Contains Nonbinding Recommendations 
The Least Burdensome Provisions: 
Concept and Principles 
Guidance for Industry and  
Food and Drug Administration Staff  
 
 
Document issued on February 5, 2019. 
 
The draft of this document was issued on December 15, 2017. 
This document supersedes The Least Burdensome Provisions of the FDA 
Modernization Act of 1997: Concept and Principles, issued on October 4, 
2002. 
 
For questions about this document regarding CDRH-regulated devices, contact the Office of the 
Center Director at (301) 796-6900. For questions about this document regarding CBER-regulated 
devices, contact the Office of Communication, Outreach and Development in CBER 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  
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Preface 
Public Comment 
You may submit electronic comments and suggestions at any time for Agency consideration 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 FDA-2017-D-6702. Comments may not be acted 
upon by the Agency until the document is next revised or updated. 
Additional Copies 
CDRH 
Additional copies are available from the Internet. You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document 
number 1332 to identify the guidance you are requesting. 
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., 
WO71, Room 3128, Silver Spring, MD 20903, 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/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformati
on/Guidances/default.htm. 
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Table of Contents
 
I.  Introduction ...........................................................................................................................................................4
II.  Background ...........................................................................................................................................................5
III.  Scope.....................................................................................................................................................................7
IV.  Guiding Principles................................................................................................................................................8
V.  Applications of Least Burdensome Principles......................................................................................................9
A.  The minimum information necessary...................................................................................................................9
(1)  Less burdensome sources of clinical data .................................................................................................. 10
(2)  Use of nonclinical data ............................................................................................................................... 12
(3)  Acceptance of alternative approaches ........................................................................................................ 13
B.  The most efficient means .................................................................................................................................... 14
(1)  Reducing the burden of traditional clinical studies .................................................................................... 14
(2)  Use of benefit-risk assessments .................................................................................................................. 16
(3)  Streamlining processes and reducing administrative burden ..................................................................... 17
(4)  Smart regulation ......................................................................................................................................... 19
(5)  Global harmonization ................................................................................................................................. 20
C.  The right time ................................................................................................................................................. 21
(1)  Balancing premarket and postmarket information needs ........................................................................... 21
(2)  Just-in-time testing ..................................................................................................................................... 22
VI.  Compliance Policies that Support the Goals of the Least Burdensome Concept ................................................ 23
VII.  Conclusion .......................................................................................................................................................... 24
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The Least Burdensome Provisions: 
Concept and Principles 
 
Guidance for Industry and  
Food and Drug Administration Staff  
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page.  
I.  Introduction 
The Food and Drug Administration (FDA) is committed to helping patients gain more timely 
access to new medical devices and to maintaining continued access to existing medical devices 
that are high quality, safe and effective, by expediting their development, assessment, review, 
and surveillance, consistent with the Agencys statutory mission to protect and promote the 
public health.1 By streamlining regulatory processes and removing or reducing unnecessary 
burdens associated with FDA regulatory activities, patients can have earlier and continued access 
to beneficial products. 
Since the Food and Drug Administration Modernization Act of 1997 (FDAMA), Congress has 
directed FDA to take a least burdensome approach to medical device premarket evaluation in a 
manner that eliminates unnecessary burdens that may delay the marketing of beneficial new 
products, while maintaining the statutory requirements for clearance and approval. This guidance 
is intended to accurately reflect Congress intent by describing the guiding principles and 
recommended approach for FDA staff and industry to facilitate consistent application of least 
burdensome principles. 
We define least burdensome to be the minimum amount of information necessary to 
adequately address a relevant regulatory question or issue through the most efficient 
manner at the right time. This least burdensome definition considers the type of information, 
different approaches to generating or providing information, and when during the total product 
lifecycle information should be generated or provided to FDA. This concept applies to all 
                                                           
1 Section 1003 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 
 
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products that meet the statutory definition of a device and throughout the total product lifecycle 
(premarket and postmarket).2 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in Agency guidance means that something is suggested or 
recommended, but not required. Throughout this guidance document, the terms we, us, and our 
refer to FDA staff from the Center for Devices and Radiological Health (CDRH) or the Center 
for Biologics Evaluation and Research (CBER) involved in device regulation.3 
II.  Background 
Congress first added least burdensome provisions to the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) under FDAMA (Public Law 105-115). Congress enacted additional least 
burdensome provisions to the FD&C Act through the FDA Safety and Innovation Act (Public 
Law 112-144) (FDASIA) and the 21st Century Cures Act (Public Law 114-255) (Cures Act). The 
least burdensome statutory provisions currently state: 
  Whenever the Secretary requests information to demonstrate that devices with differing 
technological characteristics are substantially equivalent, the Secretary shall only request 
information that is necessary to making substantial equivalence determinations. In 
making such request, the Secretary shall consider the least burdensome means of 
demonstrating substantial equivalence and request information accordingly.4 
  Any clinical data, including one or more well-controlled investigations, specified in 
writing by the Secretary for demonstrating a reasonable assurance of device effectiveness 
shall be specified as a result of a determination by the Secretary that such data are 
necessary to establish device effectiveness. The Secretary shall consider, in consultation 
with the applicant, the least burdensome appropriate means of evaluating device 
effectiveness that would have a reasonable likelihood of resulting in approval.5 
  In requesting additional information with respect to a premarket approval application 
(PMA), the Secretary shall consider the least burdensome appropriate means necessary 
to demonstrate a reasonable assurance of device safety and effectiveness.6 
  [T]he Secretary shall consider the role of postmarket information in determining the 
least burdensome means of demonstrating a reasonable assurance of device safety and 
                                                           
2 Section 201(h) of the FD&C Act. 
3 This guidance has been prepared by CDRH in consultation with CBER, the Center for Drug Evaluation and 
Research (CDER), and the Office of Combination Products (OCP). 
4 Section 513(i)(1)(D)(i) of the FD&C Act. 
5 Section 513(a)(3)(D)(ii) of the FD&C Act. 
6 Section 515(c)(5)(A) of the FD&C Act.   
 
