Information Sheet Guidance For 
IRBs, Clinical Investigators, and 
Sponsors 
 
Significant Risk and Nonsignificant Risk 
Medical Device Studies  
 
  
Additional copies are available from: 
 
Office of Good Clinical Practice 
Office of Special Medical Programs, Office of the Commissioner 
Food and Drug Administration 
10903 New Hampshire Ave., WO32-5129 
Silver Spring, MD 20993-5129 
(Tel) (301)-796-8340 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf    
 
or 
 
Division of Small Manufacturers, International, and Consumer Assistance 
Office of Communication, Education and Radiation Programs 
Center for Devices and Radiological Health 
Food and Drug Administration 
10903 New Hampshire Ave., WO66-4521 
Silver Spring, MD 20993 
Tel: 1-800-638-2041 or 301-796-7100 
dsmica@fda.hhs.gov 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health (CDRH) 
 
January 2006 
  Contains Nonbinding Recommendations 
 
 
 
TABLE OF CONTENTS 
 
I.  INTRODUCTION.............................................................................................................2 
II.  BACKGROUND...............................................................................................................2 
III.  SIGNIFICANT RISK AND NONSIGNIFICANT RISK DEVICE STUDIES...........3 
A.  What is a Significant Risk Device Study?....................................................................................3 
B.  What is a Nonsignificant Risk Device Study?.............................................................................3 
C.  Who Decides Whether a Device Study is SR or NSR?...............................................................3 
D.  What are the Major Differences Between SR and NSR Device Studies?.................................4 
IV.  WHAT ARE THE SPONSOR'S RESPONSIBILITIES WHEN INITIATING A 
DEVICE STUDY?........................................................................................................................4 
A.  For Nonsignificant Risk Device Studies.......................................................................................4 
B.  For Significant Risk Device Studies.............................................................................................5 
V.  WHAT ARE THE IRB'S RESPONSIBILITIES WHEN IT RECEIVES A DEVICE 
STUDY FOR REVIEW?..............................................................................................................5 
VI.  WHAT SHOULD IRBS CONSIDER WHEN MAKING THE SR AND NSR 
DETERMINATION?...................................................................................................................6 
VII.  HOW DOES AN IRB DOCUMENT THE SR OR NSR DETERMINATION?.........7 
VIII.  WHAT SHOULD AN IRB DO FOR DEVICE STUDIES THAT ARE EXEMPT 
FROM THE REQUIREMENTS OF THE IDE REGULATIONS (21 CFR 812.2(C))?......7 
A.  Difference Between NSR and Minimal Risk Determinations....................................................8 
B.  Difference Between SR/NSR Determinations and Approval Decisions....................................8 
IX.  WHAT ARE FDA'S RESPONSIBILITIES?.................................................................8 
X.  EXAMPLES OF  NSR AND SR DEVICES...................................................................8 
A.  Nonsignificant Risk Devices..........................................................................................................9 
B. Significant  Risk Devices..............................................................................................................10  
 
1  Contains Nonbinding Recommendations 
 
 
 
 
Information Sheet Guidance 
1
 For IRBs, Clinical Investigators, and Sponsors
Significant Risk and Nonsignificant Risk Medical Device Studies 
 
 
 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic.  It 
does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  
You can use an alternative approach if it satisfies the requirements of the applicable statutes and 
regulations.  If you want to discuss an alternative approach, contact the FDA staff responsible for 
implementing this guidance.  If you cannot identify the appropriate FDA staff, call the appropriate 
number listed on the title page of this guidance. 
 
 
 
I. INTRODUCTION 
 
This guidance is intended to provide advice to sponsors, clinical investigators, and institutional 
review boards (IRBs) on how to determine the differences between significant risk and 
nonsignificant risk medical device studies.  This document supersedes Significant Risk and 
Nonsignificant Risk Medical Device Studies (September 1998) Office of Health Affairs, Food 
and Drug Administration.  This document was revised to update the list of examples of 
significant and nonsignificant risk devices, to clarify the IRBs responsibilities when making the 
risk determination for investigational medical devices, and to make the guidance consistent with 
the Agencys good guidance practices regulations (21 CFR 10.115). 
 
