities.1 
19   
20  This draft guidance is intended to help clarify whether activities performed on devices are likely 
21  remanufacturing. Such clarification is intended to help provide consistency and better 
22  understanding of applicable statutory and regulatory requirements. This draft guidance also 
23  includes recommendations for information that should be included in labeling to help  
24  assure the continued quality, safety, and effectiveness of devices that are intended to be serviced 
25  over their useful life. In drafting this guidance, FDA considered objective evidence and 
26  information learned from the Agencys activities discussed in this draft guidance.  
27   
28  For the current edition of the FDA-recognized standard(s) referenced in this document, see the 
29  FDA Recognized Consensus Standards Database.2 For more information regarding use of 
30  consensus standards in regulatory submissions, please refer to the FDA guidance titled 
31  Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 
 
1 FDAs Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices (FDA Report on Device 
Servicing) discusses medical device servicing in more detail. Available at 
https://www.fda.gov/media/113431/download.  
2 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. 
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32  Devices3 and Standards Development and the Use of Standards in Regulatory Submissions 
33  Reviewed in the Center for Biologics Evaluation and Research.4 
34   
35  The contents of this document do not have the force and effect of law and are not meant to bind 
36  the public in any way, unless specifically incorporated into a contract. This document is intended 
37  only to provide clarity to the public regarding existing requirements under the law. FDA 
38  guidance documents, including this guidance, should be viewed only as recommendations, unless 
39  specific regulatory or statutory requirements are cited. The use of the word should in Agency 
40  guidance means that something is suggested or recommended, but not required. 
41   
42  II.  Background 
43    FDA activities 
44  FDA has been working to gain additional perspectives on the distinction between servicing 
45  and remanufacturing and has undertaken several efforts to help promote clarity. FDA opened a 
46  docket for public comment5 and held a public workshop in 2016.6 FDA received comments, 
47  complaints, and adverse event reports alleging inadequate servicing, which were discussed and 
48  analyzed in the FDA Report on Device Servicing,7 published by FDA in May 2018 in 
49  accordance with section 710 of the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-
50  52).8  
51   
52  In the FDA Report on Device Servicing, FDA concluded that a majority of the comments, 
53  complaints, and adverse event reports received by the Agency that referred to inadequate 
54  servicing causing or contributing to adverse events and deaths actually pertained to 
55  remanufacturing. This conclusion was based on FDAs evaluation of the available objective 
56  evidence9 related to the quality, safety, and effectiveness of medical device servicing. 
57   
58  In 2018, FDA released a white paper, opened a public docket, and held a public workshop to 
59  facilitate public discussion on the distinction between servicing and remanufacturing.10 The 
 
3 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices. 
4 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/standards-development-
and-use-standards-regulatory-submissions-reviewed-center-biologics-evaluation. 
5 81 FR 11477. Public comments submitted to the docket are searchable under FDA-2016-N-0436, available at 
https://www.regulations.gov/docket?D=FDA-2016-N-0436. 
6 81 FR 46694. 
7 Available at https://www.fda.gov/media/113431/download. 
8 FDAs conclusions in this report were based on the available information, which included but was not limited to 
the information presented at the 2016 public workshop, responses to the docket request for comments, and 
evaluation of objective evidence related to the quality, safety, and effectiveness of medical device servicing. 
9 The objective evidence evaluated in the FDA Report on Device Servicing included a numerical estimation of 
service and repair entities, literature review, ECRI Institute analysis, medical device reports (MDR), and complaints 
that FDA received. 
10 Available at https://wayback.archive-it.org/7993/20201222125933/https://www.fda.gov/medical-
devices/workshops-conferences-medical-devices/public-workshop-medical-device-servicing-and-remanufacturing-
activities-december-10-11-2018-12102018. FDA requested comments through docket number FDA-2018-N-3741. 
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60  white paper described FDAs initial thoughts about guiding principles, provided a flowchart with 
61  accompanying text for understanding the distinctions, and contained a complementary approach 
62  for software, as well as considerations for labeling, and examples utilizing the flowchart. FDA 
63  also included targeted questions throughout the white paper for which the Agency sought 
64  feedback. FDA considered the comments from the public docket and discussions during the 
65  public workshop in developing this draft guidance. 
66   
67    FDAs current thinking 
68  The distinction between remanufacturing and servicing is important to understand. 
69  Remanufacturing is the processing, conditioning, renovating, repackaging, restoring, or any other 
70  act done to a finished device that significantly changes the finished devices performance or 
71  safety specifications, or intended use.11 For the purposes of this guidance, we refer to the original 
72  equipment manufacturers (OEMs) legally marketed finished device as the legally marketed 
73  device.  
74   
75  Servicing is the repair and/or preventive or routine maintenance of one or more parts in a 
76  finished device, after distribution, for purposes of returning it to the safety and performance 
77  specifications established by the OEM and to meet its original intended use.12 As described in 
78  the FDA Report on Device Servicing, FDAs authority to regulate the servicing of medical 
79  devices by any entity is grounded in the Agencys authority to regulate medical devices and 
80  radiation-emitting electronic products under the Federal Food, Drug, and Cosmetic (FD&C) Act.  
81   
82  Irrespective of an entitys self-identified designation as a servicer or remanufacturer, FDA 
83  focuses on the specific activities an entity performs on a particular device.13 The determination 
84  of whether the activities an entity performs are remanufacturing affects the applicability and 
85  enforcement of regulatory requirements under the FD&C Act and its implementing regulations. 
86  FDA has consistently enforced requirements under the FD&C Act and its implementing 
87  regulations on entities engaged in remanufacturing, including but not limited to registration and 
88  listing, adverse event reporting, the Quality System (QS) regulation, and marketing submissions. 
89   
90  III.  Scope 
91  Because of the apparent confusion between servicing and remanufacturing among entities 
92  performing these activities, FDA committed in the FDA Report on Device Servicing to issue 
93  guidance that clarifies the difference between servicing and remanufacturing activities. To assist 
 
11 See 21 CFR 820.3(w). 
12 For purposes of the report that Congress required FDA to post on its website, section 710(c) of FDARA (Pub. L. 
115-52, 131 Stat. 1068) defines servicing to include, with respect to a device, refurbishing, reconditioning, 
rebuilding, remarketing, repairing, remanufacturing, or other servicing of the device. However, for purposes other 
than this report, FDA does not consider remanufacturing to be a type of servicing.  
13 The designations of servicer and remanufacturer are not mutually exclusive. The same entity may meet the 
definition of either designation based on their activities on one or multiple devices. 
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94  with this clarification, FDA focuses this draft guidance on those activities that are likely 
95  remanufacturing. 
96   
97  This draft guidance addresses activities performed on devices that are intended to be reused and 
98  maintained. This draft guidance discusses whether activities performed by OEMs and third 
99  parties on such devices are likely remanufacturing. This draft guidance is not intended to adopt 
100  significant policy changes, but to clarify FDAs current thinking on applicable definitions, and 
101  clarify, not change, the regulatory requirements applicable to remanufacturers. The concepts in 
102  this draft guidance are also not intended to alter or supersede existing regulations and policies 
103  related to the regulatory threshold for submitting a marketing submission for a device. 
104   
105  The products included within the scope of this guidance are devices as defined in section 201(h) 
106  of the FD&C Act, including software and electronic products that meet the definition of a device. 
107  In general, the concepts discussed in this guidance are meant to apply to all reusable devices, 
108  irrespective of their classification into class I, II, or III, including those subject to premarket 
109  approval. This guidance is not intended to address reprocessed single-use devices. 
110   
111  IV.  Definitions  
112  The following definitions apply for the purposes of this guidance.14  
113    Manufacturers (Manufacturers, OEMs, or Remanufacturers): A manufacturer is any 
114  person who designs, manufactures, fabricates, assembles, or processes a finished 
115  device.15 A remanufacturer is any person who processes, conditions, renovates, 
116  repackages, restores, or does any other act to a finished device that significantly 
117  changes the finished devices performance or safety specifications, or intended use.16 
118  Remanufacturers are considered to be manufacturers.17 For electronic products, a 
119  manufacturer is any person engaged in the business of manufacturing, assembling, or 
120  importing electronic products.18 
121    Intended use: The general purpose of the device or its function, which encompasses 
122  the indications for use.19 
123    Performance specifications: The performance characteristics of a device established 
124  by the OEM for the device to perform as intended, including those listed in device 
125  labeling or in finished product release specifications. Some examples include 
126  measurement accuracy, output accuracy, energy output level, and stability criteria. 