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effectiveness.7 
  The term necessary in the least burdensome provisions means the minimum required 
information that would support a determination of substantial equivalence or a 
reasonable assurance of device safety and effectiveness.8 
  The least burdensome provisions do not change the standards for premarket approval or 
substantial equivalence.9 
FDA issued least burdensome guidance documents after the enactment of FDAMA. Suggested 
Format for Developing and Responding to Deficiencies in Accordance with the Least 
Burdensome Provisions of FDAMA (Deficiencies Guidance) was issued on November 2, 
2000. In that guidance document, FDA recommended that its staff use a specific format for 
requests for additional information needed to make a decision on a medical device marketing 
submission (often called deficiencies or deficiency letters) to be in accordance with least 
burdensome principles. This format was intended to directly connect FDA requests to applicable 
statutory and regulatory criteria for a decision and optimize the time and effort of both industry 
and FDA. That guidance document also included a recommended format for industry responses 
to FDA deficiencies. 
With the enactment of the Medical Device User Fee Amendments of 2017 (Public Law 115-52, 
 201-210) (MDUFA IV), FDA committed to updating the Deficiencies Guidance. Developing 
and Responding to Deficiencies in Accordance with the Least Burdensome Provisions was 
issued on September 29, 2017.10 The Deficiencies Guidance was updated to recommend that all 
deficiency letters include a statement regarding the basis for each deficiency and provides details 
regarding supervisory review, major/minor deficiencies, additional considerations, and 
prioritization of deficiencies. 
The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and 
Principles was issued on October 4, 2002 (2002 Least Burdensome Guidance). The guidance 
stated that, while the least burdensome provisions from FDAMA applied to PMA and 510(k) 
submissions, FDA believed that least burdensome principles should be implemented for all 
medical device premarket regulatory activities. The document also defined the term least 
burdensome and included suggested approaches for industry and FDA staff to use least 
burdensome principles in PMA and 510(k) review, including focusing on the statutory and 
regulatory criteria for marketing authorization. The guidance also described general applications 
of least burdensome approaches to activities such as postmarket controls, and recommendations 
for how the Agency should communicate requests for additional information to industry. 
This guidance document replaces the 2002 Least Burdensome Guidance. The statutory updates 
in FDASIA and the Cures Act clarified the original least burdensome provisions and further 
recognized the role of postmarket activities as they relate to premarket decisions. FDA believes, 
                                                           
7 Section 515(c)(5)(C) of the FD&C Act. 
8 Sections 513(a)(3)(D)(iii), 513(i)(1)(D)(ii), and 515(c)(5)(B) of the FD&C Act. 
9 Sections 513(a)(3)(D)(iv), 513(i)(1)(D)(iii), and 515(c)(5)(D) of the FD&C Act. 
10 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM073680. 
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as a matter of policy, that least burdensome principles should be consistently and widely applied 
to all medical device regulatory activities in the premarket and postmarket settings to remove or 
reduce unnecessary burdens so that patients can have earlier and continued access to high 
quality, safe and effective devices.  The Agency is applying tools in our implementation of these 
principles, such as regular internal training on least burdensome principles. 
This guidance, therefore, reflects FDAs belief that least burdensome principles should be 
applied throughout the medical device total product lifecycle. The least burdensome concept 
remains the same in that the principles are based on sound science, the intent of the law, the use 
of alternative approaches, and the efficient use of resources to effectively address regulatory 
issues. We have provided contemporary examples for both premarket and postmarket settings to 
demonstrate approaches that FDA and industry can take to ensure that least burdensome 
principles are implemented for all device-related applications and interactions with FDA.   
III.  Scope 
The least burdensome concept and this guidance apply to all products that meet the statutory 
definition of a device,11 including device constituent parts of combination products. The policy 
in this guidance applies to all activities (including premarket and postmarket actions) pertaining 
to the regulation of medical devices. The policy in this guidance applies, but is not limited, to: 
  Premarket submissions, including premarket approval applications (PMAs), premarket 
notifications (510(k) submissions), De Novo classification requests, humanitarian device 
exemption (HDE) applications, and investigational device exemption (IDE) applications 
  Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications 
  Additional Information and Major Deficiency Letters 
  Q-Submissions, including Pre-Submissions 
  Informal or interactive inquiries regarding device development 
  Panel review and recommendations 
  Postmarket surveillance, including Medical Device Reports (MDRs) and Post-Approval 
Studies 
  Reclassifications and 510(k) exemptions 
  Guidance documents and their application 
  Compliance-related interactions 
                                                           
11 Section 201(h) of the FD&C Act. 
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  Regulation development 
IV.  Guiding Principles  
FDA defines least burdensome to be the minimum amount of information necessary to 
adequately address a relevant regulatory question or issue through the most efficient manner at 
the right time (e.g., need to know versus nice to know). Our least burdensome definition and 
principles do not change the applicable statutory and regulatory standards, such as the device 
approval or clearance standards, nor the applicable requirements, including premarket 
submission content requirements and the requirement for valid scientific evidence.12 
Notwithstanding references to what industry should do, our guiding principles explain FDAs 
commitments for least burdensome device review. FDA intends to, and industry should, apply 
the following guiding principles when taking a least burdensome approach to a particular 
question or issue at any point in the total product lifecycle: 
1.  FDA intends to request the minimum information necessary to adequately address the 
regulatory question or issue at hand. 
2.  Industry should submit material, including premarket submissions, to FDA that are least 
burdensome for FDA to review.  
  Industry should submit well-organized, clear, and concise information. 
  Industry should not submit information unrelated to the regulatory decision to 
FDA. 
  Industry should reference applicable FDA guidance documents where FDA 
recommendations were considered. 
3.  FDA intends to use the most efficient means to resolve regulatory questions and issues.  
  FDA intends to use all reasonable measures to streamline processes and policies, 
as well as render regulatory decisions within appropriate timeframes, such as 
MDUFA performance goals.  
  FDA intends to routinely use both formal and informal interactive approaches, 
whenever possible, to resolve questions and issues.  
  FDA intends to, and industry should, use reasonable, tailored approaches that 
have been adapted to individual circumstances and needs to address regulatory 
questions and issues. 
  FDA intends to take appropriate consideration of the time and resource 
implications of its requests. 
4.  The right information should be provided at the right time (e.g., just-in-time data 
collection) to address the right questions. 
  FDA intends to, and industry should, consider the use of postmarket data 
collection to reduce premarket data collection whenever appropriate and feasible.  
                                                           
12 Sections 513(i) and 515 of the FD&C Act and 21 CFR Part 807 Subpart E, Parts 812 and 814, and 860.7(c). 
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5.  Regulatory approaches should be designed to fit the technology, taking into account its 
unique innovation cycles, evidence generation needs, and timely patient access. 
6.  FDA intends to leverage data from other countries and decisions by, or on behalf of, 
other national medical device regulatory authorities to the extent appropriate and feasible. 
7.  FDA intends to apply least burdensome principles in international medical device 
convergence and harmonization efforts. 
  FDA intends to actively engage in the development, recognition, and use of 
voluntary consensus standards published by international and other standards 
development organizations. 
Providing excellent customer service is critical to successfully applying least burdensome 
principles. FDA strives for clear and concise communication of its requests, expectations, 
processes, policies, and decisions, as well as the rationale behind them. Industry can help us 
apply least burdensome principles by providing FDA with clear and concise requests, premarket 
submissions, and responses, along with their rationales. Excellent customer service and open 
lines of communication between FDA and its customers will help to provide regulatory 
outcomes that best serve patients. 
V.  Applications of Least Burdensome Principles 
This section provides examples intended to represent the least burdensome concept and 
implementation of least burdensome guiding principles as applied to medical device regulation.13 
This includes examples of using less burdensome sources of clinical data, using nonclinical data, 
accepting alternative approaches, reducing the burden of traditional clinical studies, using 
benefit-risk assessments, streamlining processes and reducing administrative burden, engaging in 
smart regulation, participating in global harmonization, balancing premarket and postmarket 
information needs, and the use of just-in-time testing. 
Some examples may only be applicable to FDA as a regulatory authority. Even in these cases, 
FDA will continue to engage with industry on the development and implementation of least 
burdensome principles. FDA staff and industry should engage at the earliest opportunity to 
discuss the least burdensome principles and approaches that may apply to a planned submission. 
The scope of this engagement can include strategies to apply least burdensome principles and 
approaches as conveyed in this guidance document, other FDA guidance, and additional relevant 
resources. 
These examples are provided for illustration purposes and are not intended to be an exhaustive 
list. The examples are grouped by the elements of the least burdensome definition, although 
some examples could reasonably be included under multiple categories. 
A.  The minimum information necessary 
                                                           