FDA's 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 
 
                                                 
1 This guidance document was developed by the Good Clinical Practice Program in coordination with the Agency 
Centers.  
 
 
2  Contains Nonbinding Recommendations 
  
  
  
The Investigational Device Exemptions (IDE) regulation (21 CFR 812) describes three types of 
device studies: significant risk (SR), nonsignificant risk (NSR), and exempt studies.  In this 
guidance, we discuss the two types of studies that are subject to the IDE regulation  the SR and 
NSR studies.  For information on studies that are exempt from the IDE regulation, see the 
Information Sheet Guidance entitled, Frequently Asked Questions About Medical Devices.     
III.  SIGNIFICANT RISK AND NON-SIGNIFICANT RISK DEVICE STUDIES 
  
  
A.  What is a Significant Risk Device Study? 
  
Under 21 CFR 812.3(m), an SR device means an investigational device that: 
  
  Is intended as an implant and presents a potential for serious risk to the health, safety, or 
welfare of a subject; 
  Is purported or represented to be for use supporting or sustaining human life and presents a 
potential for serious risk to the health, safety, or welfare of a subject; 
  Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, 
or otherwise preventing impairment of human health and presents a potential for serious risk 
to the health, safety, or welfare of a subject; or 
  Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.    
B.  What is a Nonsignificant Risk Device Study? 
  
  
An NSR device study is one that does not meet the definition for an SR device study.  
  
C.  Who Decides Whether A Device Study is SR or NSR? 
  
Sponsors are responsible for making the initial risk determination and presenting it to the IRB.  
FDA is also available to help the sponsor, clinical investigator, and IRB in making the risk 
determination.2 
  
Unless FDA has already made a risk determination for the study, the IRB must review the 
sponsor's SR or NSR determination for every investigational medical device study reviewed and 
modify the determination if the IRB disagrees with the sponsor.  If FDA has already made the 
SR or NSR determination for the study, the agency's determination is final.  FDA is available to 
help the IRB when making its risk determination.  (Also, see section VII. How does an IRB 
document the SR or NSR determination?) 
  
                                                  
 See the guidance entitled, Procedures for Handling Inquiries Regarding the Need for an Investigational Device 
2
Exemptions Application for Research Involving Medical Devices.  This guidance may be found at: 
www.fda.gov/MedicalDevices/DeviceRegulatonandGuidance/GuidanceDocuments/ucm126598. 
3   Contains Nonbinding Recommendations 
 
 
 
FDA is the final arbiter as to whether a device study is SR or NSR and makes the determination 
when an IDE is submitted to FDA or if asked by the sponsor, clinical investigator, or IRB.  See 
21 CFR  812.2(b)(1) 
 
D.  What are the Major Differences Between SR And NSR Device Studies? 
 
The major differences between SR and NSR studies are in the IDE approval process and in the 
sponsors record keeping and reporting requirements, as outlined below.  
 
1. Significant  Risk (SR) Device Studies 
 
  SR device studies must follow all the IDE regulations at 21 CFR 812.   
 
  SR device studies must have an IDE application approved by FDA before they may proceed.  
 
2.  Nonsignificant Risk (NSR) Device Studies 
 
  NSR device studies must follow the abbreviated requirements at 21 CFR 812.2(b). 
 
  These abbreviated requirements address labeling, IRB approval, informed consent, 
monitoring, records, reports, and prohibition against promotion.  However, there is no need 
to make progress reports or final reports to FDA. 
 
  NSR device studies do not have to have an IDE application approved by FDA.  
 
  Sponsors and IRBs do not have to report the IRB approval of an NSR device study to FDA.  
This means that an IRB may approve an NSR device study and an investigator may conduct 
the study without FDA knowing about it.   
 
  An IRBs NSR determination is important because the IRB serves as the FDAs surrogate for 
review, approval, and continuing review of the NSR device studies.  An NSR device study 
may start at the institution as soon as the IRB reviews and approves the study and without 
prior approval by FDA. 
 
IV.  WHAT ARE THE SPONSOR'S RESPONSIBILITIES WHEN INITIATING A   
DEVICE STUDY? 
 
A.  For Nonsignificant Risk Device Studies 
 
  If the sponsor identifies a study as NSR, the sponsor must provide the reviewing IRB an 
explanation of its determination (21 CFR 812.2(b)(1)(ii)) and should provide any other 
information that may help the IRB in evaluating the risk of the study.  For example, a 
4  Contains Nonbinding Recommendations 
 
 
 
description of the device, reports of prior investigations with the device, the proposed 
investigational plan, subject selection criteria, and other information the IRB may need.   
 