127    Recondition/Refurbish/Rebuild: Restores a medical device to the OEMs original 
128  specifications or to be like new. The device may be brought to current 
129  specifications if the change(s) made to the device do not significantly change the 
130  finished devices performance or safety specifications, or intended use. These 
 
14 Consistent with FDAs current thinking in this context, some of the definitions that appeared in the FDA Report 
on Device Servicing have been modified to reflect updated understanding and practice. 
15 21 CFR 820.3(o). 
16 21 CFR 820.3(w). 
17 21 CFR 820.3(o) and 820.3(w). 
18 21 CFR 1000.3(n). 
19 FDA uses this term consistent with the meaning of intended uses in 21 CFR 801.4. 
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131  activities include repair of components, installation of OEM provided updates and 
132  upgrades, and replacement of worn parts. 
133    Remanufacture: Process, condition, renovate, repackage, restore, or any other act 
134  done to a finished device that significantly changes the finished devices performance 
135  or safety specifications, or intended use.20  
136    Repair: A type of servicing that returns a component to original specifications, 
137  including replacing non-working components or parts outside of routine or periodic 
138  upkeep for the current owner of the device.  
139    Reprocessing: With respect to reusable devices, means validated processes used to 
140  render a medical device, which has been previously used or contaminated, fit for a 
141  subsequent single use on a patient. These processes are designed to remove soil and 
142  contaminants by cleaning and to inactivate microorganisms by disinfection or 
143  sterilization. 21 
144    Safety specifications: The safety characteristics of a device established by the OEM 
145  for the safe use of the device, including those incorporated into the device design and 
146  finished product release specifications, generally including the devices compensating 
147  controls and risk mitigations. Some examples include alarms, sensors, and locking or 
148  fail-safe mechanisms. 
149    Service: Repair and/or preventive or routine maintenance of one or more parts in a 
150  finished device, after distribution, for purposes of returning it to the safety and 
151  performance specifications established by the OEM and to meet its original intended 
152  use. Servicing excludes activities that significantly change the finished devices 
153  safety or performance specifications, or intended use.  
154    Third party servicers and Independent Service Organizations (ISOs): Entities, other 
155  than the OEM or healthcare delivery organizations, that maintain, restore, refurbish, 
156  or repair a finished device after distribution, for purposes of returning it to the safety 
157  and performance specifications established by the OEM and to meet its original 
158  intended use. 
159   
160  V.  Guiding Principles 
161  In using this guidance to help determine whether activities are remanufacturing, FDA 
162  recommends application of the following guiding principles: 
163   
164  1.  Assess whether there is a change to the intended use  Given that the purpose of 
165  servicing is to return the device to the safety and performance specifications established 
166  by the OEM and to meet its original intended use, any change to the intended use should 
 
20 21 CFR 820.3(w). 
21 See the FDA guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and 
Labeling, available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-
medical-devices-health-care-settings-validation-methods-and-labeling. 
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167  be evaluated to determine whether the activity is remanufacturing.22 
168   
169  2.  Determine whether the activities, individually and cumulatively, significantly 
170  change the safety or performance specifications of a finished device  Under 21 CFR 
171  820.3(w), remanufacturing includes activities that significantly change the performance 
172  or safety specifications of the finished device. FDA considers change to also include 
173  activities that improve the device. Activities that are not intended to significantly change 
174  the performance or safety specifications, however, should still be evaluated to determine 
175  whether they do significantly change the finished devices performance and safety 
176  specifications. Multiple changes, when considered cumulatively, may significantly 
177  change the performance or safety specifications of the legally marketed device and 
178  should be evaluated. 
179   
180  3.  Evaluate whether any changes to a device require a new marketing submission  
181  Regardless of whether changes made to a legally marketed device are remanufacturing, 
182  such changes should be evaluated to determine whether a premarket notification (510(k)) 
183  or other marketing submission is required pursuant to the FD&C Act and applicable 
184  regulations, and entities should consult relevant guidance for FDAs recommendations on 
185  the topic.23 For example, a change to a device subject to 510(k) and/or special controls 
186  should be considered with respect to the criteria in 21 CFR 807.81 describing when a new 
187  510(k) submission is required and any special controls under the relevant device 
188  classification regulation, respectively. 
189   
190  4.  Assess component/part/material24 dimensional and performance specifications  
191  Assessment of changes to dimensional and performance specifications can inform 
192  whether the activity performed is remanufacturing. The impact of 
193  component/part/material changes can be evaluated by comparison to the OEM 
194  components/parts/materials specifications and/or through verification and validation 
195  testing. Deviations in component/part/material specifications from the OEMs legally 
196  marketed device may result in significant changes to the devices performance or safety 
197  specifications, and may necessitate closer evaluation (such as conducting testing or a 
198  risk-based assessment) and consideration of the regulatory criteria describing when a new 
199  marketing submission is required.  
200   
 
22 Consistent with Guiding Principle 3, any changes that affect or change intended use should be considered 
pursuant to applicable regulations. 
23 See, e.g., Deciding When to Submit a 510(k) for a Change to an Existing Device, available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-
existing-device, and Deciding When to Submit a 510(k) for a Software Change to an Existing Device, available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-software-
change-existing-device, for FDAs current thinking on this topic. 
24 21 CFR 820.3(c) defines a component as any raw material, substance, piece, part, software, firmware, labeling, or 
assembly which is intended to be included as part of the finished, packaged, and labeled device. In this guidance, 
component and component/part/material are used interchangeably. Due to the nature of software and firmware, 
consideration of whether activities involving them may be remanufacturing is discussed separately from 
components/parts/materials.  
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201  5.  Employ a risk-based approach  Entities should employ a risk-based approach, such as 
202  one that conforms to or is consistent with ISO 14971: Medical devices  Application of 
203  risk management to medical devices when assessing whether an activity they perform is 
204  remanufacturing. For the purposes of this guidance, a risk-based assessment is based on 
205  the combination of multiple risk concepts that are important for managing the risks of 
206  medical devices. Risk estimation, risk acceptability, risk control, benefit/risk analysis, 
207  assessment of hazards and hazardous situations, and overall risk evaluation are all 
208  concepts that can be applied during these activities. The concept of risk, as defined in 
209  ISO 14971, is the combination of the probability of occurrence of harm and the severity 
210  of that harm. Although the risk terminology used in this document is primarily derived 
211  from ISO 14971, we recognize that an individual entitys terminology may differ.  
212   
213  For the purposes of this guidance, a new risk is a new hazard or hazardous situation that 
214  did not exist for the legally marketed device. An activity performed on a device may 
215  introduce a new risk, or may modify the probability or severity of a known risk. An 
216  activity is likely remanufacturing when a risk-based assessment identifies any new risks 
217  or significant modifications to known risks, as these are likely to significantly change 
218  performance or safety specifications, in comparison to the legally marketed device. 
219   
220  6.  Adequately document decision-making  When deciding whether an activity is 
221  remanufacturing or not, FDA recommends that the rationale for the determination be 
222  documented in sufficient detail, including reference to supporting verification and 
223  validation data, to explain how the determination was made. Specifically, such 
224  documentation should specify why the activities performed on the device do or do not 
225  significantly change the performance or safety specifications, or intended use of the 
226  legally marketed device. If an entity previously determined that an activity was not 
227  remanufacturing, and the same entity is performing the identical activity on the same 
228  version or model of a device, such documentation could reference previous 
229  determinations. Effective documentation can facilitate sound decision-making and 
230  evaluation of relevant factors and information such as adverse events, and provide 
231  important information for an entity to help justify their decision-making in the event that 
232  an inspection is conducted by FDA or this information is otherwise requested. 
233   
234  VI.  Relevant considerations to determine if activities are 
remanufacturing 
235 
236    What is a significant change to device performance or 
237  safety specifications? 
238  Remanufacturing is the processing, conditioning, renovating, repackaging, restoring, or any other 
239  act done to a finished device that significantly changes the finished devices performance or 
240  safety specifications, or intended use.25 For purposes of this draft guidance, FDA generally 
 
25 21 CFR 820.3(w). 