13 The examples are for illustrative purposes only and do not constitute endorsement of any particular product by the 
FDA. 
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(1)  Less burdensome sources of clinical data 
Reasonable assurance of safety and effectiveness of a device is determined on the basis of valid 
scientific evidence.14 FDA bases its safety and effectiveness determinations on several factors, 
including, among others, intended use, conditions of use, probable benefits weighed against any 
probable risks, and the reliability of the device.15 The evidence required may vary according to 
the characteristics of the device, its conditions of use, and the extent of experience with its use, 
among other factors.16 Alternative sources of clinical data should be considered when 
appropriate, and, in many cases, may be the least burdensome means for assessing device safety 
and effectiveness and for other regulatory decision-making. Alternative sources of data may 
include peer-reviewed literature, outside the U.S. (OUS) data, real-world evidence (RWE), and 
well-documented case histories. These sources may leverage data collection and analysis using 
the Unique Device Identification (UDI) system integrated into routine healthcare delivery. These 
alternative sources of data should be considered by FDA staff and industry when determining the 
least burdensome approach to a regulatory requirement or decision. Isolated case reports, random 
experience, reports lacking sufficient details to permit scientific evaluation, and unsubstantiated 
opinions are not regarded as valid scientific evidence.17 However, when relevant, such 
information, including adverse event reports that do not constitute valid scientific evidence, may 
be considered in identifying a device the safety and effectiveness of which is questionable.18 
Leveraging existing data 
The use of existing data to inform regulatory decisions can be a scientifically valid application of 
the least burdensome principles. When available, appropriate, and relevant to the specific device 
or regulatory issue at hand, peer-reviewed literature, registry data, and OUS data may be used in 
lieu of, or to supplement, other data. For example, FDA approved an HDE to treat pediatric 
esophageal atresia based on a combination of published literature and well-documented 
compassionate use cases.19 Likewise, FDA relied extensively on peer-reviewed literature to grant 
a De Novo request for a direct to consumer genomic panel for risk assessment of genetic 
diseases, including Parkinsons Disease and late-onset Alzheimers Disease.20 Finally, peer-
reviewed literature has been used to support expanded indications for use or other labeling 
changes in 510(k) submissions for many device types.21 
 
Under appropriate circumstances, FDA and applicants may also leverage information contained 
in a previously filed PMA, including information from clinical or preclinical tests or studies that 
demonstrate a reasonable assurance of the safety and effectiveness of a device, but excluding 
descriptions of methods of manufacture, product composition, and other trade secrets. According 
                                                           
14 21 CFR 860.7(c)(1). 
15 21 CFR 860.7(b). 
16 21 CFR 860.7(c)(2). 
17 Id. 
18 Id. 
19 Summary of Safety and Probable Benefit available at: 
https://www.accessdata.fda.gov/cdrh_docs/pdf15/H150003B.pdf.  
20 De Novo Decision Summary available at: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN160026.pdf.  
21 See, e.g., 510(k) summaries available at: https://www.accessdata.fda.gov/cdrh_docs/pdf16/K161949.pdf, 
https://www.accessdata.fda.gov/cdrh_docs/pdf16/K163245.pdf, 
https://www.accessdata.fda.gov/cdrh_docs/pdf14/K142973.pdf, and 
https://www.accessdata.fda.gov/cdrh_docs/pdf17/K172903.pdf. 
 
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to the six-year rule,22 while excluding trade secrets, FDA may use safety and effectiveness data 
from clinical or preclinical tests or studies, six years after PMA approval, in order to approve 
another applicants device, establish a performance standard or special control, or classify or 
reclassify another device under section 513 of the FD&C Act. The Agency decided to apply the 
six-year rule only to data in PMAs approved after November 28, 1990, the date of enactment of 
the Safe Medical Devices Act (Public Law 101-629) (SMDA). For example, FDA used the six-
year rule upon our own initiative to support the reclassification of stair-climbing wheelchairs and 
sharps needle destruction devices from Class III to Class II with the establishment of special 
controls.23 For more information on the six-year rule, see the FDA guidance document Guidance 
on Section 216 of the Food and Drug Administration Modernization Act of 1997.24 
The extrapolation of existing clinical data from a studied patient population into a new pediatric 
patient population should be considered when endpoints present in the existing data source are 
relevant, there are no differences between adult and pediatric use that could impact safety and 
effectiveness, and the quality of data is sufficient. For more information on when and how to 
extrapolate adult data for pediatric populations, see the FDA guidance document Leveraging 
Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices.25 
Real-world evidence (RWE) 
Real-World Data (RWD) are data relating to patient health status and/or the delivery of health 
care routinely collected from a variety of sources. RWE is the clinical evidence regarding the 
usage and potential benefits or risks of a medical product derived from analysis of RWD. RWD 
may originate from electronic health records (EHRs), registries, and medical administrative 
claims data. For more information about RWE, see the FDA guidance document Use of Real-
World Evidence to Support Regulatory Decision-Making for Medical Devices.26 
FDA and industry are using RWD sources to address both premarket and postmarket issues. 
FDA approved a PMA for a permanent pacemaker electrode using clinical data captured through 
a remote monitoring system in a prospective registry.27 In addition, a publicly-available database 
that includes patient registry data for cystic fibrosis variants was used to support the clinical 
validity of variants reported in a 510(k) that was cleared for a cystic fibrosis transmembrane 
conductance regulator (CFTR) assay.28 A curated precision oncology knowledge database was 
used to support mutation reporting for a De Novo request that was granted for a next generation 
sequencing tumor profiling test.29 Several registries initially designed for postmarket surveillance 
                                                           
22 Section 520(h)(4) of the FD&C Act. 
23 The final reclassification orders were issued on April 14, 2014 (79 FR 20779) and May 4, 2018 (83 FR 19626), 
respectively. 
24
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073709.p
df.  
25 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM444591. 
26 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM513027. 
27 Summary of Safety and Effectiveness Data available at: 
https://www.accessdata.fda.gov/cdrh_docs/pdf12/P120017b.pdf.  
28 510(k) and FDA Decision Summaries available at: https://www.accessdata.fda.gov/cdrh_docs/pdf12/K124006.pdf 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K124006. 
29 De Novo Decision Summary available at: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170058.pdf. 
 