  If FDA has determined that the study is NSR, the sponsor should so inform the IRB. 
By providing such risk determination information to the IRB, the IRBs workload should be 
reduced and the review process should be facilitated.   
 
B.  For Significant Risk Device Studies 
 
  The sponsor must submit an IDE application to FDA and obtain the agencys approval of the 
study.   (See 21 CFR 812.20(a)(1) and (2)) 
 
  The sponsor must advise its clinical investigators about the SR status and obtain their 
agreement to comply with the applicable regulations governing such studies (i.e., 21 CFR 
Parts, 50, 56, 812)  (See 21 CFR 812.43(c)(4)(i)).  Sponsors should provide the IDE number 
and/or a copy of the IDE approval letter to the IRB when requested. 
 
  Sponsors may send their SR device study to an IRB for review before the IDE application is 
approved by FDA.  However, FDA cautions that an SR device study may not begin until 
FDA approves the IDE. 
 
V.  WHAT ARE THE IRBS RESPONSIBILITIES WHEN IT RECEIVES A DEVICE 
STUDY FOR REVIEW? 
 
  IRBs should have standard operating procedures that explain how the IRB makes SR and 
NSR determinations and that the decision should be documented.  FDA considers this 
determination to be part of the IRBs responsibilities for conducting its initial review of a 
study.  (See 21 CFR 56.108)  
 
  IRBs should make the SR or NSR determination about a study by reviewing relevant 
information at a convened meeting.  This information includes the description of the device, 
reports of prior investigations conducted with the device, the proposed investigational plan, 
and subject selection criteria.  The sponsor should provide the IRB with a risk assessment 
and the rationale used in making its SR or NSR determination.   
 
  An IRB may agree or disagree with the sponsors initial NSR assessment. 
   
  If the IRB determines the study is NSR, the IRB may approve the study using the criteria at 
21 CFR 56.111.  The study may begin without submission of an IDE application to FDA.   
 
  If the IRB disagrees with the sponsors NSR assessment and decides the study is SR, the IRB 
must tell the clinical investigator, and where appropriate, the sponsor.  (See 21 CFR 812.66) 
5  Contains Nonbinding Recommendations 
 
 
 
 
  An IRB may approve the study as an SR device study, but the study may not begin until FDA 
approves the sponsors IDE application.  
 
  To facilitate the IRBs review of the study, an IRB may ask the sponsor for proof (i.e., a copy 
of FDAs approval or conditional approval letter) that an SR study has an FDA-approved 
IDE application. 
 
  The IRB should document its SR/NSR determination in the IRB meeting minutes.  
 
VI.  WHAT SHOULD IRBS CONSIDER WHEN MAKING THE SR AND NSR  
DETERMINATION? 
 
  What is the basis for the risk determination? The risk determination is based on the proposed 
use of a device in an investigation, and not on the device alone.   
 
  What is the nature of harm that may result from use of the device?  SR studies are those that 
present a potential for serious risk to the health, safety, or welfare of a subject.  See the 
question What is a Significant Risk Device Study? for further information.  
 
  Will the subject need to undergo an additional procedure as part of the investigational study, 
for example, a surgical procedure?  IRBs should consider the potential harm the procedure 
could cause as well as the potential harm caused by the device.  Several examples follow: 
 
1.  The study of a change to a commercially available pacemaker (e.g., new leads, 
battery pack, or software) poses an SR because the device is used to support or 
sustain human life and it presents a potential for serious harm to the subjects. This is 
true even though the changed pacemaker may potentially pose less risk, or only 
slightly greater risk, in comparison to the commercially available model.  
2.  The study of an extended wear contact lens is SR because wearing the lens 
continuously overnight while sleeping presents a potential for injuries not normally 
seen with daily wear lenses, which are NSR. 
3.  An investigational study of a sensor pad to find out if the device can detect the 
electrical activity of the spinal cord may be NSR, if the study of the sensor pad takes 
place at the same time as the planned surgical repair of the spinal cord, if all the 
following are true:  
 
-  repair of the spinal cord would occur anyway;  
6  Contains Nonbinding Recommendations 
 
 
 
-  the sensor pad does not present a potential for serious risk to the health, safety, or 
welfare of a subject (for example, placing the pad would not prolong or interfere 
with the operation);  
-  the sensor pad is not implanted;  
-  the pad is not of substantial importance in diagnosing, curing, mitigating or 
treating disease. 
 
