Contains Nonbinding Recommendations 
The Abbreviated 510(k) Program
 
Guidance for Industry and 
Food and Drug Administration Staff 
Document issued on September 13, 2019. 
This document supersedes the Abbreviated 510(k) content from The New 
510(k) Paradigm - Alternate Approaches to Demonstrating Substantial 
Equivalence in Premarket Notifications issued March 20, 1998. 
For questions about this document, contact ORP: Office of Regulatory Programs, DRP1: 
Division of Submission Support, Premarket Notification and Classification Team at 
510K_Program@fda.hhs.gov or 301-796-5640. 
For questions about this document regarding CBER-regulated devices, contact the Office of 
Communication, Outreach, and Development (OCOD) at 800-835-4709 or 240-402-8010. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Center for Biologics Evaluation and Research 
1  Contains Nonbinding Recommendations 
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-2019-D-4015. 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 include the 
document number 905 and complete title of the guidance in the request. 
CBER 
Additional copies are available from the Center for Biologics Evaluation and Research 
(CBER), Office of Communication, Outreach, and Development (OCOD), 10903 New 
Hampshire Ave., WO71, Room 3128, Silver Spring, MD 20903, or by calling 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. 
2 Contains Nonbinding Recommendations 
The Abbreviated 510(k) Program 
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 
This guidance provides recommendations on an optional approach that may be used to 
demonstrate substantial equivalence in premarket notifications (510(k)s). The Abbreviated 
510(k) Program uses guidance documents, special controls, and/or voluntary consensus 
standards to facilitate FDAs premarket review of 510(k) submissions. The alternative 
approach described in this guidance document is intended to facilitate 510(k) submission 
preparation by manufacturers and review by FDA. FDA believes this voluntary program may 
conserve industry and Agency resources, while still protecting the public health, and not 
altering the statutory criteria for substantial equivalence. 
For the current edition of the FDA-recognized standard(s), see the FDA Recognized 
Consensus Standards Database.1 For more information regarding use of consensus standards 
in regulatory submissions, please refer to the FDA guidance document titled Appropriate 
Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices2 and 
Standards Development and the Use of Standards in Regulatory Submissions Reviewed in 
CBER.3
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. 
                                                
1 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. 
2 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-
consensus-standards-premarket-submissions-medical-devices. 
3 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/standards-development-and-use-
standards-regulatory-submissions-reviewed-center-biologics-evaluation. 
3 Contains Nonbinding Recommendations 
II.  Background 
Under section 510(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), each person 
required to register with FDA and who proposes to introduce a device into interstate 
commerce for commercial distribution is required to submit a 510(k) to FDA at least 90 days 
before commercial distribution is to begin. FDA established the Abbreviated 510(k) Program 
in 1998 and described the program and policy in the guidance document The New 510(k) 
Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket 
Notifications. The Abbreviated 510(k) Program was intended to create an efficient 
submission preparation and review process that relies on guidance documents, special 
controls, and/or voluntary consensus standards. The Abbreviated 510(k) Program does not 
alter any statutory or regulatory requirements related to the premarket notification process 
under sections 510 and 513 of the FD&C Act, and 21 CFR 807 subpart E. 
This guidance document supplements other FDA guidances regarding the specific content 
requirements and recommendations of a 510(k) submission. You should also refer to 21 CFR 
807.87 and FDAs guidances Refuse to Accept Policy for 510(k)s4 and Format for 
Traditional and Abbreviated 510(k)s.5
III.  The Abbreviated 510(k) Program 
FDA issues guidance documents to communicate the Agencys recommendations to industry. 
FDA believes that, within the Abbreviated 510(k) Program, the use of guidance documents may 
facilitate the review of 510(k)s through a reliance on a summary reports that briefly 
describe and summarize the testing performed to support the submission as recommended in 
relevant guidance document(s). These reports summarize the device description, the 
manufacturers device design requirements, risk management information, and a description 
of test methods used to address performance characteristics. A 510(k) submission that 
addresses the recommendations of an FDA guidance document should be easier to prepare by 
manufacturers and for FDA to review. 
The Safe Medical Devices Act of 1990 (Public Law 101-629) introduced the concept of 
special controls to provide a reasonable assurance of safety and effectiveness for class II 
devices. Special controls are defined in section 513(a)(1)(B) of the FD&C Act as those 
controls, such as performance standards, postmarket surveillance, patient registries, 
development and dissemination of guidelines, recommendations and other appropriate 
actions that provide reasonable assurance of the device's safety and effectiveness. As in the 
case of guidance documents, summary information that describes how a special control(s) 
has been used to address a specific risk or issue should reduce the time and effort to prepare 
and review 510(k)s. 
                                                