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have been used to support expanded indications for devices such as ventricular support devices 
and transcatheter valves.30 Finally, FDA and industry leveraged RWE generated from a registry 
to support expanded indications for use for a cryosurgical tool intended for benign and malignant 
lesion ablation.31 
(2)  Use of nonclinical data 
Nonclinical data are often routinely collected as part of the product development process. In 
some cases, this may include the use of benchtop models, nonclinical literature, use of tissue 
phantoms, or computer modeling and simulations based on recognized standards. Especially in 
situations where testing modalities are representative or predictive of clinical performance, FDA 
frequently relies upon nonclinical testing in lieu of or to supplement clinical data. For example, 
FDA has approved magnetic resonance (MR) conditional labeling for pacemakers, cardiac 
resynchronization therapy devices, and implantable cardioverter defibrillators based, in part, on 
validated computer modeling. FDA has also accepted cadaver images in lieu of imaging from 
live subjects for certain imaging indications such as extremity imaging. 
While clinical data may sometimes be necessary to meet a regulatory requirement, nonclinical 
data should be considered as a replacement for clinical data, when appropriate. The use of 
descriptive information, in vitro studies, computer modeling and simulations, and/or animal 
performance data that could be responsive to an outstanding regulatory question should be 
considered before requesting clinical data.32 
Bottom-up approach to data requests 
FDA often identifies the need for additional information to make a decision on a marketing 
submission. These requests for additional information, colloquially known as deficiencies, can 
include requests for additional descriptive information, nonclinical, or clinical performance data. 
Data requests from FDA should follow a stepwise analytical process to ensure that each request 
reflects the least burdensome approach. Consistent with the Deficiencies Guidance, all 
deficiencies should acknowledge information submitted, explain why it is not adequate to 
address the issue, explain the relevance of the request to the marketing submission decision, and 
explicitly request information.  
This logic has been used for 510(k) submissions to ensure application of least burdensome 
principles. FDA should first consider whether descriptive information is sufficient. While few 
510(k) submissions rely solely on descriptive information, FDA and industry should consider 
this approach. For example, dimensional analysis between devices manufactured from the same 
or similar materials have been used to support the rationale for substantially equivalent 
performance for some orthopedic bone plate and screw 510(k) submissions. 
                                                           
30 See, e.g., Summaries of Safety and Effectiveness Data available at: 
https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140003S018B.pdf and 
https://www.accessdata.fda.gov/cdrh_docs/pdf13/p130009s034b.pdf. 
31 510(k) Summary available at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171626.pdf.  
32 FDA supports the principles of the 3Rs, to reduce, refine, and replace animal use in testing when feasible. We 
encourage sponsors to consult with us if it they wish to use a non-animal testing method they believe is suitable, 
adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency 
to an animal test method. 
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When descriptive information is not sufficient, FDA and industry should then consider whether 
nonclinical performance testing or analytical studies using clinical samples could address the 
issue. Nonclinical animal and/or biocompatibility studies are typically requested when other 
forms of nonclinical bench performance testing are not sufficient to demonstrate substantial 
equivalence. When analytical or nonclinical bench testing, or nonclinical animal testing and/or 
biocompatibility studies are insufficient, FDA may request clinical performance data. For more 
information about how FDA has used this process in 510(k) submissions, see the FDA guidance 
document The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 
[510(k)].33  
Use of nonclinical bench performance testing 
Bench performance testing should be considered to address nonclinical or clinical endpoints, 
when appropriate. This may include bench models for anatomy, such as evaluating tortuous 
paths for catheters used across many clinical applications. The use of tissue phantoms has also 
increased for evaluating the magnetic resonance imaging compatibility of implants and tissue 
effects from high intensity therapeutic ultrasound. Bench performance testing may not be an 
appropriate surrogate when the methods do not correspond with clinically-relevant scenarios. 
Computer modeling and simulations (CM&S) 
CM&S should be used to support medical device safety and effectiveness as an alternative or 
supplement to traditional benchtop or animal performance testing in appropriate circumstances. 
The use of CM&S can reduce design verification time or cost and serve as a tool for design 
validation. For example, CM&S has been used to predict mechanical properties for 
cardiovascular and orthopedic devices under simulated loading conditions. Additionally, CM&S 
has been used to estimate the radiofrequency energy absorbed by patients undergoing magnetic 
resonance imaging (MRI) to assess medical device safety. FDAs recommendations regarding 
the use of CM&S in submissions are included in the FDA guidance document Reporting of 
Computational Modeling Studies in Medical Device Submissions.34 
(3)  Acceptance of alternative approaches 
Alternative approaches should be considered, when appropriate, to optimize the time and 
resources of FDA and industry. Both FDA and industry should understand that there are often 
multiple ways to satisfactorily address a particular regulatory issue. The resolution of the 
regulatory issue should be based on a discussion about which method is least burdensome, while 
still satisfactorily addressing the regulatory issue. 
Resolution of scientific issues 
The acceptance of alternative approaches for the evaluation of scientific issues identified during 
the premarket review of a novel medical device is a common application of least burdensome 
principles. FDA and industry should be flexible and open-minded in determining the most 
efficient mechanism and minimum information necessary to address a specific issue. In some 
cases, a justification, in lieu of additional data, may be acceptable to address an issue. When 
discussing alternative approaches, FDA intends to take appropriate consideration of the time and 
resource implications of our additional information requests. 
                                                           