VII.  HOW DOES AN IRB DOCUMENT THE SR OR NSR DETERMINATION? 
 
The IRB should write its decision in the meeting minutes.  The minutes should describe the 
IRBs reason for its SR or NSR determination and may also include the documentation used to 
establish the IDE status for the study.  For an SR determination, such documentation may 
include, for example, a copy of the IDE approval or conditional approval letter from FDA.  For 
an NSR determination, the documentation may include FDA's NSR determination where the 
agency has made the determination.  FDA will issue an NSR letter upon written request. 
 
VIII.   WHAT SHOULD AN IRB DO FOR DEVICE STUDIES THAT ARE EXEMPT 
FROM THE REQUIREMENTS OF THE IDE REGULATIONS (21 CFR 
812.2(C))? 
 
For studies that are exempt from the IDE regulations, the IRB does not need to decide whether 
the study poses a significant risk or nonsignificant risk.  However, the IRB must still review the 
study in accordance with the IRB regulations before the investigation may begin. 
 
IRBs should understand distinctions between certain important concepts that are frequently 
confused: 
 
A.  Difference between NSR and Minimal Risk Determinations 
 
IRBs should not confuse their responsibility to make an SR/NSR determination for a device 
study with the concept of minimal risk. Minimal Risk is a term used in the IRB 
regulations in part to identify certain studies that IRBs may approve through an expedited 
review procedure.  For a device study to be eligible for expedited review, it must be an NSR 
study AND present no more than minimal risk to the subject. (See 21 CFR 56.110)  
 
B. Difference  Between SR/NSR Determinations and Approval Decisions 
 
IRBs should not confuse their responsibility to review and approve research for conduct at a 
clinical site with the SR/NSR determination.  IRBs make the SR/NSR determination before 
the IRB conducts its review of the study under Part 56.  The judgment about whether a study 
poses a significant risk or nonsignificant risk is based on the significance of the potential 
harm that may result from participation in the study, including the use of the device; whereas 
7  Contains Nonbinding Recommendations 
 
 
 
the IRBs decision to approve a study for implementation is based on the studys risk-benefit 
assessment.   
 
IX.  WHAT ARE FDAS RESPONSIBILITIES? 
 
  As discussed, FDA is the final arbiter in deciding whether a device study poses a significant 
or nonsignificant risk.  It should be noted, however, that FDA generally only sees those 
studies that sponsors submit to the agency or those studies for which an IRB or clinical 
investigator asks for FDAs opinion. 
 
  If FDA disagrees with an IRBs NSR decision and determines that the study poses a 
significant risk, the sponsor may not begin their study until FDA approves an IDE.  (See 21 
CFR 812.42) 
 
  If a sponsor submits an IDE to FDA because the sponsor presumed it to be an SR study, and 
FDA determines that the device study poses a nonsignificant risk, FDA will tell the sponsor 
in writing.  The study may then be reviewed by the IRB as an NSR study. 
 
X.  EXAMPLES OF NSR AND SR DEVICES  
 
The following examples may help sponsors and IRBs in making SR and NSR determinations. 
The list includes many commonly studied medical devices.  Inclusion of a device in the NSR list 
is not a final determination because the evaluation of risk must reflect the proposed use of a 
device in a study.    
 
