1 

Welcome to today’s 

FDA/CDRH Webinar

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participants.

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Conference Number: PWXW4445343 
REGULATORY OVERVIEW FOR 

DEVELOPERS AND SPONSORS OF 

NEUROLOGICAL DEVICES:

An Introduction to

Premarket Approvals (PMA)

Wednesday, July 26, 2017

1:00PM-2:30PM
3 

Agenda

• Introduction to the Premarket Approvals Process 

• How Sponsors and Principle Investigators Move Their 

Product to Market 

• Clinical Testing

• Non-Clinical Testing Overview 

• Post-Approval Studies

• Bioresearch Monitoring

• Question & Answer Session
4 

Introduction 

 Michael Hoffman

 Deputy Director 

Division of Neurological and Physical Medicine Devices

Office of Device Evaluation

Center for Devices and Radiological Health
5 

CDRH

Vision

• Patients in the U.S. have access to 

high-quality, safe, and effective 

medical devices of public health 

importance first in the world. 

• The U.S. is the world’s leader in regulatory science, 

medical device innovation and manufacturing, and 

radiation-emitting product safety. 

• U.S. post-market surveillance quickly identifies 

poorly performing devices, accurately characterizes 

real-world performance, and facilitates device 

approval or clearance. 

• Devices are legally marketed in the U.S. and remain 

safe, effective, and of high-quality. 

• Consumers, patients, their caregivers, and providers 

have access to understandable science-based 

information about medical devices and use this 

information to make health care decisions. 
6 

Medical Device Definition

Section 201(h) of the Federal Food, Drug and Cosmetic Act 

(21 U.S.C. 321) states, in part: 

• “Device... means an instrument, apparatus, implement, 

machine, contrivance, implant, in vitro reagent, or other similar 

or related article, including any component, part, or accessory, 

which is...”

• “...intended for use in the diagnosis of disease or other 

conditions, or in the cure, mitigation, treatment, or 

prevention of disease, in man...” or

• “...intended to affect the structure or any function of the body of 

man and which does not achieve any of its primary intended 

purposes through chemical action....”
7 

Regulatory Pathways for Medical 

Devices

Can Be 

Legally 

Marketed 

in the 

United 

States

PreMarket Approval (PMA) Submission

De Novo Submission

Premarket Notification 510(k)

NonClinical & Clinical Study Phase

May occur over multiple years of development

FDA Decision Points

Sponsors submit a presubmission to the FDA 

to start early 

regulatory discussions

and develop a path forward

Sponsors Apply to FDA to Market Device

Humanitarian Device

Exemption 

180* Days

120* Days

90* Days

75* Days

*Number of days noted is days the submission is under review by the FDA, not the total time that it may take to get the device technology to 

market or through the review process. In some cases, the review process may take longer depending upon the particular device, technology, 

indication for use, user, and risk of the device.

Anderson, Leigh et al. FDA Regulation of Neurological and Physical Medicine Devices: Access to

Safe and Effective Neurotechnologies for All Americans. Neuron , Volume 92 , Issue 5 , 943 - 948 
8 

Examples of Neurological Products Reviewed in 

the FDA’s Center for Devices and Radiological 

Health (CDRH)