33 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284443.   
34 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM381813.  
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A common example of FDA accepting alternative approaches includes the biocompatibility of 
medical devices. When appropriate, FDA and industry have leveraged OUS clinical data or large 
animal safety studies to address certain biocompatibility endpoints. Additionally, the use of 
rationales based on materials properties, chemistry, and processing have been leveraged as 
alternatives to repeat testing. For example, manufacturers often modify the tips of their vascular 
catheters and, instead of repeat testing, leverage prior testing conducted on another vascular 
device for which the same materials and processing methods were used. 
Another common example concerns the review of nonclinical testing in regulatory submissions. 
Through requests for additional information, the Agency may identify one particular method for 
addressing a scientific issue. When appropriate, FDA should identify when alternative 
approaches or justifications would resolve the issue under discussion. Common examples include 
leveraging existing device information such as mechanical testing, software validation, and 
sterilization validation. For example, FDA often requests additional bench testing results to 
address differences in technological characteristics for devices with multiple sizes or models to 
support substantial equivalence determinations. In consultation with the applicant, FDA has 
accepted alternative testing and scientific justifications in lieu of previously requested testing for 
certain device types, for which worst-case testing scenarios can be reasonably justified based on 
size. In other cases, FDA has requested mechanical testing for certain bone plates or screws, but 
accepted alternative approaches that included detailed engineering analyses in lieu of testing to 
support substantial equivalence.  
Considering alternative labeling 
Applicants propose labeling, including indications for use (IFU), in their regulatory applications. 
If a labeling statement or proposed IFU is not supported by the submitted evidence and would 
otherwise result in an adverse decision, such as a not substantially equivalent determination for a 
510(k), FDA staff and industry should discuss both (1) a labeling statement or an IFU, if any, 
that can be supported by the information submitted to FDA, and (2) the minimum information 
that would support the sought-after labeling statement or IFU. The applicant can then choose 
which avenue they wish to pursue within statutory and MDUFA deadlines. For example, FDA 
and industry have used this approach by limiting specific statements in the proposed labeling to 
those that support marketing authorization for a device. 
In other cases, the addition of specific warnings or precautions to the device labeling may 
provide sufficient risk mitigation to support a favorable decision. For example, FDA has 
accepted certain risk mitigations through labeling instead of fail-safe and failure alert 
mechanisms in the devices design during the review of CLIA Waiver by Applications for in 
vitro diagnostic devices (IVDs). 
B.  The most efficient means 
(1)  Reducing the burden of traditional clinical studies 
When clinical data are necessary, FDA and industry should consider the most efficient means of 
obtaining the evidence necessary to meet the regulatory need or standard. For example, the PMA 
requirements for a Class III device include providing a reasonable assurance of safety and 
14 
  Contains Nonbinding Recommendations 
effectiveness.35 In many cases, alternatives to randomized controlled studies may be sufficient 
and constitute valid scientific evidence. In appropriate circumstances, FDA has accepted 
historical controls, the use of objective performance criteria (OPC), performance goals (PGs), 
and alternative sources of data, including evidence from registries, claims data, and published 
literature. For more information about design considerations for clinical studies, see the FDA 
guidance document Design Considerations for Pivotal Clinical Investigations for Medical 
Devices.36 
Historical control groups 
The use of historical control groups involves quantitatively comparing the results of use of the 
device with prior experience derived from the adequately documented natural history of a 
disease or condition in comparable patients or populations who received no treatment or who 
followed an established effective regimen (therapeutic, diagnostic, prophylactic).37 The use of 
historical control groups may reduce the number of patients enrolled in clinical studies while 
retaining their strength as well-controlled clinical investigations. FDA and industry have used 
historical control groups in the evaluation of generic types of devices including, but not limited 
to, transcatheter aortic valves, hip resurfacing devices, total knee and ankle replacements, 
neurostimulators, and diagnostic devices using single-arm clinical study designs to assess safety 
and effectiveness. 
Non-comparative clinical outcome studies 
Non-comparative clinical outcome studies can include those using OPCs, PGs, observational 
studies, registries, meta-analysis, and literature summaries. OPC refers to a target value derived 
from historical data within clinical studies or registries and is used in a pass/fail manner to assess 
safety and effectiveness endpoints. PG is a numerical value used as a comparison for safety 
and/or effectiveness endpoints that may be accepted or developed by a professional society, 
standards development organization, or FDA. The use of single-group studies compared to an 
OPC or PG can reduce the sample size necessary to support marketing authorization. 
In device types where existing data can be leveraged to set OPCs, such as heart valves,38 clinical 
studies are then routinely performed using those OPCs. In another case where less data was 
available, FDA, in consultation with industry and the Obstetrics and Gynecology Devices 
Advisory Panel, leveraged five PMA approvals with similar control data to establish an OPC for 
endometrial ablation devices to give applicants the option to conduct a single-arm study.39 An 
OPC was also used to support the substantial equivalence of a distal embolic protection device.40  
While not considered as robust as an OPC, PGs might be considered for challenging patient 
populations or if there is no clinical equipoise for any control. PGs have been used in PMAs to 
                                                           
35 Section 515 of the FD&C Act. 
36 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM373766.   
37 21 CFR 860.7(f)(1)(iv)(d). 
38 See, e.g., Summary of Safety and Effectiveness Data available at: 
https://www.accessdata.fda.gov/cdrh_docs/pdf15/p150036b.pdf and 
https://www.accessdata.fda.gov/cdrh_docs/pdf13/P130011b.pdf.  
39 FDA Letter to Global Endometrial Ablation Manufacturers is available at: 
https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM470246.pdf.  
40 510(k) Summary available at: https://www.accessdata.fda.gov/cdrh_docs/pdf8/K083300.pdf. 
 
15 
  Contains Nonbinding Recommendations 
support determinations of a reasonable assurance of safety and effectiveness for peripheral 
vascular stents.41 The substantial equivalence of a software device to analyze physiological 
signals and score sleep study results was supported in part by the use of PGs.42  
Subject as own control 
When possible, FDA and industry should consider when subjects in clinical studies can serve as 
their own controls to minimize the number of enrolled patients. Cross-over study designs, where 
each subject receives the treatment and control interventions sequentially in a randomized order, 
have been used for clinical studies involving many different devices including obesity devices, 
dermal fillers, and neurostimulators. Paired designs, where a patient serves as his/her own 
concurrent control, have been used in split-face study designs to assess plastic surgery devices 
and split-knees designs to assess orthopedic devices. IVD studies have also used patients as their 
own controls, for example, to assess the long-term performance of colorectal cancer screening 
tests. 
Adaptive study designs 
The use of adaptive study designs may reduce resource requirements, decrease time to study 
completion, and/or increase the chance of study success. For more information, see the FDA 
guidance document Adaptive Designs for Medical Device Clinical Studies.43 Adaptive study 
designs have been used to minimize the number of study subjects for premarket and postmarket 
studies for neurological and cardiovascular device types. 
 
Use of alternatives to prospective sample collection 
Certain circumstances can make prospective patient samples for IVDs impractical, such as the 
low prevalence of a condition or the rarity of measuring certain concentration levels in a clinical 
setting. In such cases, alternative approaches to sample collection should be considered, such as 
the use of banked and retrospective samples, contrived samples, and surrogate samples or 
biomarkers. 
(2)  Use of benefit-risk assessments 
Least burdensome principles are consistent with FDAs approach to weighing benefits and risks 
in regulatory decision-making for medical devices. All regulatory processes involve some 
uncertainty about the benefits and risks of a medical device. In some circumstances, greater 
uncertainty may be appropriate, such as when the probable benefits are high (e.g., a breakthrough 
device) or the probable risks of the device are low. 
In determining the safety and effectiveness of a device, FDA considers, among other factors, the 
probable benefit to health from the use of the device weighed against any probable injury or 
illness from such use.44 The extent (e.g., probability, magnitude/severity, and duration) of both 
benefit and risk are considered along with uncertainty, patient-centric metrics and perspective, 
                                                           
41 Summary of Safety and Effectiveness Data available at: 
https://www.accessdata.fda.gov/cdrh_docs/pdf9/P090006b.pdf and 
https://www.accessdata.fda.gov/cdrh_docs/pdf12/P120020b.pdf. 
42 510(k) Summary available at: https://www.accessdata.fda.gov/cdrh_docs/pdf16/K162627.pdf. 
43 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM446729.  
44 21 CFR 860.7(b)(3).  
 