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241  considers a significant change to device performance or safety specifications to be one that, 
242  based on verification and validation testing and/or a risk-based assessment, results in a finished 
243  device that is outside the OEMs performance or safety specifications or introduces new risks or 
244  significantly modifies existing risks. For example, a change to a material that contacts the human 
245  body and impacts the adequacy of the OEMs validated reprocessing instructions is likely a 
246  significant change to device performance or safety specifications, and therefore, is likely 
247  remanufacturing. Conversely, replacing an internal capacitor with one that has the same 
248  specifications (e.g., same capacitance, working voltage, temperature range, and footprint) is not 
249  likely to significantly change device performance or safety specifications and therefore, is likely 
250  not remanufacturing. 
251   
252  FDA has identified certain types of activities that, in general, the Agency believes significantly 
253  change the legally marketed devices performance or safety specifications: 
254    Changes to the devices sterilization methods;  
255    Changes to the devices reprocessing instructions;26 and 
256    Changes to the devices control mechanism,27 operating principle,28 or energy type.29  
257   
258  As discussed below in Section VI.B, activities that result in these changes are likely 
259  remanufacturing, and evaluation using the flowchart and accompanying text is not 
260  recommended. 
261   
262  Remanufacturing also includes significant changes to a devices intended use (e.g., changing a 
263  single-use device to become reusable, changing the anatomical location of use).30 Therefore, as 
264  discussed in Guiding Principle 1, any change to the intended use should be evaluated to 
265  determine whether the activity is remanufacturing. 
266   
267    Determining whether activities are remanufacturing 
268  For activities involving components/parts/materials, FDA recommends the use of the flowchart 
269  in this section (Figure 1) to help entities determine if their activities are likely remanufacturing. 
270  Although the servicing and remanufacturing definitions and guiding principles in this document 
271  apply to software, the approach described in this section should not be applied to software due to 
 
26 See the FDA guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and 
Labeling, available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-
medical-devices-health-care-settings-validation-methods-and-labeling.  
27 For purposes of this guidance, a control mechanism is the manner by which the actions of a device are directed. 
One example of a control mechanism change would be a change from analog to digital control of a medical device. 
28 For purposes of this guidance, an operating principle is the mode of operation or mechanism of action through 
which a device fulfills (or achieves) its intended use. An example of a new operating principle would be changing 
the image reconstruction algorithm used in a computed tomography x-ray system from simple back projection to a 
new, more radiation-efficient method. 
29 For purposes of this guidance, energy type is the type of power input to or output from the device. These changes 
include both energy output and input changes. A change from emitting microwave energy to radiofrequency (RF) 
energy would be an example of an energy output change; this type of change would likely be part of a significant 
redesign. 
30 21 CFR 820.3(w). 
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272  its nature and the methods used to evaluate changes to software. Instead, see Section VII for a 
273  discussion of changes involving software. 
274   
275  Figure 1 is a visual aid intended to be used in conjunction with the accompanying text in this 
276  section and guiding principles. Figure 1 and the accompanying text in this section are intended to 
277  address the most common and important considerations that should be evaluated, but is not 
278  meant to capture all potential considerations that an entity should evaluate to determine if their 
279  activities are likely remanufacturing. Rather, they are intended to guide entities in determining 
280  when they should further evaluate such activities by conducting testing or a risk-based 
281  assessment. Figure 1 and the accompanying text are intended to be consulted after it is 
282  determined that there is no significant change to intended use. 
283   
284  In Figure 1, each change (e.g., physical change or change to safety control) should first be 
285  assessed individually to determine whether the activity is likely remanufacturing. After 
286  evaluating each change individually, the cumulative effects should be assessed to determine 
287  whether the activities resulting in the collective changes are likely remanufacturing. The legally 
288  marketed device should be used as the basis for comparison for individual changes and the 
289  cumulative effects of such changes. When there are no deviations in component/part/material 
290  dimensional or performance specifications, or intended use, from the OEM counterpart, and 
291  there are no new or modified risks or change in the performance or safety specifications of the 
292  legally marketed device, there would likely be no significant changes to the legally marketed 
293  device, in the absence of other changes. 
294   
295  FDA does not recommend evaluation with Figure 1 when an activity is performed on behalf of, 
296  or otherwise explicitly authorized by, the OEM and the activity returns the legally marketed 
297  device to its original performance and safety specifications, and intended use. FDA believes such 
298  activities would likely not be remanufacturing, and the determination should be adequately 
299  documented. 
300   
301  Entities performing activities on devices should make a determination about whether each 
302  activity and the cumulative effects of such activities are remanufacturing and document their 
303  rationale.31 When deciding whether an activity is remanufacturing, entities should document the 
304  decision-making process and the basis for the determination. The documentation should be 
305  prepared in a way that an FDA investigator or other third party can understand what the change 
306  was and the rationale underlying the conclusion. For this, we recommend that the documentation 
307  include, at a minimum, the following:32 
308    Product name (including model number and serial number, if applicable); 
309    Date of activities performed, assessment, and determination; 
310    Description of device; 
 
31 In addition, FDA notes that under 21 CFR Part 820, manufacturers are required to maintain certain records as 
applicable, e.g., service reports.  
32 Consistent with Guiding Principle 6, if the identical activity was previously determined to not be remanufacturing, 
is being performed by the same entity, and is being performed on the same version or model of a device, such 
documentation could reference previous determinations. 
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311    Description of activities to be performed, including documentation of 
312  components/parts/materials involved; 
313    Determination of whether the activity is remanufacturing (we recommend using the 
314  applicable sections of this guidance); 
315    Reference to related documents supporting the decision-making process; and 
316    Signature(s). 
317   
318  FDA has included examples of such documentation in Appendix B. 
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Reminder, this flowchart is: 
  Intended to be used after an 
A1
A1.1  entity determines that there is 
Add, remove, or 
Is there a significant  no significant change to 
change a component/part/
Yes change to device  Yes intended use or the devices 
material that directly or 
performance or safety  sterilization methods, 
indirectly contacts 
specifications? reprocessing instructions, 
body tissue?
control mechanism, operating 
principle, or energy type.
  Provided as a visual aid, but 
No does not capture all relevant 
No
considerations. Refer to the 
accompanying text in this 
A2  section when using the 
Add or  flowchart.
A2.1 
remove component/
Is there a significant 
part/material or change the 
Yes change to device  Yes
dimensional or performance 
performance or safety 
specifications of a 
specifications?
component/part/
material?
No
No
A3 
Is there a new or  A3.1
modified risk or is  Is there a significant 
there a change in the  Yes change to device  Yes
performance or safety  performance or safety 
specifications? specifications?
No
Likely Not Remanufacturing No Likely Remanufacturing
319  Figure 1. Flowchart to help determine whether activities performed are likely remanufacturing.   
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320  A1. Add, remove, or change a component/part/material that directly or 
321  indirectly contacts body tissue?  
322  Consistent with FDAs guidance documents on reprocessing33 and biocompatibility,34 
323  respectively, entities should assess how their activities may affect validated reprocessing 
324  instructions or cause an unacceptable adverse biological response resulting from device contact 
325  with the human body, including both patient and healthcare provider tissue.  
326   
327  Direct contact is when a component/part/material comes into physical contact with body tissue, 
328  such as catheter tubing used on a patient. A component/part/material has indirect contact when a 
329  fluid or gas passes through it prior to the fluid or gas coming into physical contact with body 
330  tissue (i.e., the device or component/part/material itself does not physically contact body tissue). 
331  For example, materials in a catheter hub (the part of the catheter that is external to the patient) 
332  indirectly contact the patient when fluids or drugs are infused through the hub and into the 
333  patient. Both direct and indirect contact with the patient or user of the device should be 
334  considered when answering A1. 
335   
336  If there is any addition, removal, or change to a component/part/material on the finished device, 
337  and that component/part/material directly or indirectly contacts body tissue, the answer to A1 
338  should be yes. This includes exposing a previously unexposed component/part/material to 
339  direct or indirect contact with body tissue. Additionally, if there is any change in material type, 
340  formulation, or chemical composition for a component/part/material that directly or indirectly 
341  contacts body tissue, the answer to A1 should be yes. If the entity is uncertain how to respond 
342  to A1, the answer should be yes. A yes answer to A1 does not necessarily mean that the 
343  activity is remanufacturing. Rather, when an entity makes such changes, it should analyze the 
344  impact of the change on the devices performance and safety specifications using the text in 
345  A1.1. 
346   
347  If no component/part/material added, removed, or changed directly or indirectly contacts body 
348  tissue, the answer should be no and then proceed to A2.  
349  A1.1 Is there a significant change to device performance or safety 
350  specifications? 