A.  Nonsignificant Risk Devices 
 
  Caries Removal Solution 
  Contact Lens Solutions intended for use directly in the eye (e.g., lubricating/rewetting 
solutions) using active ingredients or preservation systems with a history of prior 
ophthalmic/contact lens use or generally recognized as safe for ophthalmic use 
  Conventional Gastroenterology and Urology Endoscopes and/or Accessories 
  Conventional General Hospital Catheters (long-term percutaneous, implanted, subcutaneous 
and intravascular) 
  Conventional Implantable Vascular Access Devices (Ports)  
  Conventional Laparoscopes, Culdoscopes, and Hysteroscopes 
  Daily Wear Contact Lenses and Associated Lens Care Products not intended for use directly 
in the eye (e.g., cleaners; disinfecting, rinsing and storage solutions)  
  Dental Filling Materials, Cushions or Pads made from traditional materials and designs  
  Denture Repair Kits and Realigners 
  Digital Mammography 
8  Contains Nonbinding Recommendations 
 
 
 
  Electroencephalography (e.g., new recording and analysis methods, enhanced diagnostic 
capabilities, measuring depth of anesthesia if anesthetic administration is not based on device 
output) 
  Externally Worn Monitors for Insulin Reactions 
  Functional Non-Invasive Electrical Neuromuscular Stimulators 
  General Biliary Catheters 
  General Urological Catheters (e.g., Foley and diagnostic catheters) for short term use (< 28 
days) 
  Jaundice Monitors for Infants  
  Low Power Lasers for treatment of pain 
  Magnetic Resonance Imaging (MRI) Devices within FDA specified parameters  
  Manual Image Guided Surgery 
  Menstrual Pads (Cotton or Rayon, only) 
  Menstrual Tampons (Cotton or Rayon, only) 
  Nonimplantable Electrical Incontinence Devices  
  Nonimplantable Male Reproductive Aids with no components that enter the vagina 
  Ob/Gyn Diagnostic Ultrasound within FDA approved parameters 
  Partial Ossicular Replacement Prosthesis (PORP) 
  Total Ossicular Replacement Prosthesis (TORP) 
  Transcutaneous Electric Nerve Stimulation (TENS) Devices for treatment of pain (except for 
chest pain/angina) 
  Ureteral Stents 
  Urethral Occlusion Device for less than 14 days 
  Wound Dressings, excluding absorbable hemostatic devices and dressings (also excluding 
Interactive Wound and Burn Dressings that aid or are intended to aid in the healing process) 
 
B. Significan t Risk Devices 
 
1.  General Medical Use  
  Catheters for General Hospital Use - except for conventional long-term percutaneous, 
implanted, subcutaneous and intravascular 
  Collagen Implant Material for use in ear, nose and throat, orthopedics, plastic surgery, 
urological and dental applications 
  Surgical Lasers for use in various medical specialties 
  Tissue Adhesives for use in neurosurgery, gastroenterology, ophthalmology, general and 
plastic surgery, and cardiology  
 
2. Anesthesiology   
  Breathing Gas Mixers 
  Bronchial Tubes 
9  Contains Nonbinding Recommendations 
 
 
 
  Electroanesthesia Apparatus 
  Epidural and Spinal Catheters 
  Epidural and Spinal Needles 
  Esophageal Obturators 
  Gas Machines for anesthesia or analgesia 
  High Frequency Ventilators greater than 150 BPM 
  Rebreathing Devices 
  Respiratory Ventilators and new modes of ventilation 
  Tracheal Tubes  
 
3. Cardiovascular   
  Annuloplasty Rings 
  Aortic and Mitral Valvuloplasty Catheters 
  Arterial Embolization Devices 
  Atherectomy and Thrombectomy Catheters 
  Cardiac Assist Devices: artificial hearts, ventricular assist devices, intra-aortic balloon 
pumps, cardiomyoplasty devices 
  Cardiac Bypass Devices:  oxygenators, cardiopulmonary blood pumps, axial flow pumps, 
closed chest devices (except Class I cardiovascular surgical instruments), heat exchangers, 
catheters/cannulae, tubing, arterial filters, reservoirs 
  Cardiac Mapping and Ablation Catheters 
  Cardiac Pacemaker/Pulse Generators:  antitachycardia, esophageal, external transcutaneous, 
implantable 
  Cardiopulmonary Resuscitation (CPR) Devices 
  Cardiovascular Intravascular (vena cava) Filters 
  Coronary Artery Retroperfusion Systems 
  Distal Embolic Protection Devices 
  Extracorporeal Counterpulsation Devices 
  Extracorporeal Membrane Oxygenators (ECMO) 
  Implantable Cardioverters/Defibrillators 
  Intravascular Brachytherapy Devices 
  Intravascular Stents 
  Laser Angioplasty Catheters 
  Organ Storage/Transport Units 
  Pacing Leads 
  Percutaneous Conduction Tissue Ablation Electrodes 
  Percutaneous Transluminal Angioplasty Catheters 
  Replacement Heart Valves 
  Transcatheter Cardiac Occluders for atrial and ventricular septal defects, patent foramen 
ovale and patent ductus arteriosus 
1 0 Contains Nonbinding Recommendations 
 