16 
  Contains Nonbinding Recommendations 
and a characterization of the disease. A positive decision may be rendered when FDA determines 
that the probable benefits to health outweigh any probable risks and that the device will provide 
clinically significant results.45 For example, despite the occurrence of serious adverse events and 
death in clinical studies and OUS registries for a mitral valve repair device, FDA determined that 
there was a narrow patient population with low life expectancy and quality of life for which the 
probable benefits outweigh the probable risks.46 This device provided an unmet clinical need for 
treatment in patients who were not candidates for mitral valve surgery. Taking into account the 
benefit-risk assessment, FDA determined that the device has a reasonable assurance of safety and 
effectiveness for this narrow patient population. 
For more information about using benefit-risk in PMA and De Novo request decisions, see the 
FDA guidance document Factors to Consider When Making Benefit-Risk Determinations in 
Medical Device Premarket Approval and De Novo Classification.47 
(3)  Streamlining processes and reducing administrative burden 
Least burdensome principles also apply to streamlining regulatory processes to improve 
efficiency. FDA has implemented several policies and practices to reduce administrative burden, 
eliminate potential redundancies, and conserve both FDA and industry resources.  
Reducing redundancies 
The inclusion of multiple devices or indications within a bundled marketing submission or the 
use of dual submissions can limit redundant submission and review of regulatory information by 
FDA and industry. Bundling is appropriate for generic types of devices with scientific and 
regulatory issues that can be most efficiently addressed during one review. For more information 
about bundling, see the FDA guidance document Bundling Multiple Devices or Multiple 
Indications in a Single Submission.48 
The dual 510(k)/CLIA Waiver permits the concurrent review of a 510(k) submission and CLIA 
Waiver by Application. FDA and industry work collaboratively to develop comparison and 
reproducibility study designs to generate one data set that should reduce study-related costs and 
review time. For more information about the dual 510(k)/CLIA Waiver, see the FDA guidance 
document Administrative Procedures for CLIA Categorization.49 
Submission efficiencies 
Rather than receiving detailed submissions for all devices subject to premarket notification 
requirements under section 510(k) of the FD&C Act, FDA established the New 510(k) Paradigm 
with two optional approaches to demonstrate substantial equivalence. The Special 510(k) 
program leverages the Quality System (QS) Regulation and design controls and the Abbreviated 
510(k) program leverages guidance documents, FDA-recognized voluntary consensus standards, 
                                                           
45 21 CFR 860.7(d)-(e). 
46 Summary of Safety and Effectiveness Data available at: 
https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100009B.pdf.  
47 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM517504.   
48 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM089732.   
49 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM070889.   
 
17 
  Contains Nonbinding Recommendations 
and/or special controls. One goal of both programs is to streamline 510(k) review either by 
reduced review time or administrative burden without compromising the quality of a substantial 
equivalence decision. For more information about the Special and Abbreviated 510(k) programs, 
see the FDA guidance document The New 510(k) Paradigm  Alternate Approaches to 
Demonstrating Substantial Equivalence in Premarket Notifications.50 
PMA annual reports can be used to summarize design, labeling, and manufacturing changes that 
do not affect safety and effectiveness. FDAs recommended format for design, manufacturing, 
and labeling changes outlined in the guidance document Annual Reports for Approved 
Premarket Approval Applications (PMA)51 is an efficient method for industry to submit and for 
FDA to assess the changes, including determining whether reportable changes require a PMA 
Supplement in accordance with 21 CFR 814.39. 
The electronic submission of material to the Agency can reduce the administrative burden on 
manufacturers. For example, reports of corrections and removals can be sent to FDA using the 
eSubmitter tool and Electronic Submission Gateway.52 Additionally, allegations of regulatory 
misconduct can be submitted using a uniform, web-based template that is transmitted to FDA via 
email, rather than by postal mail.53  
Medical Device Development Tools (MDDTs) 
An MDDT is a method, material, or measurement used to assess the effectiveness, safety, or 
performance of a medical device. MDDTs are tools that can be qualified and used to streamline 
device development and regulatory evaluation. After qualification, the MDDT is considered a 
valid tool to support regulatory decision-making for devices by FDA within the specified context 
of use. The efficient use of qualified MDDTs can reduce device development costs and FDA 
review times because these methods can be used without FDA reviewing their validity each time. 
For example, FDA qualified two patient-reported outcome questionnaires that can be used to 
support regulatory submissions for devices.54 For more information about MDDTs, see the FDA 
guidance document Qualification of Medical Device Development Tools.55 
Medical Device Reporting (MDR) 
Reducing the burden of MDRs has been executed through enhancements to existing processes. 
The Electronic MDR (eMDR) system has been implemented to fast-track the generation, 
                                                           
50
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080189.p
df. 
51 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM089398. 
52 For more information, see: 
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/RecallsC
orrectionsAndRemovals/UCM573289.pdf.  
53 For more information, see: 
https://www.fda.gov/medicaldevices/safety/reportingallegationsofregulatorymisconduct/default.htm.  
54 MDDT Qualification Decision Summaries available at: 
https://www.fda.gov/downloads/MedicalDevices/ScienceandResearch/MedicalDeviceDevelopmentToolsMDDT/UC
M604232.pdf and 
https://www.fda.gov/downloads/MedicalDevices/ScienceandResearch/MedicalDeviceDevelopmentToolsMDDT/UC
M581761.pdf. 
55 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM374432.   
 