351  If the activity adds, removes, or changes a component/part/material that directly or indirectly 
352  contacts body tissue (as mentioned above, this includes an activity that exposes a previously 
353  unexposed component/part/material to body tissue either directly or indirectly), a risk-based 
354  assessment should be conducted. The assessment should be conducted to determine whether 
355  there is a significant change to the biocompatibility or the validated reprocessing instructions of 
 
33 See the FDA guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and 
Labeling, available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-
medical-devices-health-care-settings-validation-methods-and-labeling. 
34 See the FDA guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices  
Part 1: Evaluation and testing within a risk management process, available at: https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-
devices-part-1-evaluation-and. 
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356  the legally marketed device. An activity that results in such change may be considered 
357  remanufacturing. 
358   
359  Depending on the magnitude of the change and the nature of the component/part/material, 
360  reprocessing validation and a comprehensive biocompatibility risk assessment or testing may be 
361  necessary. Entities should incorporate factors that affect the reprocessing and biocompatibility of 
362  a device in their risk-based assessment and testing where appropriate. These factors may include 
363  the materials of construction, the processing of the materials, methods (including the sterilization 
364  process), any residuals from aids used during the process, and intended use life of the legally 
365  marketed device. Activities that impact the adequacy of the legally marketed devices validated 
366  reprocessing instructions are likely remanufacturing. 
367   
368  If the answer to A1.1 is yes, then the activity would likely be remanufacturing. If the answer to 
369  A1.1 is no, then proceed to A2. 
370  A2. Add or remove component/part/material or change the dimensional or 
371  performance specifications of a component/part/material? 
372  Add or remove component/part/material? If there is any addition of a component/part/material to 
373  a legally marketed device that was not originally part of the legally marketed device, the answer 
374  to A2 should be yes. Examples include adding an adhesive to mend a break in the device or 
375  fasteners to secure a component/part/material. If there is any removal of a 
376  component/part/material to a legally marketed device that is not replaced in the legally marketed 
377  device, the answer to A2 should be yes. Examples include removing a fastener or barrier 
378  without replacement. Add or remove component/part/material also includes replacing an OEM 
379  component/part/material with the same OEM component/part/material or a non-OEM 
380  component/part/material.35 
381   
382  Change the dimensional or performance specifications of a component/part/material? If there is 
383  any change to or replacement of a component/part/material of the legally marketed device, which 
384  affects the component/part/materials dimensional or performance specifications, the answer to 
385  A2 should be yes.  
386   
387  If a component/part/material is not being added or removed, or the dimensional or performance 
388  specifications of a component/part/material are not being changed, the answer to A2 should be 
389  no. If uncertain, the answer to A2 should be yes. 
390   
391  A yes answer to A2 does not necessarily mean that the activity is remanufacturing. Rather, 
392  when an entity makes such changes, it should analyze the impact of the change on the devices 
393  performance and safety specifications using the text in A2.1. If the answer to A2 is no, then 
394  proceed to A3. 
 
35 As discussed above in Section VI.B., FDA does not recommend evaluation with Figure 1 when an activity is 
performed on behalf of, or otherwise explicitly authorized by, the OEM and the activity returns the legally marketed 
device to its original performance and safety specifications, and intended use. FDA believes such activities would 
likely not be remanufacturing, and the determination should be adequately documented. 
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395  A2.1 Is there a significant change to device performance or safety 
396  specifications? 
397  Does the added or removed component/part/material significantly change the device 
398  performance or safety specifications? When evaluating whether the addition or removal of a 
399  component/part/material significantly changes the devices performance or safety specifications, 
400  the entity should consider the intended use life of the legally marketed device. For instance, 
401  many reusable devices are reprocessed numerous times within their intended use life. Applicable 
402  considerations should include an assessment of whether the added component will withstand 
403  repeated reprocessing cycles within the devices intended use life or whether the removed 
404  component exposes previously unexposed components that will withstand repeated reprocessing 
405  cycles within the devices intended use life. Such an assessment can include verification and 
406  validation testing or a risk-based assessment describing why such testing is not warranted. If the 
407  reusable device will not be able to withstand repeated reprocessing cycles within its intended use 
408  life, the addition or removal of the component/part/material may significantly change the legally 
409  marketed devices performance or safety specifications.  
410   
411  Do the changed dimensional specifications of the component/part/material significantly change 
412  the device performance or safety specifications? In determining whether an activity is 
413  remanufacturing for these types of changes, the entity should consider not only the magnitude of 
414  the dimensional specification change, but the criticality of the modified dimension. The entity 
415  should consider whether dimensional specifications meet a minimum or maximum specification 
416  (e.g., outer diameter cannot exceed 3.0 mm) or are within a range of acceptable tolerance 
417  specifications. If dimensional specifications are within the acceptable range, the answer to A2.1 
418  would likely be no; however, for changes that are outside the acceptable range of dimensional 
419  specifications, the answer to A2.1 would likely be yes. 
420   
421  Do the changed performance specifications of the component/part/material significantly change 
422  the device performance or safety specifications? When evaluating if there is a significant change 
423  to performance or safety specifications, the entity should consider whether performance outputs 
424  meet a minimum and/or maximum specification (e.g., temperature within chamber cannot exceed 
425  25 oC and pressure cannot be less than 150 kPa) or are within a range of acceptable tolerance 
426  specifications (e.g., pump flowrate must be between 2 and 20 mL/hour). If performance 
427  specifications are within the acceptable range, the answer to A2.1 would likely be no; 
428  however, for changes that result in performance specifications that are outside the acceptable 
429  range, the answer to A2.1 would likely be yes.  
430   
431  If the answer to A2.1 is yes, then the change would likely be remanufacturing. If the answer to 
432  A2.1 is no, then proceed to A3. 
433  A3. Is there a new or modified risk or is there a change in the performance or 
434  safety specifications? 
435  The entity should perform a risk-based assessment to identify new or modified risks or a change 
436  in the performance or safety specifications of the legally marketed device based on the activity 
437  being performed on the device. Both the individual change and cumulative changes performed 
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438  on the legally marketed device should be considered. While individual changes may not 
439  significantly change the legally marketed devices performance or safety specifications, the 
440  cumulative changes may do so. The extent of the assessment should be appropriate considering 
441  the nature and extent of the activities being performed. 
442   
443  Is there a new or modified risk? A risk-based assessment can identify whether there are new 
444  risks or modified existing risks in comparison to the legally marketed device. If a new risk is 
445  created or an existing risk has been modified based on the activity being performed, the answer 
446  to A3 should be yes, and this activity should be evaluated using the text in A3.1. If uncertain, 
447  the answer to A3 should be yes. 
448   
449  Is there a change in the performance or safety specifications? A risk-based assessment can also 
450  identify whether there is a change in performance or safety specifications. This assessment 
451  should consider, for example, how a change could impact a devices continued conformity to a 
452  voluntary consensus standard or compliance with a regulation, such as special controls identified 
453  in a device classification regulation. This assessment should also consider whether activities that 
454  break a seal or barrier can adequately return the device to its legally marketed performance and 
455  safety specifications. If a change to performance or safety specifications has been identified, the 
456  answer to A3 should be yes. If uncertain, the answer to A3 should be yes. 
457   
458  When an entity makes a change that has a yes answer to A3, the entity should analyze the 
459  impact of the change on the devices performance and safety specifications using the text in 
460  A3.1. If the answer to A3 is no, then the change is likely not remanufacturing. 
461  A3.1 Is there a significant change to device performance or safety 
462  specifications?  