Neurodiagnostic and 

Neurosurgical Devices

•Cranial Materials & 

Other Sealants

•EEG & Non-EEG 

Diagnostic Devices

•Neurocognitive 

Diagnostic Devices

•Surgical Instruments & 

Tools for the 

Neurovasculature

•Stereotactic Systems 

for the 

Neurovasculature

Neurointerventional 

Devices

•Embolization Coils

•Flow Diverters

•Guidewires & 

Catheters for the 

Neurovasculature

•Neurothrombectomy 

Devices

•Neurovascular & 

Cerebral Interventional 

Devices

•Cerebrospinal Fluid 

Shunts

Neurostimulation 

Devices Neurology

•Stimulation Devices for 

Movement Disorders, 

Epilepsy, Alzheimer’s 

Disease, Headache, and 

Traumatic Brain Injury

•Devices may include 

cortical stimulation 

devices and deep brain 

stimulation devices

Neurostimulation 

Devices Psychiatry

•Stimulation Devices 

for Major Depression, 

Obsessive Compulsive 

Disorder, and Post 

Traumatic Stress 

Disorder

•Devices may include 

cranial electrical 

stimulation devices, 

electroconvulsive 

therapy, and 

transcranial magnetic 

stimulation devices

Physical Medicine & 

Rehabilitation Devices

•Brain Computer 

Interfaces

•Diathermy

•Functional Electrical 

Stimulators

•Iontophoresis Devices

•Massagers/Vibrators

•Orthoses, Exoskeletons

•Powered Muscle 

Stimulators

•Rehabilitation 

Equipment

•Wheelchairs, Walkers
9 

Experience in Moving 

Neurological Medical Devices 

From Bench to Market

Clot Retriever for

Ischemic Stroke

Neurostimulation Device

Prosthetic Arm For Migraine

Microcatheters for the 

Ablation Therapy neurovasculature Cognitive Function

following concussion
10

More information is available in the Center for 

Devices and Radiological Health (CDRH)’s industry 

education page, CDRHLearn. 

https://www.fda.gov/downloads/Training/CDRHLearn/

UCM400786.pdf 

Background on Regulatory 

Requirements 
11

Premarket Approval Statute and 

Regulations

• Statute: Section 515 of the Food, Drug, and Cosmetic 

Act (FD&C Act) [21 USC 360e]

– Establishes the general requirement for PMAs

– https://www.gpo.gov/fdsys/pkg/USCODE-2010-

title21/html/USCODE-2010-title21-chap9-subchapV-partAsec360e.htm 

• Regulations: 21 CFR 814

– https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFR

Search.cfm?CFRPart=814&showFR=1 

– Includes the regulations for Humanitarian Device Exemption 

(HDE, not covered as part of this webinar)
12

How are Premarket Approvals 

Different?

• Safety and effectiveness standard

– Not “substantial equivalence”

• Post-market requirements

– Annual reporting

– Manufacturing changes

• Review process

– Filing review

– Manufacturing review
13

Premarket Approvals: Modular vs. 

Traditional

• Traditional: Complete PMA application is submitted 

to the FDA at once

• Modular: Contents of a PMA application are broken 

down into components and submitted over time

• Modular review may or may not suit your needs well; 

make sure you understand the implications and 

timelines, and ask questions

Guidance – “Premarket Approval Application Modular Review”: 

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocume

nts/ucm089767.pdf 
14

Premarket Approval Review 

Process

Important timeframes:

• Refuse to Accept (RTA) review (within 15 days of 

receipt)

• Filing review (within 30 days of receipt)

• Substantive review (first 90 days after receipt)

In depth overview of the PMA Review Process is available in 

CDRH’s Device Advice section at: 

https://www.fda.gov/medicaldevices/

deviceregulationandguidance/howtomarketyourdevice/ 

premarketsubmissions/premarketapprovalpma/ucm047991.htm 
15

Premarket Approval Review Process 

(Post-Substantive Interaction)

Substantive review ends with “substantive interaction” 

decision point (SI). By day 90, the FDA will: 

• Request additional information (by letter) if needed to help 

determine the reasonable assurance of safety and 

effectiveness of the device. When this is done, review clock 

stops. 

OR

• Determine there are minor questions that can be addressed 

interactively. When this is done, review clock does not stop. 
16

Premarket Approval Review Process 

(Post-Substantive Interaction)

After substantive interaction: 

• All remaining questions will be resolved 

interactively

• Be prepared for multiple interactions about 

labeling

• If a panel meeting is scheduled, it will likely occur 

after the substantive interaction decision point
17

Advisory Committee Input 

• 21 CFR 814.44(a) - “FDA will begin substantive review of a 

PMA after the PMA is accepted for filing under 814.42. 

FDA may refer the PMA to a panel on its own initiative, and 

will do so upon request of an applicant, unless FDA 

determines that the application substantially duplicates 

information previously reviewed by a panel.”

• Applicants may request that the FDA refer their PMA to an 

appropriate panel for a formal review and recommendation if 

a major deficiency letter is received. 