18 
  Contains Nonbinding Recommendations 
submission, and review of MDRs. The use of eMDR expedites report processing and reduces the 
data entry burden on industry, FDA, healthcare facilities, and importers. For more information 
about eMDR, see the FDA guidance document Questions and Answers about eMDR  Electronic 
Medical Device Reporting.56 
Alternative summary MDR reporting can be requested by persons and entities that are not 
exempt from mandatory reporting. FDA may grant an alternative, or full or partial exemption 
from the MDR regulations.57 For example, manufacturers may request that reports be submitted 
quarterly, semiannually, or annually instead of 30 calendar days after becoming aware of the 
reportable event. Additionally, manufacturers can request that reports only contain a subset of 
the data required by the MDR regulations. Registry data used for postmarket surveillance has 
allowed manufacturers to apply for alternative summary reporting where only certain adverse 
events must be reported to the FDA. In some cases, FDA has allowed manufacturers to provide a 
summary MDR report generated from a specific registry each quarter. These approaches can 
streamline the drafting and submission of MDRs for industry, and review of MDRs by the 
Agency, while maintaining or enhancing the quality, utility, and clarity of MDRs through a more 
holistic view of reportable event trends. For more information about alternative summary and 
summary MDR reporting, see the FDA guidance documents Medical Device Reporting  
Alternative Summary Reporting (ASR) Program58 and Medical Device Reporting for 
Manufacturers.59 
(4)  Smart regulation 
The application of least burdensome principles should include a regular reexamination of the 
regulatory paradigm for medical devices to ensure that existing regulatory processes are still the 
most efficient and request the minimum information necessary. The type and amount of 
minimum information requested by FDA can change over time based on new information that 
the Agency receives and a better understanding of the technology. As specific medical 
technologies become better understood from a scientific and clinical perspective, FDA should 
periodically assess the appropriateness of data requests in premarket submissions, evaluate 
premarket and postmarket balance, determine whether devices are candidates for reclassification, 
and implement changes when appropriate. Such an evaluation may help FDA focus on issues of 
higher public health concern. FDA may communicate such changes through guidance, written 
order, or by regulation, as appropriate.   
Exemption from 510(k) 
Central to reexamination of regulatory processes is the consideration of whether premarket 
submissions are necessary to reasonably assure a devices safety and effectiveness. In 
accordance with the FD&C Act, as amended by the Cures Act, FDA published notices 
                                                           
56
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm179471.p
df.  
57 21 CFR 803.19. 
58 
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072102.p
df.  
59 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM359566.   
 
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exempting numerous Class II and Class I device types from 510(k) requirements.60 FDA is also 
required to periodically publish a list of device types for which a 510(k) submission is no longer 
necessary to provide a reasonable assurance of safety and effectiveness.61  
(5)  Global harmonization 
Harmonization and regulatory convergence is a process whereby regulatory recommendations or 
requirements across different countries or regions become aligned over time using international 
guidance documents, consensus standards, policies, and procedures. Efforts to advance 
international harmonization and regulatory convergence should be viewed as applying the least 
burdensome concept by using the most efficient means to achieve regulatory goals. While U.S. 
statutes and regulations may not be identical to those of other countries, FDA should align itself 
with international regulatory authorities whenever practicable and possible. 
Reliance on voluntary consensus standards 
The development and FDA recognition of voluntary consensus standards allows FDA, industry, 
and other stakeholders to agree upon process, methods, and acceptance criteria that may be used 
to support the safe and effective use of medical devices. FDA intends to consider least 
burdensome principles when participating in the development and recognition of voluntary 
consensus standards. The recognition and appropriate use of standards can streamline 
interactions between FDA and industry. When recognized and used by multiple regulatory 
authorities, standards can also support global harmonization by creating consistent approaches to 
medical device development, manufacturing, and evaluation.  
In the absence of a recognized consensus standard, evaluation of performance data involves the 
submission and review of complete test protocols and data reports. By providing a declaration of 
conformity to FDA-recognized standards with explicit valid and reliable testing methods, 
applicants and FDA may not need to discuss whether test methods are scientifically valid and 
can focus their resources on reviewing the test results. When consensus standards include both 
explicit test methods and either performance limits and/or acceptance criteria, a declaration of 
conformity can potentially replace the submission and review of both the test methods and 
complete data in a premarket submission. FDA accepts declarations of conformity to several 
standards without requesting accompanying testing data to support regulatory submissions of 
many generic device types. For more information, see section 514(c) of the FD&C Act and the 
FDA guidance document Appropriate Use of Voluntary Consensus Standards in Premarket 
Submissions for Medical Devices.62 
International Medical Device Regulators Forum (IMDRF)     
FDA intends to use least burdensome principles when contributing to harmonization efforts, such 
as participation in the IMDRF. IMDRF is a voluntary group of international regulatory 
authorities intended to build on previous work from the Global Harmonization Task Force 
(GHTF). Harmonization is least burdensome because it can allow manufacturers to meet the 
regulatory requirements of more than one international regulatory authority without duplicating 
efforts. FDAs participation in IMDRF to develop and advance essential principles for the 
                                                           
60 Sections 510(l)(2) and (m)(1) of the FD&C Act. The final exemption notices for Class I and Class II devices were 
published in the Federal Registers of April 13, 2017 (82 FR 17841) and July 11, 2017 (82 FR 31976), respectively. 
61 Sections 510(l)(2) and (m)(1) of the FD&C Act. 
62 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM077295.   
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regulation of devices, internationally recognized guidance documents, and auditing practices all 
support convergence across multiple regulatory jurisdictions. For example, this includes the 
piloting of the Table of Contents (ToC) format for regulatory submissions. Harmonization of the 
format for content required for marketing submissions with those of international regulatory 
authorities can streamline applicant efforts to address a regulatory issue. In addition, FDAs 
involvement with the various IMDRF working groups allows for international harmonization of 
premarket and postmarket regulatory requirements in areas such as clinical evaluation and 
Quality Management Systems for Software as a Medical Device (SaMD) and terminology for 
adverse event reporting.  
Medical Device Single Audit Program (MDSAP) 
MDSAP is a program that applies the least burdensome principles by allowing for one audit to 
satisfy the requirements of multiple regulatory jurisdictions. The goal is to reduce regulatory 
burden on industry by minimizing the number of regulatory audits, potentially redundant 
requests, or disruption of business when audits are initiated separately by different international 
regulatory authorities. 
C.  The right time 
(1)  Balancing premarket and postmarket information needs 
Striking the right balance between premarket and postmarket information needs is a guiding 
principle of the least burdensome concept. This balance is intended to address obtaining the 
minimum necessary information at the right time in the total product lifecycle. As discussed in 
the Background (section II), the FD&C Act requires FDA to consider the role of postmarket 
information when making a determination of the least burdensome means of demonstrating a 
reasonable assurance of safety and effectiveness for PMAs.63 FDA and industry should consider 
the appropriate balance between premarket and postmarket information needs for all medical 
device regulatory issues, when applicable. 
Reviewing only some changes 
FDA and industrys reliance on the Quality System (QS) Regulation (21 CFR Part 820) is 
another example of the application of least burdensome principles that supports efficiency. 
Manufacturers can make certain design changes to cleared devices and labeling without reporting 
under section 510(k) of the FD&C Act. This approach balances premarket and postmarket 
information for 510(k)-regulated devices and encourages both FDA and industry to use a risk-
based assessment to determine whether changes could significantly affect safety or effectiveness. 
For more information, see the FDA guidance documents Deciding When to Submit a 510(k) for 
a Change to an Existing Device64 and Deciding When to Submit a 510(k) for a Software Change 
to an Existing Device.65 
Total product lifecycle approach 
FDA should only request information that is necessary to make a given regulatory decision. 
When requesting information, FDA should assess the right time for obtaining necessary 
                                                           
