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The Least Burdensome Provisions: 

Concept and Principles

Joshua Silverstein

Regulatory Advisor

Office of Device Evaluation 

Center for Devices and Radiological Health 

(CDRH)

March 14, 2019
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This presentation will cover:

–Background 

–Summary of Final Guidance

– Update on Implementation Efforts

–Questions and Answers

Agenda
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Objectives

After this webinar, you should know:

• Least burdensome principles apply across the total product lifecycle and 

enables the FDA to focus resources on the issues of highest public health 

concern.

• The FDA has identified guiding principles to support a least burdensome 

approach to device regulation

• Select examples of how the FDA and industry have used a least burdensome 

approach

• How the FDA is implementing these changes to the least burdensome approach

• Implementation of least burdensome upholds our stringent review standards and 

maintains the scientific integrity of our decision-making process.
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• Congress added the least burdensome provisions to the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) in the FDA Modernization Act of 

1997

• CDRH issued three final guidances on least burdensome from 2000-

2002:

– “The Least Burdensome Provisions of the FDA Modernization Act 

of 1997: Concept and Principles”

– “Suggested Format for Developing and Responding to Deficiencies 

in Accordance with the Least Burdensome Provisions of FDAMA” 

– “A Suggested Approach to Resolving Least Burdensome Issues”

• Congress updated the least burdensome provisions to clarify the least 

burdensome standard in the FDA Safety and Innovation Act of 2012

Background
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• Congress further clarified least burdensome in the 21st Century Cures 

Act of 2016 and expanded least burdensome, required training of FDA 

staff, and that the FDA document how least burdensome requirements 

are considered for significant decisions in substantive summaries

• The FDA issued final guidance, Developing and Responding to 

Deficiencies in Accordance with the Least Burdensome Provisions, on 

September 29, 2017 that updated the 2000 guidance on premarket 

deficiencies

• The FDA issued draft guidance, “The Least Burdensome Provisions: 

Concept and Principles” on December 15, 2017

• The Government Accountability Office published a report on December 

15, 2017 recommending that the FDA develop metrics to evaluate 

whether it consistently applies a least burdensome approach in 

reviews

Background
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• “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.” (section 513(i)(1)(D)(i) of the 

(FD&C Act)

• “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.” (section 513(a)(3)(D)(ii) 

of the FD&C Act)

• 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.” (section 515(c)(5)(A) of the FD&C Act)

Summary of Current 

Least Burdensome Provisions
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• “[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 

effectiveness.” (section 515(c)(5)(C) of the FD&C Act)

• 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. (sections 

513(a)(3)(D)(iii), 513(i)(1)(D)(ii), and 515(c)(5)(B) of the FD&C 

Act)

• The least burdensome provisions do not change the standards 

for premarket approval or substantial equivalence. (sections 

513(a)(3)(D)(iv), 513(i)(1)(D)(iii), and 515(c)(5)(D) of the FD&C 

Act)

Summary of Current 

Least Burdensome Provisions
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• The FDA received 79 comments from 13 external stakeholders:

• Device manufacturers

• Law firm

• Trade associations

• Academia and healthcare associations

• Individuals

• Most comments were supportive of CDRH proposal

• Revisions and additions requested regarding the least 

burdensome definition and guiding principles

• Request for inclusion of additional examples

• Stakeholders requested more information about 

implementation

Stakeholder Feedback on Draft 

Guidance
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The minimum amount of information 

necessary to adequately address a relevant 

regulatory question or issue through the most 

efficient manner at the right time

Definition of Least Burdensome
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• The least burdensome concept applies to all 

products that meet the definition of a device, 

including device constituent parts of combination 

products

• The policy in this guidance applies to all activities 

pertaining to the regulation of devices, including 

premarket and postmarket actions

• The policy maintains the FDA’s “gold standard”

Scope
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• The FDA has identified seven least burdensome 

guiding principles

• These guiding principles:

– Represent what the FDA and industry should 

apply when taking a least burdensome 

approach

– Explain the FDA’s commitment for least 

burdensome review

Guiding Principles
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1. The 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 the 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 the FDA

• Industry should reference applicable FDA guidance 

documents where FDA recommendations were 

considered

Guiding Principles
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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 Medical Device User 

Fee Amendments (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

Guiding Principles
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4. The right information should be provided at the right time 

(just-in-time data collection) to address the right questions

• The FDA intends to, and industry should, consider 

the use of postmarket data collection to reduce 

premarket data collection whenever appropriate and 

feasible

5. Regulatory approaches should be designed to fit the 

technology, taking into account its unique innovation 

cycles, evidence generation needs, and timely patient 

access

Guiding Principles
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6. The 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. The FDA intends to apply least burdensome principles in 

international medical device convergence and 

harmonization efforts

• The FDA intends to actively engage in the 

development, recognition, and use of voluntary 

consensus standards published by international and 

other standards development organizations

Guiding Principles
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• Final guidance includes examples to represent how least 

burdensome principles can be implemented

• These examples generally relate to:

– Different sources of and reducing the burden of clinical data

– Using nonclinical data

– Accepting alternative approaches

– Benefit-risk assessments

– Reducing administrative burden

– Smart regulation

– Global harmonization

– Balance premarket and postmarket

– The use of just-in-time testing

Applications of Least Burdensome
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• Leveraging existing data

– Peer reviewed literature has been used to as the pillar for:

• Marketing authorization in De Novo requests and 

humanitarian device exemption applications

• Support expanded indications for use and other labeling 

changes in 510(k) submissions

– Information filed in premarket approval applications was 

used to reclassify stair-climbing wheelchairs and sharps 

needle destruction devices under the six-year rule

Examples – Minimum Information 

Necessary
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• Reducing the burden of traditional clinical studies using 

historical control groups, non-comparative clinical outcome 

studies, subject as own control, adaptive study designs, and 

alternatives to prospective sample collection

• Global harmonization

– Voluntary consensus standards create consistent 

approaches to device development, manufacturing, and 

evaluation

– The Medical Device Single Audit Program minimizes the 

number of audits, redundant requests, and disruption of 

business, while still meeting the requirements of applicable 

jurisdictions

Examples – Most Efficient Means
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• Striking the right balance between Premarket and Postmarket

data collection

– The FDA assessed 200 product codes for Class III devices to 

consider whether these device types were candidates for a 

premarket/postmarket shift of data capture or reclassification. 

Three final orders to reclassify have been published thus far

• Just-in-time testing

– Device evaluation strategies can be used to transparently 

establish a timeline for deferred or additional nonclinical 

testing as a company proceeds through subsequent clinical 

studies

Examples – The Right Time
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• The FDA published the FDA Report to Congress: Least 

Burdensome Training Audit in June 2018

• Since the FDA Report to Congress, CDRH finished training 

all staff with a targeted course entitled “How to Make the 

Most of Least Burdensome: Case Study Practice”

• CDRH conducted a pilot on a new approach to resolving 

issues in 510(k) submissions called the least burdensome 

flag

Update on Implementation Efforts
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• The least burdensome flag is an opportunity for a submitter to 

request an informal review by upper management because they 

believe the FDA’s request is not least burdensome or that they 

are being held to an inappropriate review standard

• CDRH ran a least burdensome flag pilot from February -

September, 2018 in seven review Branches 

• 510(k) requests for additional information for applicable 

Branches that did not raise a potential not substantially 

equivalent (NSE) issue included an attachment offering the 

opportunity to use the least burdensome flag

Least Burdensome Flag Pilot
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• Submitters should discuss with Branch/Division 

management at least one time before being eligible

• Flag was limited to deficiency or deficiencies in two 

topics areas (e.g., biocompatibility and sterility)

• The least burdensome flag expires 60 days after the 

request for additional information was sent

• If used, least burdensome flag feedback is sent within 

21 days of receipt

Pilot Criteria
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• The FDA requested feedback from one third of submitters 

who did not use the flag and all submitters who used the 

flag

• Pilot sought to answer questions related to customer 

satisfaction, efficiency, and submission outcomes

• 132 letters received the least burdensome flag opportunity. 

