Presentation

Critical Issues in Telemedicine Technology I

FDA Regulations

Medical Device Manufacturing

UL/CE/IEC Standards

Case studies for telehealth products.

HIPAA

A. Stewart Ferguson, PhDDirector of Telehealth / AFHCAN

Alaska Native Tribal Health Consortium

Anchorage, AK

Joe D'IorioTelehealth Manager

TANDBERG

Reston, VA

Douglas J. McClureCorporate Manager

Partners Telemedicine

Boston, MA

When does a Popsicle Stick become a Medical Device ?

TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H - MEDICAL DEVICES PART 880 -- GENERAL HOSPITAL AND PERSONAL USE DEVICES

Subpart G -- General Hospital and Personal Use Miscellaneous Devices Sec. 880.6230 Tongue depressor.

(a) Identification. A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

[45 FR 69682-69737, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001]

FDA: Medical Device

Food Drug and Cosmetic Act (1938) section 201(h):

– The term “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

A. recognized in the national Formulary, or the US Pharmacopoeia, or any supplement to them,

B. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

C. intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals …

Topics for Presentation

• The FDA role in regulating Medical Devices

• The “types” of Medical Devices

• Quality System Regulations (QSR)

• The differences between FDA QSR and ISO 9000

The FDA Organization• The Food and Drug Administration (FDA) is charged with

protecting American consumers by enforcing the Food, Drug and Cosmetic Act of 1938.

• The FDA is located within DHHS:– 9,000 employees– $1 billion budget

– Costs each American $3 / year.

• Drugs, biologics and medical devices are among the $1 trillion worth of products regulated by the FDA.

• Oversight over 1 in every 4 dollars spent by American Consumers

FDA OrganizationDepartment of

Health & Human Services

Food and DrugAdministration

Office of theCommissioner

Center for Devices& Radiological Health

Center for BiologicsEvaluation & Research

Office of ComplianceOffice of Device

Evaluation

Activity of the CDRH

• In FY02:• 48 Original PMAs• 644 PMA supplements• 4,230 510(k)s• 312 Original IDEs

• More than 10,000 U.S. manufacturers are listed with CDRH

• Regulates more than 1700 general categories of medical devices grouped into 16 major medical specialties (panels).

Medical Device Classification Panels

• Anesthesiology• Cardiovascular• Clinical Chemistry

and Clinical Toxicology

• Dental• Ear, Nose, and Throat• Gastroenterology and

Plastic Surgery• General Hospital and

Personal Use

• Hematology and Pathology

• Immunology and Microbiology

• Neurology• Obstetrical and

Gynecological• Ophthalmic• Orthopedic• Physical Medicine• Radiology

The Food, Drug and Cosmetic Act of 1938

• “The Act” charges FDA to ensure that• Foods are safe to consume and are produced

under sanitary conditions• Drugs and devices are safe and effective for their

intended use• Cosmetics are safe and made from appropriate

ingredients• Labeling and packaging is truthful, informative, and

not deceptive.

Limitations to “The Act”

• A medical device could be marketed whether or not it worked, or was safe to use.

• FDA could seize products considered adulterated or including filthy, putrid, or decomposed substances, or prepared, packed, or held under unsanitary conditions.

• FDA could not require any kind of testing or approval of medical devices before they were marketed. (This changed in 1962 for drugs only).

Other Health Laws• The Medical Device Amendments, 1976

• Ensures safety and effectiveness of medical devices, including diagnostic products, and requires manufacturers to register with the FDA

• Introduced concept of premarket notifications, approvals, predicate devices, and performance standards.

• Safe Medical Devices Act (SMDA), 1990• Requires reporting of any medical device causing or contributing to

the death, serious illness, or injury of a patient• Requires manufacturers to conduct post-market surveillance of

implanted devices.

• Food and Drug Administration Modernization Act (FDAMA), 1997

• Establishes framework for efficient premarket review. Changed device tracking, reporting, PMAs, 510(k)s, required FDA to identify recognized standards, and instituted new approaches to labeling claims and intended uses.

• Medical Device Fee and Modernization Act, 2002• Allows FDA to collect fees to review medical device submissions

Medical Device Amendments (1976)

• Preamendment devices:– Required all devices to be classified into one

of three device classes – based on the extent of control necessary to provide reasonable assurances of safety and effectiveness.

• Medical Device classification is generally related to the risk posed by the device.

Food and Drug Administration Modernization Act (FDAMA), 1997

• Enhanced FDA’s ability to focus its device review resources on those medical devices that present the greatest risk to patients.

• Exempts Class I devices from premarket notification

• Expands use of “third party” experts to review Class I and low-to-intermediate-risk Class II devices.

Medical Device Classification• Class I.

– Not intended to be:• For use in supporting or sustaining life.• Of importance in preventing impairment to human life.