63 Section 515(c)(5)(C) of the FD&C Act. 
64 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM514771.   
65 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM514737.   
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  Contains Nonbinding Recommendations 
information and determine whether a shift from premarket to postmarket evaluation is 
appropriate while still reasonably assuring device safety and effectiveness. Reliance on 
postmarket controls, such as the QS Regulation, post-approval studies (PAS), postmarket 
surveillance, and MDR, should be considered when determining the suitability for devices for 
the market. In some cases, FDA has determined that premarket review is not required to 
reasonably assure a devices safety and effectiveness. For example, some medical devices that 
are exempt from premarket review rely on the QS Regulation and other postmarket controls to 
reasonably assure their safety and effectiveness.66 
In other cases, certain safety and effectiveness questions may be appropriately and efficiently 
answered in a postmarket setting. For example, long-term safety and effectiveness questions for 
a leadless pacemaker were addressed through PAS. Analytical studies for long-term outcomes 
regarding companion diagnostics have also been addressed in a postmarket setting, when 
appropriate.  
As part of FDAs 2014-2015 Strategic Priority Strike the Right Balance Between Premarket and 
Postmarket Data Collection, FDA completed a review of 200 product codes of devices subject 
to the PMA review process to assess whether these devices were candidates for a 
premarket/postmarket shift of data capture or reclassification. The initial review was completed 
and published in the Federal Register to seek stakeholder comments.67 As a result of this review 
and after issuing proposed orders for comment, FDA published final orders that reclassified 
salivary stimulators, sharps needle destruction devices, and single-use internal condoms from 
Class III (premarket approval) to Class II (special controls), subject to premarket notification 
requirements under section 510(k) of the FD&C Act.68 In accordance with section 608(c) of 
FDASIA, FDA maintains a website summarizing the devices reclassified since 2013.69 For more 
information regarding FDAs approach to premarket/postmarket balance and specific examples 
of devices where this approach was implemented, see the guidance document Balancing 
Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval.70 
(2)  Just-in-time testing 
The device evaluation strategy in early feasibility studies can be used to promote the right time 
principle for IDE applications. Early feasibility studies, including certain first in human studies, 
may be based on less nonclinical data than would be expected for a traditional feasibility or 
pivotal study. At the manufacturers discretion, the device evaluation strategy can be used to 
transparently establish a timeline for deferred or additional nonclinical testing as the company 
proceeds to subsequent clinical studies. The goal of FDAs policy on IDEs for early feasibility 
studies is to facilitate the initiation of clinical studies in the United States earlier in the device 
development process than what has historically occurred, while ensuring the study has 
                                                           
66 510(k)-exempt devices can be found at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm. 
67 The notices were published on April 29, 2015 (80 FR 23798) and August 8, 2016 (81 FR 52445), respectively. 
68 The final reclassification orders were published on November 20, 2015 (80 FR 72585), May 4, 2018 (83 FR 
19626), and September 27, 2018 (83 FR 48711), respectively. 
69 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/
ucm378724.htm. 
70 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM393994.   
 
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acceptable human subject protection measures for its participants. For more information, see the 
guidance document Investigational Device Exemptions (IDEs) for Early Feasibility Medical 
Device Clinical Studies, Including Certain First in Human (FIH) Studies.71 
VI.  Compliance Policies that Support the Goals of the Least 
Burdensome Concept
 
The compliance policies below help support the goals of the least burdensome concept by 
allowing for more efficient and effective use of resources by both FDA and industry.  
Enforcement discretion policy 
In some cases, FDA has published guidance documents communicating that the Agency does not 
intend to examine whether certain products comply with premarket review and postmarket 
regulatory requirements for devices under the FD&C Act and its implementing regulations, 
including, but not limited to: registration and listing and 510(k) requirements; labeling 
requirements; current good manufacturing practice requirements as set forth in the QS 
Regulation; and MDR requirements.72 Although these guidances do not change or otherwise 
affect any requirements of the FD&C Act or any applicable regulations, FDA has used this 
approach for products such as mobile medical applications and general wellness products so that 
FDA can focus its oversight on those medical devices whose functionality could pose a higher 
risk to patients. For more information, see the FDA guidance documents Mobile Medical 
Applications73 and General Wellness: Policy for Low Risk Devices.74 
Medical necessity for marketed devices 
FDA recognizes that devices may have benefit even when the devices fail to meet some 
regulatory requirements. When contemplating exercising enforcement discretion for a violative 
device, FDA considers the needs of patients and clinicians. In cases when there are no alternative 
devices, or the risk associated with changing to an alternative is greater than the risk associated 
with the violative devices, FDA can determine the violative devices to be medically necessary 
for some situations. For example, FDA may exercise discretion by not taking enforcement action 
against a violative device, in order to address patient and clinician need. FDA bases this 
determination on benefit-risk principles and revisits the analysis as new information becomes 
available. 
For more information about using benefit-risk in compliance/enforcement decisions, see the 
FDA guidance document Factors to Consider Regarding Benefit-Risk in Medical Device Product 
Availability, Compliance, and Enforcement Decisions.75 
Feedback regarding inspectional observations 
In accordance with section 704(h)(2) of the FD&C Act, as amended by the FDA Reauthorization 
Act of 2017 (Public Law 115-52), device establishments may request feedback for actions 
                                                           
71 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM279103.  
72 21 CFR Part 807, Part 801 and 809.10, Part 820, and Part 803, respectively. 
73 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.   
74 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM429674.   
75 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM506679.  
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  Contains Nonbinding Recommendations 
proposed to be taken in response to the observations noted during an inspection and provided 
pursuant to section 704(b) of the FD&C Act that involve a public health priority, implicate 
systemic or major actions, or relate to emerging safety issues. In response to such a request and 
in accordance with section 704(h)(2) of the FD&C Act, FDA will provide nonbinding feedback 
on actions proposed to address the observations. This allows for firms to understand whether 
they are on the right track and can resolve issues that may otherwise escalate to regulatory 
action. Such interactions can reflect least burdensome principles when the firm only provides 
information relevant to the observations and such information is organized to facilitate Agency 
review. 
VII. Conclusion 
This guidance reflects the principle that medical device regulation should be least burdensome 
across the total product lifecycle. FDA intends to request the minimum amount of information 
necessary to adequately address a relevant regulatory question or issue through the most efficient 
manner at the right time. Industry should provide information to FDA that is least burdensome 
for FDA to review. Open lines of communication between FDA and industry will provide 
regulatory outcomes that best serve patients. Successful application of least burdensome 
principles will ensure that patients have access to high-quality, safe and effective medical 
devices. 
24