 
 
  Transmyocardial Revascularization, Percutaneous Myocardial Revascularization Devices 
  Ultrasonic Angioplasty Catheters 
  Vascular and Arterial Graft Prostheses 
  Vascular Hemostasis Devices  
 
4. Dental   
  Absorbable Materials to aid in the healing of periodontal defects and other maxillofacial 
applications 
  Bone Morphogenic Proteins with and without bone, e.g., Hydroxyapatite (HA) 
  Dental Lasers for hard tissue applications 
  Endosseous Implants and associated bone filling and augmentation materials used in 
conjunction with the implants 
  Subperiosteal Implants 
  Temporomandibular Joint (TMJ) Prostheses  
 
5.  Ear, Nose And Throat  
  Absorbable Gelatin Sponge 
  Auditory Brainstem Implants 
  Cochlear Implants 
  Endolymphatic Shunt Tubes with or without valve 
  ENT Cements/Adhesives 
  Implantable Bone Conduction Hearing Aids 
  Implantable Middle Ear Hearing Device 
  Injectable Teflon Paste 
  Laryngeal Implants 
  Synthetic Polymer Materials 
  Tissue Autofluorescent Devices 
  Vocal Cord Medialization (Augmentation) Devices 
 
6.  Gastroenterology And Urology  
  Anastomosis Devices 
  Balloon Dilation Catheters for benign prostatic hyperplasia (BPH) 
  Biliary Stents 
  Components of Water Treatment Systems for Hemodialysis 
  Dialysis Delivery Systems 
  Electrical Stimulation Devices for sperm collection 
  Embolization Devices for general urological use 
  Extracorporeal Circulation Systems 
  Extracorporeal Hyperthermia Systems 
  Extracorporeal Photopheresis Systems 
1 1 Contains Nonbinding Recommendations 
 
 
 
  Femoral, Jugular and Subclavian Catheters 
  Hemodialyzers 
  Hemofilters 
  Implantable Electrical Urinary Incontinence Systems 
  Implantable Penile Prostheses 
  Injectable Bulking Agents for incontinence 
  Lithotripters (e.g., electrohydraulic extracorporeal shock-wave, laser, powered mechanical, 
ultrasonic)  
  Mechanical/Hydraulic Urinary Incontinence Devices  
  Penetrating External Penile Rigidity Devices with components that enter the vagina  
  Peritoneal Dialysis Devices  
  Peritoneal Shunt  
  Plasmapheresis Systems  
  Prostatic Hyperthermia or Thermal Ablation Devices 
  Retention Type (Foley) Balloon Catheters for long term use (> 28 days) 
  Suprapubic Urological Catheters and accessories 
  Urethral Occlusion Devices for greater than 14 days use 
  Urethral Sphincter Prostheses  
  Urological Catheters with anti-microbial coatings  
  Urological Stents (e.g., urethral, prostate, etc.)  
 
7.  General And Plastic Surgery  
  Absorbable Adhesion Barrier Devices  
  Absorbable Hemostatic Agents  
  Artificial Skin and Interactive Wound and Burn Dressings  
  Breast Implants 
  Injectable Collagen  
  Implantable Craniofacial Prostheses  
  Repeat Access Devices for surgical procedures  
  Sutures  
 
8.  General Hospital  
  Implantable Vascular Access Devices (Ports) - if new routes of administration or new design 
  Infusion Pumps (implantable and closed-loop - depending on the infused drug)  
 
9. Neurological   
  Electroconvulsive Therapy (ECT) Devices  
  Hydrocephalus Shunts  
  Implanted Intracerebral/Subcortical Stimulators  
  Implanted Intracranial Pressure Monitors  
1 2 Contains Nonbinding Recommendations 
 
 
 