463  If new or modified risks were identified, the entity should evaluate whether they significantly 
464  change the legally marketed devices performance or safety specifications using the output of the 
465  risk-based assessment performed in A3. Altering or bypassing a safety feature (e.g., fuses, alerts, 
466  alarms, interlocks) likely significantly changes the legally marketed devices performance or 
467  safety specifications. Changes that impact compliance with a regulation or alter conformity with 
468  a voluntary consensus standard would likely significantly change the legally marketed devices 
469  performance or safety specifications and may also adulterate and/or misbrand the device.36  
470   
471  If the answer to A3.1 is yes, then the change would likely be remanufacturing. If the answer to 
472  A3.1 is no, then the change is likely not remanufacturing. 
473   
474  VII. Changes involving software 
475  As described in Section VI, Figure 1 and its accompanying text should not be applied to changes 
476  involving software. Many software changes are likely remanufacturing because of their impact 
477  on a products software architecture, software requirements specifications, unresolved anomalies, 
 
36 See, e.g., sections 501(e)(2) and 502(o) of the FD&C Act. 
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478  and other key characteristics. Further, because the probability of a software failure cannot be 
479  determined using traditional statistical methods, the risk-based assessment approach that FDA 
480  recommends in Section VI should not be applied to software changes. Instead, FDA has 
481  identified certain activities performed on software that are likely not remanufacturing because 
482  they generally do not significantly change the performance or safety specifications of the device: 
483    Activities performed on behalf of or otherwise explicitly authorized by the OEM that 
484  return the legally marketed device to its performance and safety specifications, and 
485  intended use;  
486    Implementing OEM provided updates and upgrades; 
487    Running software-based hardware diagnostics; 
488    Assessing for viruses, malware, and other cybersecurity related issues; 
489    Reinstalling OEM software to restore original performance and safety specifications; 
490    Reverting software to a previous configuration; 
491    Installing cybersecurity updates that are authorized by the OEM; 
492    Turning on or off connectivity features (e.g., Wi-Fi and Bluetooth connections) consistent 
493  with OEM intended use; 
494    Performing data backup and recovery operations; 
495    Assessing software inventory; 
496    Collecting system logs; 
497    Managing user accounts; and 
498    Accessing diagnostic and repair information. 
499   
500  Other activities involving changes to software are likely to significantly change a devices 
501  performance or safety specifications, such that the activity is likely remanufacturing. However, if 
502  an entity believes that an activity involving a change to software does not significantly change a 
503  devices performance or safety specifications, the entity should adequately document its 
504  decision-making (see Guiding Principle 6). Any activity involving software changes that 
505  significantly modifies a devices intended use would be remanufacturing.37 
506   
507  Entities should also consider the unintended consequences and cumulative effects of any 
508  software change(s). Entities performing activities on devices should make a determination about 
509  whether each activity and the cumulative effects of the changes resulting from the activities are 
510  remanufacturing and document their rationale. 
511   
512  VIII.  Considerations for labeling 
513  Based on publicly available information and FDAs activities discussed in Section II.A of this 
514  draft guidance, FDA believes that OEMs of reusable devices intend for their devices to routinely 
515  undergo both preventive maintenance and repair. It is important that such devices include 
516  instructions on how to adequately return a device to its performance and safety specifications 
 
37 See 21 CFR 820.3(w). 
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517  established by the OEM.38 Unintentional remanufacturing can occur when entities do not have 
518  the instructions necessary to return a device to its original performance and safety specifications. 
519  The lack of adequate servicing instructions can also create challenges in the availability of 
520  quality, safe, and effective devices.  
521   
522  Consistent with promoting and protecting the public health, FDA encourages OEMs, as an 
523  industry best practice, to provide servicing instructions that facilitate routine maintenance and 
524  repair of their reusable devices.39 FDA recommends that the labeling of reusable devices include 
525  the following information, as applicable, to facilitate routine device maintenance and repair: 
526    A description of the key performance and safety specifications; 
527    Critical technical or functional specifications, including: 
528    Physical dimensions; 
o
529    Electrical characteristics, including batteries (e.g., chemistry, amperage, voltage, 
o
530  rechargeability), internal fuses, and power supply (e.g., voltage, amperage, 
531  frequency); and 
532    Device-specific performance specifications (e.g., flow rate accuracy or range, 
o
533  humidity, temperature, wavelength). 
534    The recommended maintenance activities and schedule; 
535    Recommended routine testing and acceptance criteria to confirm that the device 
536  remains within its performance and safety specifications; 
537    A description of error codes, alerts, and alarm features on the device; 
538    Precautions and warnings relevant to servicing the device; and 
539    Version number and release date of software.   
 
38 Section 502(f)(1) of the FD&C Act requires that labeling bear adequate directions for use. For non-prescription 
devices, adequate directions for use include instructions on preparing a device for use. 21 CFR 801.5(g). 
Prescription devices are exempt from the adequate directions for use requirement provided certain conditions are 
met, including that the labeling bear information for use, including indications, effects, routes, methods, and 
frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions 
under which practitioners licensed by law to administer the device can use the device safely and for the purpose for 
which it is intended... 21 CFR 801.109(c).  
39 FDAs recommendations in this guidance are not intended to encourage the disclosure of trade secrets or 
confidential commercial information (CCI).  
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540  Appendix A.  Examples 
541  The following are illustrative examples of activities that may be performed on devices with 
542  explanations about why such examples are or are not likely remanufacturing. Note that these 
543  generalized examples do not necessarily account for every possible detail, risk, or consideration 
544  that a manufacturer should evaluate, and should not be taken to mean that the changes described 
545  are or are not definitively remanufacturing. Real-world decisions will depend on the specific 
546  facts and circumstances, including the specific details of the changes made to the specific device. 
547   
548  (1)  Component/part/material activities 
549  Example E.1   
550  Activity: The door of an infusion pump was bent and now pinches the administration set. 
551  The flow rate accuracy fell outside the OEMs specified accuracy range. The door is replaced 
552  with a non-OEM door that is marketed as compatible with this infusion pump. It has the 
553  same overall dimensions and is made from a similar material of construction. However, the 
554  replacement door material is more rigid than the original door.  
555   
556  Relevant questions: 
557  A1. Add, remove, or change a component/part/material that directly or indirectly contacts 
558  body tissue? 
559  No. The existing and replacement doors do not have direct or indirect contact with the 
560  patients body tissue. 
561   
562  A2. Add or remove component/part/material or change the dimensional or performance 
563  specifications of a component/part/material? 
564  Yes, the old door was removed and replaced. While the new door is marketed as compatible, 
565  all dimensions were confirmed through comparative measurement, including the hinges and 
566  latch. The specific material of the original door is unknown and there is a noticeable 
567  difference in flexibility that may impact the pumps performance specifications.  
568   
569  A2.1 Is there a significant change to device performance or safety specifications? 
570  No. Once replaced, the door was confirmed to open and close with similar effort as the 
571  original door and it was confirmed that the added rigidity did not significantly change the 
572  pumps performance or safety specifications (e.g., flowrate accuracy). 
573   
574  A3. Is there a new or modified risk or is there a change in the performance or safety 
575  specifications? 
576  No. A risk-based assessment determined that there are no new or modified risks and there is 
577  no change in performance or safety specifications (e.g., the change does not alter conformity 
578  to a voluntary consensus standard or compliance with a regulation). 
579   
580  Decision: Not Remanufacturing. 
581   
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582  Example E.2   
583  Activity: The rotor within a peristaltic infusion pump no longer functions as intended and is 
584  replaced. The subject pump rotor is no longer supported by the OEM, but a comparable off-
585  the-shelf rotor is available. The dimensions of the rotor, including the individual rollers, are 
586  the same; however, the material of construction of the rollers, which contact and apply 
587  pressure to the administration set, appears to be stainless steel. This is different from the 
588  plastic rollers in the legally marketed device.  
589   
590  Relevant questions: 
591  A1. Add, remove, or change a component/part/material that directly or indirectly contacts 
592  body tissue? 
593  No. Neither the existing or replacement component directly or indirectly contact body tissue. 
594  It is only in contact with the outside of the administration set. 
595   
596  A2. Add or remove component/part/material or change the dimensional or performance 
597  specifications of a component/part/material? 
598  Yes. The rotor was removed and replaced. Also, although the dimensional specifications of 
599  the non-OEM pump rotor, including the individual rollers, are the same as the OEM rotor, 
600  the roller materials are different.  
601   
602  A2.1 Is there a significant change to device performance or safety specifications? 
603  Yes. Once the rotor was replaced, the device appears to function adequately. The change in 
604  material of the rollers does not significantly change the accuracy of the flowrate across the 
605  labeled flowrate range. However, a risk-based assessment identified that the change in 
606  material of the rollers can affect the useful life of the administration set. The change in the 
607  roller material from plastic to stainless steel increases the administration set wear and/or 
608  breakage due to fatigue. Evaluation of this risk concluded that the increased fatigue on the 
609  administration set is more likely to lead to patient under-dosing before the administration set 
610  is intended to be replaced. This significantly changes the devices performance and safety 
611  specifications. 
612   
613  Decision: Remanufacturing. 
614   
615  Example E.3   
616    Activity: The gradient coil of a magnetic resonance (MR) system was damaged during an 
617  imaging session and needs to be replaced. The gradient coil is replaced with a non-OEM 
618  gradient coil. The maximum slew rate of the coil matches that of the OEM gradient coil; 
619  however, the peak gradient strength is larger than the OEM coil. 