• The panel’s input is a recommendation; the FDA makes the 

final decision on the PMA. 
18

Premarket Approval Supplements

• Several types:

– “Panel-track Supplement”

– “180-Day”

– “Real-time Review” (has its own guidance document)

– “30-Day Notice” (has its own guidance document)

– “Special Supplement: Changes Being Effected”

Guidance – “Modifications to Devices Subject to Premarket Approval (PMA) - 

The PMA Supplement Decision-Making Process”: 

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidan

ce/GuidanceDocuments/UCM089360.pdf
19

How Sponsors and Principle 

Investigators Move Their 

Product to Market 
20

Safety

Reasonable assurance that a device is 

safe: Based on valid scientific evidence, the 

probable benefits of the device for its intended 

uses and conditions of use, when 

accompanied by adequate directions and 

warnings against unsafe use, outweigh any 

probable risks. 
21

Effectiveness 

Reasonable assurance that a device is 

effective: Based on valid scientific evidence, 

in a significant portion of the target population, 

the use of the device for its intended uses and 

conditions of use, when accompanied by 

adequate directions for use and warnings 

against unsafe use, will provide clinically 

significant results. 
22

Reasonable Assurance 

and 

Valid Scientific Evidence

• The FDA relies on valid scientific evidence to 

determine whether there is reasonable assurance 

that the device is safe and effective.

• Valid scientific evidence can come from:

• well-controlled investigations, 

• studies and objective trials without matched controls, 

• well-documented case histories conducted by qualified 

experts, and 

• reports of significant human experience with a marketed 

device. 
23

Well-Controlled Clinical 

Investigation

The plan or protocol for the study, and the report of 

the results should include the following:

• A clear statement of the objectives of the study

• A method of selection of the subjects that includes 

the following: 

– Adequate assurance that subjects are suitable for the 

study

– Minimization of any possible bias

– Comparability between test groups and any control 

groups
24

Well-Controlled Clinical Investigation, 

cont. 

Should also include: 

• Explanation of the methods of observation and 

recording of results utilized

• Comparison of results of treatment or diagnosis 

with a control to permit quantitative evaluation

• Summary of the methods of analysis and an 

evaluation of the data derived from the study, 

including any appropriate statistical methods 

utilized
25

Pre-Submission Guidance

“Requests for Feedback on Medical Device 

Submissions: The Pre-Submission Program and 

Meetings with Food and Drug Administration 

Staff”: 

http://www.fda.gov/downloads/medicaldevices/d

eviceregulationandguidance/guidancedocuments/

ucm311176.pdf 
26

NON-CLINICAL TESTING 

OVERVIEW 

Stacie Gutowski, PhD

Biomedical Engineer

Division of Neurological and Physical Medicine Devices

Office of Device Evaluation

Center for Devices and Radiological Health
27

Non-Clinical Testing

• Also known as “pre-clinical testing”

• Encompasses all testing conducted outside 

of a human subject

– Performance/bench testing

• Includes standards testing

– Animal testing
28

Common Non-Clinical Tests

• Testing conducted among many device types

– Electrical safety 

– Battery reliability (if applicable)

– Electromagnetic compatibility (including MR compatibility)

– Biocompatibility

– Sterility and shelf life

– Software

– Engineering

– GLP-compliant animal studies 

• FDA Guidance Documents 

(https://www.fda.gov/Regulatoryinformation/Guidances/) 

• FDA Recognized Consensus Standards Database 

(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/

search.cfm) 
29

Other Performance Testing 

• Device specific tests

– May or may not have specific guidance documents 

and/or standards

– Always check the databases at fda.gov

• General examples

– Functional testing (demonstrate the device will 

function as intended)

– Mechanical testing 

– Fatigue testing

– Coating integrity, if applicable

– Others as needed
30

Considerations for 

Non-Clinical Testing

• Test devices should be identical to final, 

finished device intended for human use

– Same manufacturing processes (materials, 

equipment, environment, etc.) 

– Post-sterilization processing

• To demonstrate that sterilization does not alter 

performance

• If the test device is not identical, justifications 

for not testing should be provided
31

Considerations for 

Non-Clinical Testing, cont.

• Full test reports should be included 

(may not apply when testing is completed in accordance with 

standards)

– Summary reports do not always provide sufficient 

detail

• Testing in compliance with FDA-recognized 

consensus standards should be listed on 

Form FDA 3514 

• Testing to alternate standard is not advised if 

there is a corresponding FDA-recognized 

standard 
Post-Approval Studies (PAS)

Samuel Raben, PhD

Mechanical Engineer

Division of Neurological and Physical Medicine Devices

Office of Device Evaluation

Center for Devices and Radiological Health
33

Post Approval Studies

• May be required as condition of approval of premarket application 

under 21 CFR 814.82(a)(2) to assure continued safety and 

effectiveness of an approved device.

