FDA

CVM CFSAN CDRH CBER CDER

ODE OSM OSB* OSEL OCER OC OIVD

DB

DP

DIAM

DCMS

Electromag EPES

Opt Ther Opt Diag

DAGID

DCD*

DGRND*

DOED*

DRARD*

DESE

DSFM

Who We Are

Device Classification

• Classification determines extent of regulatory control

– Class I – general controls, GMP and labeling – Class II – special controls, to assure safety

and effectiveness, e.g., X-ray machine – Class III - premarket approval needed with

clinical data

Regulatory Review: Main Pathways to Market

• Premarket Approval (PMA) (Class III)

• Premarket Notification 510(k)(Class II)

• Company (not product) Registration (Class I)

CDRH’s Office of Science & Engineering Laboratories

• Applied Mathematics & Medical Imaging • Biology • Chemistry and Material Science• Electrical & Software Engineering• Fluid and Solid Mechanics• Physics

Approximately 200 laboratory scientists working in

Some Potential Collaborations

• Wireless technologies

• Optics• Neurophysiology• Fluid mechanics• Mechanical

engineering• Robotics• Software reliability

Materials Tissue engineering Nanotechnology Toxicology/biocompatibility Medical imaging Computational modeling Epidemiology/statistics Acoustics/ultrasound

Microvacuoles in

Foldable Intraocular Lenses

Electrophysiological model of the human torso

• Unique Model– Ability to simulate

non-linear dynamics & electrophysiology as well as application of strong shocks

• Initial validation of simulation using data from rabbit heart.

EXAMPLE: Neural stimulation technologies

• Cochlear implants• Prosthetic retinas• Spinal cord stimulators• Deep brain stimulators• Functional electrical stimulation • Vagus nerve stimulators• Magnetic stimulation• Stimulators for evacuation/incontinence

Stimulation Issues • Heating

(energy)• Dielectric breakdown

(E-field strength)• Electrochemical toxicity

(charge density)• Excitoxicity

(pulse rep rate, E-field)• Physiologic interference

(rep rate, E-field)• Electromagnetic Interference

RFID Testing

71%

29%

11%

89%

0%

100%

0%10%20%30%40%50%60%70%80%90%

100%

125-135 kHz 13.56 MHz 915 MHz

RFID Frequency Band

Percentage of ICD Tests with Reaction(s)

Reaction No Reaction

Computational Modeling

• 8000 Processors• 8 Terra Flops• 3 FTE support

ASK CHILDREN Study

Anticipate Specific Kinds of CHILDREN Challenges for Neurologic Devices STUDY

Kristen Bowsher, PhD, Co-Investigator

Victor Krauthamer, PhD, Co-Investigator

Carlos Peña, PhD, Primary Investigator

Joy Samuels-Reid, MD, Co-Investigator

Objectives• Collect clinical data related to neurologic device prostheses

(prosthetics) for children to help identify human factors, safety, usability, and adverse events associated with prosthetic devices;

• Collate and analyze clinical data associated with prosthetics for pediatric use that are important to bringing devices expeditiously to market, organized by multiple headers including (but not limited to) device type, pediatric subpopulations, disorder, condition, and intended use;

• Plan, organize, and execute a meeting of subject matter experts (consultants) in the field to further evaluate data and propose recommendations concerning overcoming regulatory challenges associated with bringing pediatric prosthetics to market; and

• Establish a framework of science based recommendations important towards helping expedite pediatric prostheses to market.

Eliminate disparities between people with disabilities and the general population in:

employment,participation &

community livingandhealth and

function.

Policy

Practice

Behavior

System Capacity

NIDRR Logic Model: Planning for Research OutcomesSituation: Significant gaps exist in knowledge, skills, policy, and practice and system capacity that prevent people with disabilities from

having equal access to opportunities for employment, health and function, and participation.

Long-term Outcome Arenas

– Changes in Overall

Conditions

Short Term Outcome Arenas – Advances in Understanding,

Knowledge, Skills, and Learning Systems via:

Intermediate Outcome Arenas –

Adoption and Use of New Knowledge Leading to

Changes/ improvements in:

Major Domains of NIDRRResearch

Contextual Factors: Variable funding; scientific and technological advancements; societal attitudes; economic conditions; changing public policies; coordination and cooperation with other government entities.

Performance Assessment & Outcomes Evaluation

Intended Beneficiaries

Intermediate Beneficiaries

R&DC-B KT

People with

disabilities& family

members

• Researchers• Clinicians• Service providers• Educators• Policy experts• Federal & non-federal

partners• Industry reps &

product developers• Employers• Media• Consumer advocates• People with

disabilities & family members

Discoveries

Interventions, Products, Devices, & Environmental

Adaptations

Theories, Measures, & Methods

05/05/05

St. Croix Med-El

Soundtec

Otologics

Implex

IMEHD

Technologies

Inside the High Bay

Evaluation of Applied Forces and EMG of the Young, Aged & Stroke Population in a 3D Arm Workspace

EMC of Powered wheelchairs

• Many models experienced sudden unintended motion when exposed to RF fields of a few volts/meter.

• This could cause persons to be thrown from their wheelchairs, or to be thrust into traffic in a busy street.

• FDA lab and outdoor tests demonstrated that RFI from nearby high-power police-car transmitters could induce unintended motion in several models of powered wheelchairs.

• Witters, D.M.; Ruggera, P.S., "Electromagnetic compatibility (EMC) of powered wheelchairs and scooters," Engineering in Medicine and Biology Society, 1994. Engineering Advances: New Opportunities for Biomedical Engineers. Proceedings of the 16th Annual International Conference of the IEEE EMBS, vol.2, pp.894-895, 1994.

• ANSI/RESNA WC Vol. 2-1998 and ISO 7176-21

RESEARCH OPPORTUNITIES

• Faculty members

• NIDRR grantees

• Graduate students, post-docs

• Senior OSEL research collaborators

• Unique medical device lab facilities

• Synergistic research