620   
621  Relevant questions: 
622  A1. Add, remove, or change a component/part/material that directly or indirectly 
623  contacts body tissue? 
624  No. The gradient coil does not have direct or indirect contact with body tissue. 
625   
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626  A2. Add or remove component/part/material or change the dimensional or performance 
627  specifications of a component/part/material? 
628  Yes. The gradient coil was removed and replaced, and the new gradient coil has a larger 
629  peak gradient strength. 
630   
631  A2.1 Is there a significant change to device performance or safety specifications? 
632  Yes. An assessment was performed to determine the significance of the change. A 
633  gradient coil with a larger peak gradient strength significantly changes the imaging 
634  performance specifications (e.g., slice thickness, spatial resolution).  
635   
636  Decision: Remanufacturing. 
637   
638    Activity: The gradient coil of an MR system was damaged during an imaging session and 
639  needs to be replaced. It is replaced with a non-OEM gradient coil that has different 
640  dimensional specifications and coil design.  
641   
642  Relevant questions: 
643  In this example, the answers to flowchart questions A1 and A2 are the same as Example 
644  E.3.a. except that for A2, the new gradient coil has different dimensional specifications 
645  and coil design. 
646   
647  A2.1 Is there a significant change to device performance or safety specifications? 
648  No. The new gradient coil only differs by small changes in design and dimensional 
649  specifications. There are no significant changes to the performance and safety 
650  specifications (e.g., slew rate, peak gradient strength, power). 
651   
652  A3. Is there a new or modified risk or is there a change in the performance or safety 
653  specifications? 
654  No. A risk-based assessment identified no new or modified risks or change in the 
655  performance or safety specifications due to this change because the non-OEM gradient 
656  coil has the same hardware performance specifications (e.g., slew rate), equivalent 
657  imaging performance, and meets the same safety and performance specifications (e.g., 
658  acoustic output) when compared to the OEM gradient coil.  
659   
660  Decision: Not Remanufacturing.  
661   
662  Example E.4   
663  Activity: The slide heater pads on an immunohistochemistry (IHC) autostainer are worn out 
664  and need to be replaced. They are replaced with an OEM part. 
665   
666  Relevant questions: 
667  A1. Add, remove, or change a component/part/material that directly or indirectly contacts 
668  body tissue? 
669  No. The slide heater pads do not have direct or indirect contact with body tissue. 
670   
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671  A2. Add or remove component/part/material or change the dimensional or performance 
672  specifications of a component/part/material? 
673  Yes. The heater pad components were physically removed and replaced with new pads.  
674   
675  A2.1 Is there a significant change to device performance or safety specifications? 
676  No. An assessment was performed to evaluate this replacement and identified no changes to 
677  dimensions, materials, or performance or safety specifications of the pads. 
678   
679  A3. Is there a new or modified risk or is there a change in the performance or safety 
680  specifications? 
681  No. A risk-based assessment identified no new or modified risks because the slide heater 
682  pads are identical to the original part from the OEM. The device now functions within its 
683  functional specifications identified in the labeling. There is no change in the performance or 
684  safety specifications. 
685   
686  Decision: Not Remanufacturing.  
687   
688  Example E.5   
689  Activity: The tubing on a sample processor became kinked from use and needs to be 
690  replaced. Tubing was found from the same OEM but the tubing is intended for use with a 
691  different sample processor. 
692   
693  Relevant questions: 
694  A1. Add, remove, or change a component/part/material that directly or indirectly contacts 
695  body tissue? 
696  No. There is no direct or indirect contact between the tubing and body tissue. 
697   
698  A2. Add or remove component/part/material or change the dimensional or performance 
699  specifications of a component/part/material? 
700  Yes. The tubing was removed and replaced with new tubing of a different inner diameter.  
701   
702  A2.1 Is there a significant change to device performance or safety specifications? 
703  Yes. The inner diameter of the tubing is different from the legally marketed device. 
704  Verification and validation testing was performed to evaluate this replacement and identified 
705  significant changes to performance because different fluid characteristics (e.g., flow rate) 
706  than those specified for the legally marketed device were noted with the new tubing. 
707   
708  Decision: Remanufacturing.  
709   
710  Example E.6   
711  Activity: A tissue pre-treatment water bath was updated by replacing the heating chamber 
712  with one that has a different temperature range. 
713   
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714  Relevant questions: 
715  A1. Add, remove, or change a component/part/material that directly or indirectly contacts 
716  body tissue? 
717  No. The tissue specimens have been removed from the human body, are within a sealed 
718  container, and neither the water bath nor heating chamber directly or indirectly contacts the 
719  tissue. 
720   
721  A2 Add or remove component/part/material or change the dimensional or performance 
722  specifications of a component/part/material?  
723  Yes. The heating chamber was removed and replaced. The heating chambers performance 
724  specifications were changed because the new heating chamber has a different temperature 
725  range. 
726   
727  A2.1 Is there a significant change to device performance or safety specifications? 
728  Yes. The performance is significantly changed because the heating range extends beyond that 
729  of the heating chamber in the legally marketed device. 
730   
731  Decision: Remanufacturing. 
732     
733  Example E.7   
734    Activity: A stainless steel manual drill is intended to be used in the implantation of 
735  orthopedic devices. The drill is intended to be reprocessed and reused for multiple 
736  procedures. The drill was sharpened because it is dull and difficult to use. This is the first 
737  time the drill has been sharpened. 
738   
739  Relevant questions: 
740  A1. Add, remove, or change a component/part/material that directly or indirectly 
741  contacts body tissue? 
742  Yes. Sharpening the drill removes material and exposes a fresh surface that directly 
743  contacts bone. 
744   
745  A1.1 Is there a significant change to device performance or safety specifications? 
746  No. The drill is not coated. The material and structure of the drill that contacts body 
747  tissue is uniform. A risk-based assessment concluded that removal of material due to 
748  sharpening does not significantly change the biocompatibility or reprocessing.  
749   
750  A2. Add or remove component/part/material or change the dimensional or performance 
751  specifications of a component/part/material? 
752  Yes. Sharpening of the drill removes material changing the dimensions of the drill. 
753   
754  A2.1 Is there a significant change to device performance or safety specifications? 
755  No. The drill was returned to its performance and safety specifications because the entity 
756  sharpened the device to its labeled outer diameter and original edge profile angle. 
757   
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758  A3. Is there a new or modified risk or is there a change in the performance or safety 
759  specifications? 
760  Yes. Sharpening the drill may change the size of the resulting pilot drill hole. Changing 
761  the size of the pilot hole can change the fit of the implant or overall purchase in bone 
762  such that the mechanical integrity of the implant is compromised.  
763   
764  A3.1 Is there a significant change to device performance or safety specifications? 
765  No. Based on the facilitys maintenance record, it was determined that this is the first 
766  drill sharpening. The drill produces the same pilot hole size as the legally marketed 
767  device after the sharpening has been completed. There is no significant change to the 
768  devices performance or safety specifications at this time.  
769   
770  Decision: Not Remanufacturing. 
771   
772    Activity: A stainless steel manual drill with a titanium nitride coating is intended to be 
773  used in the implantation of orthopedic devices. The drill is intended to be reprocessed and 
774  reused for multiple procedures. The drill was sharpened because it is dull and difficult to 
775  use. The drill has been sharpened multiple times. 
776   
777  Relevant questions: 
778  A1. Add, remove, or change a component/part/material that directly or indirectly 
779  contacts body tissue? 
780  Yes. Sharpening the drill removes material and exposes a fresh surface that directly 
781  contacts bone. 
782   
783  A1.1 Is there a significant change to device performance or safety specifications? 
784  No. While sharpening the drill exposes the stainless steel surface beneath the coating, 
785  both the surface coating and underlying stainless steel have been subjected to a 
786  biocompatibility assessment. Additionally, a risk-based assessment concluded that 
787  removal of material due to sharpening does not significantly change the biocompatibility 
788  or reprocessing.  
789   
790  A2. Add or remove component/part/material or change the dimensional or performance 
791  specifications of a component/part/material? 
792  Yes. Sharpening of the drill removes material changing the dimensions and cutting 
793  surface of the drill. 