– May be clinical or pre-clinical studies

– May be result of long-term safety and effectiveness of device that 

cannot be addressed by premarket data

• Post approval study protocols may be developed and agreed upon by 

FDA and applicant during premarket approval review or after 

premarket approval to be reviewed under a premarket approval 

supplement.

• The decision of whether a post approval study is needed and the 

general framework of the study will always be concurred during the 

premarket approval review process and/or communicated in the 

approval decision.
34

Post Approval Study Protocol

• Background (e.g., regulatory history, device description, 

indications for use)

• Purpose of study

• Study objectives and hypotheses

• Study design

• Study population (inclusion/exclusion criteria, definition 

and source of comparator group)

• Sample size calculation (statistically justified and based on 

study hypothesis)

• Primary and secondary endpoints

• Length of follow-up, follow-up schedule, baseline and 

follow-up assessments
35

Post Approval Study Protocol 

Cont.

• Description of data collection procedures

• Statistical analysis

• Data collection forms, informed consent forms, 

IRB approval forms

• Reporting requirements for interim and final 

reports

• Study milestones/timelines
36

Interim & Final Reports 

• Interim report: Submitted every 6 months for the first 

2 years of the post approval study and annually 

thereafter, from the date of the premarket approval 

letter.

– Should be an update of the study progress with respect 

to the study design elements described in the protocol 

and summary of safety and/or effectiveness data and 

an interpretation of study results to date.

• Final report: Submitted no later than 3 months after 

study completion (i.e., all subjects have completed 

follow-up).
37

Failure to Complete 

Post Approval Study 

• May result in withdrawal of approved PMA

• If study cannot be completed, please 

communicate with the FDA as soon as 

possible in interim reports or through a 

PMA supplement.
38

Guidances for Post Approval 

Studies

• Guidance for Industry and FDA Staff “Procedures for Handling 

Post-Approval Studies Imposed by PMA Order”

– Issued on August 1, 2007

– https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationa

ndGuidance/GuidanceDocuments/ucm071013.pdf

• Post-Approval Studies Public Database

– https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_p

as.cfm

– General status information on each PAS ordered since January 1, 

2005

• FDA Post-Approval Studies Website

– https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidan

ce/PostmarketRequirements/PostApprovaStudies/default.htm
39

Bioresearch Monitoring 

CDR Isatu Bah, MS, BSN, RN

Division of Bioresearch Monitoring

Office of Compliance

Center for Devices and Radiological Health 
40

Bioresearch Monitoring Program 

Description

• A comprehensive, 

FDA-wide program

• On-site inspections 

and data audits

• Designed to monitor 

all aspects of the 

conduct and reporting 

of FDA-regulated 

research
41

Bioresearch Monitoring 

Program Objectives

• To protect the rights, safety, and welfare of human 

research subjects

• To determine the accuracy, reliability, and integrity of 

clinical trials data submitted to the FDA

• To assess compliance with the FDA’s regulations 

governing the conduct of clinical trials including those 

for informed consent and ethical review
42

Bioresearch Monitoring 

Regulations: FDA-Wide

• 21 CFR Part 50: Protection of Human Subjects

• 21 CFR Part 54: Financial Disclosure

• 21 CFR Part 56: Institutional Review Boards

• 21 CFR Part 58: Good Laboratory Practice for 

Non-Clinical Laboratory Studies

• 21 CFR Part 11: Electronic Records/Signatures
43

Medical Device Regulations 

• 21 CFR 807: Registration/Listing

• 21 CFR 807 Subpart E - Premarket Notification 

(510k)

• 21 CFR 809: In Vitro Diagnostic Products (IVD)

• 21 CFR 812: Investigational Device Exemptions 

(IDE)

• 21 CFR 814: Premarket Approval (PMA) and 

Humanitarian Device Exemption (HDE)
44

Pre-Inspection

• Select sites

– Consider number of subjects, protocol 

deviations, adverse events, inspection

history, etc. 