  Implanted Spinal Cord and Nerve Stimulators and Electrodes  
  Neurological Catheters (e.g., cerebrovascular, occlusion balloon, etc.) 
  Transcutaneous Electric Nerve Stimulation (TENS) Devices for treatment of chest 
pain/angina 
 
10.  Obstetrics And Gynecology  
  Abdominal Decompression Chamber 
  Antepartum Home Monitors for Non-Stress Tests  
  Antepartum Home Uterine Activity Monitors  
  Catheters for Chorionic Villus Sampling (CVS)  
  Catheters Introduced into the Fallopian Tubes  
  Cervical Dilation Devices  
  Contraceptive Devices: 
o  Cervical Caps  
o  Condoms (for men) made from new materials (e.g., polyurethane)  
o  Contraceptive In Vitro Diagnostics (IVDs)  
o  Diaphragms  
o  Female Condoms  
o  Intrauterine Devices (IUDs)  
o  New Electrosurgical Instruments for Tubal Coagulation  
o  New Devices for Occlusion of the Vas Deferens  
o  Sponges  
o  Tubal Occlusion Devices (Bands or Clips)  
  Cryomyolysis 
  Devices to Prevent Post-op Pelvic Adhesions  
  Embryoscopes and Devices intended for fetal surgery 
  Endometrial Ablation Systems  
  Falloposcopes and Falloposcopic Delivery Systems  
  Fundal Pressure Belt (for vaginal assisted delivery) 
  Gamete and Embryo Surgical Systems 
  Intrapartum Fetal Monitors using new physiological markers  
  New Devices to Facilitate Assisted Vaginal Delivery  
  Operative Hysteroscopy and Laparoscopy  
  Uterine Artery Embolization  
 
11. Ophthalmics 
  Aniridia Intraocular Lenses (IOLs) or Rings (for iris reconstruction) 
  Capsular Tension Rings 
  Class III Ophthalmic Lasers  
1 3 Contains Nonbinding Recommendations 
 
 
 
  Contact Lens Solutions intended for direct instillation (e.g., lubrication/rewetting solutions) 
in the eye using new active agents or preservatives with no history of prior 
ophthalmic/contact lens use or not generally recognized as safe for ophthalmic use  
  Corneal Storage Media 
  Extended Wear Contact Lens (i.e., including a single overnight use) 
  Glaucoma Treatment Devices (e.g., trabeculoplasty devices, devices that treat ciliary bodies, 
devices that raise or lower intraocular pressure, aqueous shunt/drainage devices, etc.) 
  Implants for Refractive Purposes (e.g., intraocular lenses, corneal implants, scleral expansion 
bands, etc.) 
  Intraocular Lenses (IOLs)  
  Keratoprostheses  
  Refractive Surgical Devices (e.g., lasers, electrical current devices, thermal and non-thermal 
keratoplasty devices, ablation devices, expansion rings, treatment of ciliary bodies, etc.) 
  Retinal Disease Treatment Devices (e.g., electrical stimulation devices to treat macular 
degeneration, lasers to ablate epiretinal membranes and vitreous strands, etc.) 
  Retinal Prosthesis (implant) 
  Retinal Reattachment Devices (e.g., fluids, gases, perfluorocarbons, perfluorpropane, silicone   
oil, sulfur hexafluoride, balloon catheter for retinal reattachment) 
  Viscosurgical Fluids (viscoelastics) 
 
12.  Orthopedics And Restorative  
  Anti-Adhesion Gels 
  Bone Growth Stimulators  
  Bone Morphogenetic Proteins/Biodegradable Scaffolds combination products, with or 
without allograft/autograft combinations and with or without metallic implant 
  Bone Void Fillers (hydroxyapatite and other materials) 
  Bovine Collagen Meniscus Implants 
  Computer Guided Robotic Surgery  
  Implantable Peripheral Neuromuscular Stimulators 
  Implantable Prostheses (ligament, tendon, hip, knee, finger)  
  Implantable Spinal Devices 
  Injectable Sodium Hyaluronate 
 
13. Radiology   
  Boron Neutron Capture Therapy  
  Hyperthermia Systems and Applicators  
 
Also see the FDA Information Sheet Guidance on Frequently Asked Questions about Medical 
Devices. 
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