794   
795  A2.1 Is there a significant change to device performance or safety specifications? 
796  Yes. Based on the facilitys maintenance record, it was determined that the drill has been 
797  sharpened multiple times. While the outer diameter of the drill is not significantly 
798  changed from the legally marketed device, the titanium nitride coating is no longer intact 
799  on the cutting surface of the drill, causing inefficient or destructive cutting. This activity 
800  significantly changes the devices performance and safety specifications. 
801   
802  Decision: Remanufacturing. 
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803   
804  Example E.8   
805    Activity: The lens of an endoscope is cracked. The lens is affixed by an epoxy that is not 
806  described in the labeling. The cracked lens was removed and replaced. The epoxy used 
807  was purchased from the OEM and is identical to that used in the legally marketed device. 
808  The replacement lens was not purchased from the OEM. The lens was tested and 
809  demonstrated to have the same optical specifications (e.g., focal length, Abbe number) 
810  and materials as the original lens. 
811   
812  Relevant questions: 
813  A1. Add, remove, or change a component/part/material that directly or indirectly 
814  contacts body tissue? 
815  Yes, both the lens and the epoxy directly contact body tissue. 
816   
817  A1.1 Is there a significant change to device performance or safety specifications? 
818  No. The epoxy is identical to the epoxy used in the legally marketed device. The 
819  replacement lens is the same material as original lens. A risk-based assessment that 
820  considered both the individual and cumulative changes was performed to determine if the 
821  procedure used to replace the lens affects biocompatibility and reprocessing instructions. 
822  A biocompatibility assessment confirmed that there are no new surfaces previously 
823  unexposed to body tissue. A comprehensive reprocessing risk assessment and testing 
824  demonstrated that the validated reprocessing instructions identified in the labeling of the 
825  legally marketed device are not impacted by the replacement parts or the procedure used 
826  to replace the parts. 
827   
828  A2. Add or remove component/part/material or change the dimensional or performance 
829  specifications of a component/part/material? 
830  Yes. The epoxy and lens were replaced. 
831   
832  A2.1 Is there a significant change to device performance or safety specifications? 
833  No. The optical performance testing (e.g., resolution and distortion) and reprocessing risk 
834  assessment and testing indicated there has been no significant change in performance or 
835  safety specifications.  
836   
837  A3. Is there a new or modified risk or is there a change in the performance or safety 
838  specifications? 
839  No. A risk-based assessment was performed that considered both the individual and 
840  cumulative changes that could have affected biocompatibility, reprocessing, and optical 
841  performance. This assessment identified that there are no new or modified risks, and 
842  there is no change in performance or safety specifications.  
843   
844  Decision: Not Remanufacturing. 
845   
846    Activity: The lens of an endoscope is cracked. The lens is affixed by an epoxy that is not 
847  described in the labeling. The cracked lens was removed and replaced. The epoxy used 
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848  was purchased from the OEM and is identical to that used in the legally marketed device. 
849  The replacement lens comes from a different endoscope model from the same OEM; that 
850  model was 510(k)-cleared with improved optical performance (e.g., resolution and 
851  distortion) relative to the original endoscope. The replacement lens has the same material 
852  but different optical specifications (e.g., focal length, Abbe number) from the original. 
853   
854  Relevant questions: 
855  In this example, the answers to flowchart questions A1, A1.1, and A2 are the same as 
856  Example E.8.a. 
857   
858  A2.1 Is there a significant change to device performance or safety specifications? 
859  Yes. The epoxy is identical to that used in the legally marketed device, but the lens has 
860  different optical specifications from the original lens. The endoscope with the 
861  replacement lens has different imaging specifications relative to the legally marketed 
862  device. While the replacement lens is present on another 510(k)-cleared device, it was not 
863  present on the original endoscope and significantly changes the performance 
864  specifications of the original endoscope. 
865   
866  Decision: Remanufacturing. 
867   
868  Example E.9   
869  Activity: An endoscopes connection to the video processor was damaged during use. After 
870  repair, it was observed that the endoscope readily disconnected from the video processor. To 
871  address this problem, an adapter was added to reduce the probability of a disconnection 
872  between the endoscope and video processor. The adapter was found to be capable of 
873  connecting to the video processor; however, it is bulkier than the connector. 
874   
875  Relevant questions: 
876  A1. Add, remove, or change a component/part/material that directly or indirectly contacts 
877  body tissue? 
878  No. The added adapter does not directly or indirectly contact body tissue.  
879   
880  A2. Add or remove component/part/material or change the dimensional or performance 
881  specifications of a component/part/material? 
882  Yes, the adapter has been added to the endoscope. 
883   
884  A2.1 Is there a significant change to device performance or safety specifications? 
885  No. The adapter still allows the endoscope to be connected to the video processor and optical 
886  performance testing demonstrated the same optical performance as the original endoscope. 
887   
888  A3. Is there a new or modified risk or is there a change in the performance or safety 
889  specifications? 
890  Yes. A risk-based assessment was performed to determine the effects of this added 
891  component. Increased risks exist with the added adapter, such as disconnection from the light 
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892  source, and the potential change to the electrical safety and electromagnetic compatibility 
893  (EMC) of the device. 
894   
895  A3.1 Is there a significant change to device performance or safety specifications? 
896  Yes. Disconnection from a light source during a procedure could result in a loss of imaging 
897  and adverse events such as increased procedure time or other patient injuries such as 
898  perforation. Additionally, testing should also be performed for the electrical safety and EMC 
899  of the device. 
900   
901  Decision: Remanufacturing. 
902   
903  Example E.10  
904  Activity: The motor on a powered wheelchair no longer functions and does not propel the 
905  wheelchair as intended. The motor was inspected and it was determined that the motor 
906  should be replaced. Neither the identical motor nor one with similar specifications could be 
907  located. A motor of similar size was inserted with different power and speed specifications.  
908   
909  Relevant questions: 
910  A1. Add, remove, or change a component/part/material that directly or indirectly contacts 
911  body tissue? 
912  No. The motor does not directly or indirectly contact body tissue. 
913   
914  A2. Add or remove component/part/material or change the dimensional or performance 
915  specifications of a component/part/material? 
916  Yes. The original motor was removed and replaced.  
917   
918  A2.1 Is there a significant change to device performance or safety specifications? 
919  Yes. While the motor has the same physical dimensions, the replacement motor has a 
920  different power output and maximum speed than the legally marketed device. This 
921  significantly changes the devices performance specifications because the wheelchair can go 
922  faster than intended. This also significantly changes the devices safety specifications 
923  because the controller and software to operate the wheelchair may no longer be compatible 
924  with the motor. 
925   
926  Decision: Remanufacturing. 
927   
928  Example E.11  
929    Activity: The liquid cooling system responsible for maintaining the temperature of a 
930  transcranial magnetic stimulation (TMS) coil is malfunctioning and causing the system to 
931  overheat. The cooling system was inspected and it was determined that the pump 
932  circulating the liquid coolant stopped functioning. A replacement pump was located and 
933  installed with no additional changes to the device.  
934   
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935  Relevant questions: 
936  A1. Add, remove, or change a component/part/material that directly or indirectly 
937  contacts body tissue? 
938  No. The liquid coolant is maintained in the sealed coolant system and neither the liquid 
939  coolant nor the pump directly or indirectly contacts body tissue.  
940   
941  A2. Add or remove component/part/material or change the dimensional or performance 
942  specifications of a component/part/material? 
943  Yes, the pump was replaced.  
944   
945  A2.1 Is there a significant change to device performance or safety specifications? 
946  No. Both the dimensions and performance specifications of the original pump were 
947  assessed in comparison to the replacement part. The replacement pump has the same 
948  dimensional and performance specifications of the original pump. The overall 
949  performance and safety specifications of the TMS coils were verified by testing to be the 
950  same.  
951   
952  A3. Is there a new or modified risk or is there a change in the performance or safety 
953  specifications? 
954  No. A risk-based assessment identified no new or modified risks because the replacement 
955  pump is equivalent to that used in the OEMs legally marketed device and there is no 
956  change in the device performance or safety specifications. 
957   
958  Decision: Not Remanufacturing. 
959   
960    Activity: The liquid cooling system responsible for maintaining the temperature of a 
961  TMS coil is malfunctioning and causing the system to overheat. The cooling system was 
962  inspected and it was determined that the pump circulating the liquid coolant stopped 
963  functioning. A replacement pump was located with the same size and flow specifications, 
964  but it uses a different coolant liquid. The pump was replaced with one that uses a 
965  different coolant into the cooling system. 