• Issue assignments

• Pre-announce* – usually three to five days in advance 

– allows the study site to ensure that the 

site staff and all required records are available

* unless “For Cause”

• Memo

• Date:

• To: District Office 

• From: BIMO

• Subject: PMA #

• ......................

......................

......................

......................

........................ 
45

Inspection Conduct

• Issue “Notice of Inspection”

• Interview site personnel

• Review records

• Audit data 

• Issue 483, if deviations from the regulations 

• Discuss verbal observations, if any
46

Documents Reviewed During PMA 

Inspections 

• Standard operating procedures 

(monitoring logs, investigator 

agreement, clinical site procedures, 

and correspondence between the 

Sponsor, IRB, CIs, FDA, etc.)

• Progress Reports (adverse events, 

protocol deviations...)

• Subject Records (medical record, 

Case Report Forms,...)

• Data Line Listings (Stratified by site 

then site)

• Study Protocols & Revisions

• Informed Consent Versions

• Hospital and laboratory records

• Radiological files

• Device accountability records, device 

Use, disposition, and shipping/return 

records

• Financial Disclosure Form - Form FDA 

3454

http://www.fda.gov/ICECI/ComplianceManuals/ComplianceProgramManual/ucm255614.htm
47

If FDA-483 Issues...

• Be responsive

• Present any corrective actions taken to the FDA 

investigator

• Respond in writing

– Assess root cause and extent of the problem

– Include corrective and preventive actions 

– Include projected timelines for implementation

– Include supporting documentation

Consider re-evaluating corrective/preventive actions in 6 months
48

Post-Inspection

• Review Establishment Inspection Report (EIR)

• Review any 483 response(s)

• Classify inspection

• Issue correspondence and review memos

 Considerations:

– Impact on human subject protection

– Impact on data integrity

– Adequacy of response

– Inspectional history
49

Compliance Classifications

• No Action Indicated (NAI)

– No or minor objectionable conditions or practices

• Voluntary Action Indicated (VAI)

– Objectionable conditions/practices

– Isolated, low-risk, can be corrected easily

• Official Action Indicated (OAI)

– Significant or egregious violations of regulations

– Sanctions recommended
50

Opportunities for Collaboration

• Pre-submissions meetings (Q-sub)** 

• Modular PMAs

• 510(k)/De Novo meetings

• IDE meetings

• Pre-PMA meetings** 
51

Contact Information 

Phone: (301) 796-5490

E-mail:BIMO-CDRH@fda.hhs.gov
PMA Manufacturing 

Information 

Vesa Vuniqui

Consumer Safety Officer 

Division of Manufacturing and Quality

Office of Compliance

Center for Devices and Radiological Health
53

Manufacturing Related 

Submissions 

• Original/modular PMAs

• Pre-approval inspections

• Site change supplements

• 30-day notices
54

ORIGINAL/MODULAR PMA
55

Major Steps for PMA

• Review of manufacturing 

information

• Inspection requests generated 

and sent to Office of Regulatory 

Affairs

• Inspections scheduled and 

completed through Office of 

Regulatory Affairs

• Establishment Inspection 

Report written

• Establishment Inspection 

reviewed in CDRH

Office of Compliance

District Offices

Office of Compliance
56

Original PMAs

• Manufacturing information reviewed by CDRH Office of 

Compliance

• Should include information outlined in the guidance, 

“Quality System Information for Certain Premarket 

Application Reviews; Guidance for Industry and FDA 

Staff” dated February 3, 2003

– https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuid

ance/GuidanceDocuments/ucm070899.pdf

• Consistent with quality system regulation requirements (21 

CFR 820) and is divided into sections:

– Design Controls 

– Manufacturing Controls

• Ensures that the premarket submissions comply with the 

content requirements (21 CFR 814.20(b)(4))
57

Manufacturing Section Information

Please be sure to include:

• Cover letter

• Overview of what the manufacturing section 

contains and how it is organized

• Device description

• Overview of the manufacturing facility(ies) 

• Copy of your quality manual

• List of standards used in the manufacturing 

process
58

Manufacturing Section Information, 

cont.