Two (2) submitters used the flag (1.5%)

Summary of Pilot
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• The majority of respondents understood the purpose of the least 

burdensome flag, its process, and appreciated the opportunity to 

receive feedback from senior management

• Respondents did not use the flag because the issues were 

resolved either with the Branch Chief or a 10-day phone call, or 

the deficiencies were reasonable

• A few respondents thought the pilot was too restrictive or were 

concerned about using official meetings

• All respondents would use the least burdensome flag if they did 

not agree with the FDA’s request for additional information

Feedback from Expired Least 

Burdensome Flags
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• More likely to use the least burdensome flag over an 

appeal

• Timing of the least burdensome flag with a 10-day 

call, Submission Issue Meeting, or an appeal were not 

clear

• Prospectively understanding the depth of review 

would have helped

• 510(k) is the highest priority for this program, if made 

final

Feedback from Least Burdensome Flags
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• The least burdensome flag was used in 1.5% of 

submissions included in the pilot

• Flags were resolved in a straightforward manner 

within the 21-day deadline

• Limiting the least burdensome flag to two topic areas 

made resolution efficient

• Submitters appreciated the opportunity to obtain 

senior management feedback

Summary of Pilot Data
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• The pilot results support that the least burdensome 

flag is simpler than an appeal, is a useful process for 

our staff, and provided preliminary results that our 

staff are least burdensome. Industry believed that the 

least burdensome flag provided a valuable opportunity 

to raise concerns about their submissions

• CDRH is implementing the least burdensome flag as a 

program for 510(k) submissions to act as a 

performance metric for the implementation of least 

burdensome requirements. 

Pilot Conclusions and Next Steps
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• CDRH implemented the least burdensome flag on March 4, 2019 

for all 510(k) requests for additional information that are not 

potential not substantially equivalent decisions

• Before using flag, submitters should discuss concerns with the 

signatory authority or their manager

• Least burdensome flags should be within two topic areas. If 

more than two topic areas, contact the 510(k) Staff

• Flags should be used within 60 days of the letter or they expire. 

Flags do not change response due date for the submitter

Least Burdensome Flag Program
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Email the lead reviewer, their manager, and the 510(k) Staff with 

the following information (1-2 pages):

• A summary of the deficiencies being flagged, including why the 

request is not least burdensome or the submitter is being held to 

a different standard

• A summary of relevant communications with the signatory 

authority or their manager to show that the submitter has sought 

management input before “throwing the flag”

• Proposed path forward

How to use the Least Burdensome Flag
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• The FDA will hold an internal meeting(s) and only schedule 

a teleconference with the submitter if they could not 

resolve the least burdensome flag internally

• The least burdensome flag response will be emailed on 

behalf of the Director of the organizational unit in CDRH 

responsible for your 510(k)

• The least burdensome flag resolution is included in the 

administrative record

What Submitters Should Expect
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Link to final least burdensome guidance:

• The Least Burdensome Provisions: Concept and Principles

Selected links:

• Developing and Responding to Deficiencies in Accordance 

with the Least Burdensome Provisions

• FDA Report to Congress: Least Burdensome Training 

Audit

• Government Accountability Office report on least 

burdensome medical device reviews

Resources
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Questions?

510(k) Questions: 510K_Program@fda.hhs.gov

Division of Industry and Consumer Education: DICE@fda.hhs.gov

Slide Presentation, Transcript and Webinar Recording 

will be available at: http://www.fda.gov/training/cdrhlearn Under the heading: How 

to Study and Market Your Device; Subheading: Cross-Cutting Premarket Policy

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