966   
967  Relevant questions: 
968  In this example, the answer to flowchart question A1 is the same as Example E.11.a. 
969   
970  A2. Add or remove component/part/material or change the dimensional or performance 
971  specifications of a component/part/material? 
972  Yes. A replacement pump that uses a different coolant liquid was installed. 
973   
974  A2.1 Is there a significant change to device performance or safety specifications? 
975  Yes. Although the pump has the same dimensional and flow specifications as the original 
976  pump, the new pump uses a different liquid coolant. The new liquid coolant does not 
977  have the same heat capacity as that used in the legally marketed device. Verification and 
978  validation testing was performed and it was determined that there was a significant 
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979  change to cooling effectiveness, which poses a safety hazard when the TMS coil is not 
980  properly cooled. This may burn the patient or cause further device malfunctions. 
981   
982  Decision: Remanufacturing. 
983   
984  Example E.12  
985  Activity: An energy-delivering aesthetic device has multiple compatible handpieces with 
986  specific areas of application. Applicator A can only be used for the chin, while Applicator B 
987  can only be used on the abdomen. An entity cannibalizes Applicator B and uses those parts to 
988  repair Applicator A for use on the chin. 
989  Relevant questions: 
990  A1. Add, remove, or change a component/part/material that directly or indirectly contacts 
991  body tissue? 
992  Yes. The distal end of Applicator B is used to reconstruct Applicator A. It directly contacts 
993  the patient and delivers the energy. 
994   
995  A1.1 Is there a significant change to device performance or safety specifications? 
996  No. The distal end of both applicators has identical materials and the reprocessing 
997  instructions provided by the OEM are the same for both applicators. A risk-based assessment 
998  was performed to determine the effects of implementing these repairs on the biocompatibility 
999  and reprocessing. A biocompatibility assessment and reprocessing risk assessment were used 
1000  to determine that the performance and safety specifications of the device were not 
1001  significantly changed.  
1002   
1003  A2. Add or remove component/part/material or change the dimensional or performance 
1004  specifications of a component/part/material? 
1005  Yes. The distal end of Applicator B has different dimensional specifications compared to 
1006  Applicator A. 
1007   
1008  A2.1. Is there a significant change to device performance or safety specifications? 
1009  Yes. The surface area that contacts the patient has increased by 150%. The increase in 
1010  surface area changes the energy output delivered to the patient, which significantly changes 
1011  both the performance and safety specifications of Applicator A.  
1012   
1013  Decision: Remanufacturing. 
1014   
1015  (2)  Software activities 
1016  Example S.1   
1017  Activity: A specular microscope with a camera is intended for examination of corneal 
1018  endothelium and for measurement of the thickness of the cornea. The software was updated 
1019  to implement an OEM-authorized patch. 
1020   
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1021  Relevant analysis: The installation of this OEM-authorized patch does not significantly 
1022  change the device performance or safety specifications. See Section VII of this draft 
1023  guidance for further discussion of changes involving software. The patch is intended to 
1024  maintain the original specifications. 
1025   
1026  Decision: Not Remanufacturing. 
1027   
1028  Example S.2   
1029  Activity: A device has the capability of real-time remote customer service where the current 
1030  status of the device can be accessed. A capability is added so that the customer service 
1031  technician can access and directly manipulate the device, including changing device settings, 
1032  resetting the device, delivering energy, and positioning the device.  
1033   
1034  Relevant analysis: The capability of the customer service technician to control the device 
1035  introduces new risks (e.g., accidental device reset, unintended device movement) and 
1036  functionality (remote control and access) that significantly changes the finished devices 
1037  performance and safety specifications.  
1038   
1039  Decision: Remanufacturing. 
1040   
1041  Example S.3   
1042  Activity: A device that connects to a facilitys network has software that was designed to run 
1043  the Microsoft Windows operating system (OS). Adjustments are made to allow the device to 
1044  run using a Linux OS. 
1045   
1046  Relevant analysis: This change introduces new risks and may impact mitigations for existing 
1047  risks that significantly change the finished devices performance and safety specifications. 
1048  This is a redesign of the product and includes the addition of integration with both device 
1049  drivers for the target OS as well as specific features of the OS.  
1050   
1051  Decision: Remanufacturing.   
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1052  Appendix B.  Documentation examples 
1053  The examples below are to illustrate one possible approach to documentation; other approaches 
1054  may also be appropriate. Entities are encouraged to use an approach that works for their specific 
1055  purposes, taking into account the considerations discussed above. The first example 
1056  demonstrates a simple change that does not necessitate detailed analysis. The second example 
1057  demonstrates a more complex change for which additional analysis and reference to supporting 
1058  documentation are warranted. These are generalized examples to demonstrate documentation 
1059  principles and do not necessarily account for every possible detail, risk, or consideration. 
1060   
1061  Remanufacturing Assessment 
1062  (Example 1) 
1063   
1064  Product: Pump ABC, Serial# 123-456 
1065   
1066  Date of activities performed: 12/11/2018 
1067   
1068  Date assessment performed: 12/10/2018 
1069   
1070  Description of device: Syringe pump 
1071   
1072  Description of activities performed: Replaced broken door with part #xxx 
1073   
1074  Determination of whether the activity is remanufacturing: While a change to a body 
1075  contacting component, the door used was OEM-provided and is identical to the broken door. 
1076  Because it is a replacement of an identical part, there are no changes to performance or safety 
1077  specifications. This activity is not remanufacturing. 
1078   
1079  Reference to related documents supporting the decision-making process: N/A 
1080   
1081  Technician performing service: xxx 
1082   
1083  Reviewed by: xxx 
1084   
1085  Signature(s): xxx   
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1086  Remanufacturing Assessment 
1087  (Example 2) 
1088   
1089  Product: Endoscope Infinity, Serial #4FR992 
1090   
1091  Date of activities performed: 9/24/2018-9/30/2018 
1092   
1093  Date assessment performed: 9/22/2018 
1094   
1095  Description of device: Flexible endoscope 
1096   
1097  Description of activities performed: Repair device; lens, irrigation channel, and shaft exterior 
1098  replaced. Each change was individually and cumulatively assessed. 
1099   
1100  Determination of whether the activity is remanufacturing: 
1101  Lens Assessment  
1102    Original lens is cracked and needs replacement; OEM lens and epoxy not available for 
1103  purchase; 
1104    Equivalent lens with same performance specifications and dimensions used (see 
1105  biocompatibility assessment (BCA) #EI-001 and Component Comparative Analysis 
1106  Report (CCAR) #EI-002); 
1107    Epoxy used to secure lens is equivalent to OEM epoxy (see BCA #EI-003 and CCAR 
1108  #EI-004); and 
1109    Leak, optics, and field of view were verified to be within OEM specifications. 
1110   
1111  Irrigation Channel Assessment  
1112    Irrigation channel is worn and leaking fluid into the device; 
1113    OEM part available for purchase and used (part #XX44); and 
1114    Irrigation channel installed and checked for leaks and functionality. 
1115   
1116  Shaft Exterior Assessment  
1117    Shaft exterior damaged during repair activities and needs replacement; 
1118    OEM part not available for purchase; and 
1119    Equivalent shaft exterior with same performance specifications and dimensions used (see 
1120  BCA #EI-005 and CCAR #EI-006). 
1121   
1122  Cumulative Change Assessment  
1123    Full device specification list inspected and passed (see Customer Evaluation Report 
1124  #88239 and OEM specification sheet); 
1125    No change in component exposure to reprocessing when following OEM reprocessing 
1126  instructions; 
1127    A risk-based assessment was performed in each CCAR report; modified risks were 
1128  identified with using non-OEM parts but were demonstrated as not significantly changing 
1129  the devices performance or safety specifications, or intended use; and 
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1130    No other change in the risks, or change in the performance or safety specifications, have 
1131  been identified for the cumulative changes made. 
1132   
1133  This activity is not remanufacturing. 
1134   
1135  Reference to related documents supporting the decision-making process:  
1136  1.  BCA #EI-001 
1137  2.  CCAR #EI-002 
1138  3.  BCA #EI-003 
1139  4.  CCAR #EI-004 
1140  5.  BCA #EI-005 
1141  6.  CCAR #EI-006 
1142  7.  Customer Evaluation Report #88239 
1143  8.  Endoscope Infinity Specification Sheet 
1144   
1145  Technician performing service: xxx 
1146   
1147  Reviewed by: xxx 
1148   
1149  Signature(s): xxx 
32