Contains Nonbinding Recommendations 
Intent to Exempt Certain Unclassified 
Medical Devices from Premarket 
Notification Requirements 
Guidance for Industry and 
Food and Drug Administration Staff 
Document issued on February 8, 2019. 
Document originally issued on July 1, 2015. 
This document updates and supersedes Intent to Exempt Certain 
Unclassified from Premarket Notification Requirements, issued 
  August 14, 2015. 
This guidance was updated on June 14, 2019 to remove product codes 
previously inadvertently included, which were already exempt from 
premarket notification requirements. 
For questions about this document, contact Regulations, Policy, and Guidance Staff by email at 
RPG@fda.hhs.gov. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health  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 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-2014-D-0967. Comments may not be acted 
upon by the Agency until the document is next revised or updated. 
Additional Copies 
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 1300046 to identify the guidance you are requesting.  Contains Nonbinding Recommendations 
Table of Contents 
I.  Introduction ............................................................................................................................................ 1 
II.  Background ............................................................................................................................................ 1 
III.  Scope ...................................................................................................................................................... 2 
IV.  Unclassified Devices FDA Intends to Exempt from Premarket Notification Requirements .................. 2 
A.  Ear, Nose, and Throat Devices ............................................................................................................... 2 
B.  Gastroenterology-Urology Devices ........................................................................................................ 2 
C.  General and Plastic Surgical Devices ..................................................................................................... 2 
D.  Obstetrical and Gynecological Devices ................................................................................................. 3 
E.  Physical Medicine Devices .................................................................................................................... 3  Contains Nonbinding Recommendations 
Intent to Exempt Certain Unclassified 
Medical Devices from Premarket 
Notification Requirements 
Guidance for Industry and Food and 
Drug Administration Staff 
This guidance represents the current thinking of Food and Drug Administration (FDA) 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 
responsible for this guidance listed on the title page. 
I.  Introduction 
This guidance describes the Food and Drug Administrations (FDAs) intent to exempt certain 
unclassified medical devices from premarket notification requirements. FDA believes devices 
identified in Section IV of this guidance document are sufficiently well understood and do not 
require premarket notification (510(k)) to assure their safety and effectiveness. Until the 
publication of a final rule exempting these devices from 510(k), FDA does not intend to enforce 
compliance with 510(k) requirements for these devices. FDA does not expect manufacturers to 
submit 510(k)s for these devices during this time period. 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agency's 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 guidances means that something is suggested or 
recommended, but not required. 
II.  Background 
In the commitment letter (section 1.G of the Performance Goals and Procedures) 
(https://www.fda.gov/media/83244/download) that was drafted as part of the reauthorization 
process for the Medical Device User Fee Amendments of 2012, FDA committed to identifying 
low-risk medical devices to exempt from premarket notification requirements. Under the 21st 
Century Cures Act, FDA was given the authority to exempt class II and class I reserved medical 
devices from premarket notification requirements on a periodic basis.  To date, several class I 
1  Contains Nonbinding Recommendations 
and class II devices have been exempted through 510(l)1 and 510(m)2, respectively, of the 
Federal Food, Drug, and Cosmetic Act as amended.  Therefore, for the purposes of this 
guidance, FDA has identified certain unclassified medical devices (that FDA intends to classify 
into class I or II) for which FDA believes premarket notification is not necessary to assure safety 
and effectiveness before these devices enter the marketplace. 
III.  Scope 
The goal of this document is to outline FDAs intent to propose exempting the unclassified 
medical devices listed below in Section IV from premarket notification requirements. FDA does 
not intend to exempt these devices from other statutory and regulatory requirements, including, 
but not limited to: registration and listing (21 CFR part 807); labeling (21 CFR part 801); good 
manufacturing practice requirements as set forth in the Quality System regulation (21 CFR part 
820); and Medical Device Reporting requirements (21 CFR part 803). It is not FDAs intent to 
exempt any combination products that may fall within the product codes subject to this guidance. 
Also, single-entity products containing an antimicrobial agent are not within the scope of this 
guidance. 
IV.  Unclassified Devices FDA Intends to Exempt from 
Premarket Notification Requirements 
A.  Ear, Nose, and Throat Devices 
Preamendment unclassified devices  FDA intends to exempt the following product codes: 
EWD  Protector, Hearing (Insert) 
EWE  Protector, Hearing (Circumaural) 
LEZ  Aids, Speech Training for the Hearing Impaired (AC-Powered and Patient-
Contact) 
LFA  Aids, Speech Training for the Hearing Impaired (Battery-Operated or Non-
Patient) 
B.  Gastroenterology-Urology Devices 
Preamendment unclassified device  FDA intends to exempt the following product code: 
LRL  Cushion, Hemorrhoid 
C.  General and Plastic Surgical Devices 
Preamendment unclassified device  FDA intends to exempt the following product code: 
LKB  Pad, Alcohol, Device Disinfectant 
                                                          
1 82 FR 17841 
2 82 FR 31976 and 83 FR 25910 
2 Contains Nonbinding Recommendations 
D.  Obstetrical and Gynecological Devices 
Preamendment unclassified devices  FDA intends to exempt the following product code: 
LHD  Device, Fertility Diagnostic, Proceptive 
E.  Physical Medicine Devices 
Preamendment unclassified devices  FDA intends to exempt the following product code: 
LZW  Monitor, Spine Curvature 
3