• Two principle component sections

– Design control information

– Information on other key procedures 

• Mostly manufacturing but also includes procedures such as 

complaint handling, corrective and preventive action

• FDA guidance asks mostly for procedures

• In addition to procedures, you can submit a 

narrative summary of the procedures

• Identify location of attached procedures

• Submit separate volumes for different manufacturing 

sites or vendors
59

Office of Compliance Review Process

• Office of Compliance will review the manufacturing 

section of the submission according to the 

guidance document. 

• Office of Compliance will communicate their 

assessment to the applicant if there are 

deficiencies identified in the Quality System 

information included in the submission.

– Deficiencies may be communicated in a formal deficiency letter or 

via e-mail through an interactive review process.
60

PMA Pre-Approval Inspections

• Conducted at sites manufacturing finished 

devices, critical components, or performing 

sterilization 

• Will be scheduled on or after the date you 

indicate that the site will be ready for inspection

– Sites that are not ready for inspection may result in 

delayed approval of the PMA (approvable pending 

good manufacturing practices)

• Based on any past inspection history

• Domestic or foreign as appropriate
61

SITE CHANGE SUPPLEMENTS
62

When to Submit a Site Change 

Supplement

• Site was not approved as part of the original 

PMA or a PMA supplement

• Site(s) was (were) approved as part of the 

original PMA or a PMA supplement, but for 

the performance of different manufacturing 

activities

• Note: Draft guidance previously issued for 

comment on October 21, 2015
63

Site Change Supplement Content

• Similar to Original PMA manufacturing 

information

• Does not require Design Control information 

(820.30) since the design would not change

• Should clearly indicate when validations will 

be complete and facility ready for inspection
64

Pre-approval Inspections 

• Subject to pre-approval inspection

• Follows the same time goals as in an original PMA

• CDRH Office of Compliance will communicate 

their assessment to the applicant if there are 

deficiencies identified in the Quality System 

information included in the submission
65

30-DAY NOTICE
66

What Changes Qualify 

for a 30-Day Notice 

• Manufacturing process change that could 

affect the safety or effectiveness of the device

– Changes to the manufacturing procedure

– Changes to the method of manufacture

• Guidance document:

https://www.fda.gov/downloads/MedicalDevices/Devic

eRegulationandGuidance/GuidanceDocuments/UCM

080194.pdf
67

Changes Typically Appropriate

for 30-Day Notice

• Manual process to an automated process

• Changes to a cleaning process which is 

performed in manufacturing device

• Change in machining lubricants

• Sterilization cycle or sterility dose auditing

• Addition of manufacturing space to current 

facility or the addition of manufacturing line 

at same facility
68

Changes Not Appropriate 

for 30-Day Notice

• New manufacturing site

• Changes to device design

– Device specifications

– Device material changes

• Minor changes that are “annual reportable” 

because they do not affect safety or 

effectiveness
69

30-Day Notice Review Clock 

• Acceptance of 30-day notice

• Conversion to 135-day supplement

– May be converted with or without deficiencies

– Common for deficiencies to be conveyed

• Approval of 135-day supplement

• Not approvable 135-day supplement
70

30-Day Notice Information 

• Description of change

• Summary of the data or information supporting 

the change

• Statement that the change was made under 

requirements of §520(f) of FDCA and 21 CFR 

Part 820

• Reason for change, including description of 

any adverse event or field failures being 

addressed 
71

Closing Remarks 
72

Pre-Submissions

WHAT: an opportunity to obtain FDA feedback prior to 

IDE or marketing submission

Guidance Document

“Requests for Feedback on Medical Device 

Submissions: The Pre-Submission Program and 

Meetings with Food and Drug Administration Staff” 

(Issued February 18, 2014 ) 
73

NeuroView

FDA Regulation of 

Neurological and Physical 

Medicine Devices: Access 

to Safe and Effective 

Neurotechnologies for All 

Americans

Neuron. 2016 Dec 7;92(5):943-

948. doi: 

10.1016/j.neuron.2016.10.036. 

NEW FDA website for 

Neurological Devices:

http://www.fda.gov/MedicalDevic

es/ProductsandMedicalProcedur

es/ 

NeurologicalDevices/default.htm
74

It’s About the Patients
75

Questions?

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

Please complete a short survey about your FDA CDRH webinar 

experience. The survey can be found at www.fda.gov/CDRHWebinar

 immediately following the conclusion of the live webinar.