4 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks. 
5 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-and-
abbreviated-510ks. 
4 Contains Nonbinding Recommendations 
In addition to guidance documents and special controls, the appropriate use of voluntary 
consensus standards can increase predictability of the premarket review process, provide 
clearer regulatory expectations, and facilitate market entry of safe and effective medical 
products. Section 204 of the FDA Modernization Act of 1997 (FDAMA, Public Law 105-
115) introduced voluntary consensus standards into section 514(c) of the FD&C Act. 
FDAMA also introduced changes to the 510(k) Program, such as increased reliance on 
postmarket controls to expedite device classification under section 205 of FDAMA (section 
513(i)(1)(C) of the FD&C Act). 
Therefore, device manufacturers may choose to submit an Abbreviated 510(k) when the 
submission relies on one or more: 
  FDA guidance document(s); 
  Demonstration of compliance with special controls for the device type, either in a 
device-specific classification regulation or a special controls guidance document; and/or 
  Voluntary consensus standard(s). 
An Abbreviated 510(k) submission must include the required information identified in 21 CFR 
807.87. In addition, manufacturers submitting an Abbreviated 510(k) that relies on an FDA 
guidance document and/or special control(s) should include a summary report that describes 
how the guidance document(s) were used to demonstrate substantial equivalence and/or how 
the device complies with special control(s). If recommendations in guidance document(s) are 
used to support substantial equivalence, the summary report should include information 
regarding any deviations, that is any alternative methods used to demonstrate substantial 
equivalence that are not described in the guidance. For more information about summary 
reports, see Appendix A. 
Manufacturers submitting an Abbreviated 510(k) that relies on a voluntary consensus 
standard(s) should provide the information described in Appendix A and a declaration of 
conformity as recommended by the guidance document Appropriate Use of Voluntary 
Consensus Standards in Premarket Submissions for Medical Devices.6 Manufacturers 
submitting an Abbreviated 510(k) that relies on general use of a voluntary consensus 
standard should include the basis of such use along with the underlying information or data 
that supports how the standard was used. 
The incentive for manufacturers to provide summary reports describing the use of guidance 
documents, special controls, or the appropriate use of voluntary consensus standards is 
intended to facilitate 510(k) submission preparation of 510(k) submissions. FDA believes that 
its review of Abbreviated 510(k)s may be more efficient than that of Traditional 510(k) 
submissions. In addition, by allowing FDA staff to rely on a manufacturers summary report 
on the use of an FDA guidance document(s), special control(s), and/or voluntary consensus 
standard(s), FDAs review resources can be used in an efficient manner. 
                                                
6 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-
consensus-standards-premarket-submissions-medical-devices. 
5 Contains Nonbinding Recommendations 
Subject to FDAs acceptance review in accordance with the guidance Refuse to Accept 
Policy for 510(k)s,7 FDA intends to review Abbreviated 510(k) submissions within FDAs 
90-day statutory deadline under section 510(n)(1) of the FD&C Act and Medical Device 
User Fee Amendments (MDUFA) performance goals for 510(k) submissions. If a 
manufacturer submits an Abbreviated 510(k) that FDA does not believe is appropriate for 
review under the Abbreviated 510(k) Program, FDA intends to convert the submission to a 
Traditional 510(k) and notify the submitter. 
                                                
7 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks. 
6 Contains Nonbinding Recommendations 
Appendix A.  Abbreviated 510(k) Content 
An Abbreviated 510(k) should include: 
  A coversheet clearly identifying the submission as an Abbreviated 510(k); 
  Information required under 21 CFR 807.87, including a description of the 
device, the intended use and the indications for use of the device,8 and the 
proposed labeling for the device. For further information about the 
suggested format and content of an Abbreviated 510(k), see the FDA 
guidance Refuse to Accept Policy for 510(k)s9 and Format for 
Traditional and Abbreviated 510(k)s.10
  For a submission that relies on an FDA guidance document(s) or is subject 
to special controls, a summary report that describes how the guidance(s) 
were used to demonstrate substantial equivalence and/or how the device 
complies with the special control(s). These reports summarize the device 
description, the manufacturers device design requirements, risk 
management information, and a description of test methods used to 
address performance characteristics. If a manufacturer chooses to use an 
alternative approach to address a particular issue, sufficient detail should 
be provided to justify that approach; 
  For a submission that relies on voluntary consensus standards, we 
recommend that you consult the FDA guidance Appropriate Use of 
Voluntary Consensus Standards in Premarket Submissions for Medical 
Devices;11
  Data/information to address issues not covered by guidance documents, 
special controls, and/or voluntary consensus standards; and 
  Indications for Use form (FDA Form 388112). 
                                                
8 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-
substantial-equivalence-premarket-notifications-510k. 
9 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks. 
10 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-and-
abbreviated-510ks. 
11 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-
consensus-standards-premarket-submissions-medical-devices. 
12 https://www.fda.gov/media/86323/download. 
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