– And may not present a potential unreasonable risk of illness or injury.

– E.g. elastic bandages, tongue depressors, enema kits

• Class II – E.g. powered wheelchairs, infusion pumps, surgical drapes

• Class III– Usually used to support or sustain human life, or substantial

importance in preventing impairment of human health. – E.g. replacement heart valves, implanted cerebella stimulators.

Medical Device Classification• Class I – General

Controls• Most with exemptions 1

• Few without exemptions

• Class II – General Controls and Special Controls

• Few with exemptions 1

• Most without exemptions

• Class III – General Controls and Premarket Approval

0%

10%

20%

30%

40%

50%

60%

Class I Class II Class III

1 Exempt from Premarket Notification

General Controls

• Apply to all medical devices.• Considered to be the minimum requirements.

• Register each manufacturing location• List all marketed devices• Label devices in accordance with applicable regulations• Submit a premarket notification [510(k)], unless the device is

exempt from premarket notification or if it identified as being subject to other requirements.

• Manufacture devices in accordance with cGMP regulations (Current Good Manufacturing Practice)

Special Controls

• Apply to Class II devices.• Assume that General Controls not sufficient to

assure the safety and effectiveness of the device.

• Vary from product to product. May include:• Special labeling requirements• Conformance with certain FDA guidelines• Mandatory performance standards• Human clinical trials• Post market surveillance

510(k): Premarket Notification• Most Class II devices are cleared for commercial

distribution or marketing through this.

• 510(k) clearance (not “approval”) is based on the being substantially equivalent to a “predicate device”:

• Usually a device marketed before MDA of 1976 (preamendment device) or a postamendement device that was found to be substantially equivalent to a preamendment device.

• FDA must be convinced that:• Device performs the same function and falls within an established

type of predicate device• The technological characteristics of the new device are comparable

to the predicate device• Whatever differences in characteristics that do exist between the

new and predicate device will not raise any new safety and effectiveness questions.

Where does the term 510(k) come from?

• Food Drug and Cosmetic Act section 510(k):

– Each person who proposes to begin delivery for introduction into interstate commerce for commercial distribution of a device intended for human use shall, at least ninety days before making such introduction or delivery, report to the Secretary (in such form and manner as the Secretary shall by regulation prescribe) –

(1) the class in which the device is classified

(2) action taken by such person to comply with requirements applicable to the device

Courtesy of Dan Olivier, Certified Software Solutions, Inc.

When is a 510(k) Required?• The device is introduced into commercial distribution for

the first time

• The device is in commercial distribution but is about to be “significantly changed or modified”:

– A change “that could significantly affect the safety or effectiveness of the device”

– A major change or modification in the intended use of the device

Note: The above is summarized from 21 CFR Part 807.81 “When a premarket notification submission is required”

Courtesy of Dan Olivier, Certified Software Solutions, Inc.

What is required for a 510(k)?

• General information:

– Definition of intended use in accordance with established product categories

– Comparison to “substantially equivalent” device

– Drawings

– Product overview

– Labeling

– Truth and accuracy statement

– Safety and effectiveness summary

Courtesy of Dan Olivier, Certified Software Solutions, Inc.

What is required for a 510(k)? (cont.)

• Supporting materials (attachments):

– Design specifications (safety risk analysis, requirements specification, design description, test procedures, …)

– Conformance to recognized standards (general safety standards such as UL, IEC, etc.)

– Clinical data to show performance or adherence to established “Guidance” requirements to demonstrate performance

– Reference materials if a not widely recognized method

Courtesy of Dan Olivier, Certified Software Solutions, Inc.

510(k) Review User Fees (U.S. Dollars)

Standard Fee Small Business Fee

FY2005 (Oct. 1, 2004 - Sept. 30, 2005) $3,502 $2,802

(<$30 million annual sales)

FY2006 (Oct. 1, 2005 - Sept. 30, 2006) $3,833 $3,066

(<$100 million annual sales)

FDA Fees for 510(k) Review

• 510(k) review• Supposed to be completed in 90 days• Mean time was 100 days in 2002

PMA: Premarket Approval• A required process of scientific review to ensure

the safety and effectiveness of most Class III devices

• … for which insufficient information exists to assure safety and effectiveness solely through general or special controls.

• An approved PMA application is a private license granted to the applicant to market a particular medical device.

• Submission-to-Decision time averaged 411 days in 2001.

FDA Fees for PMA

* PMA=Premarket Approval; PDP=Product Development Protocol; BLA=Biologics License Application; PMR=Premarket Report (for a reprocessed device)

FY 2006 Device Review User Fees (U.S. Dollars)

Type of Application Standard Fee

Small Business Fee

(<$100 million sales)

Premarket Application (PMA, PDP, BLA, PMR)*

NOTE: The fee is waived for the first premarket application from firms with gross receipts or sales <$30 million.

$259,600

$98,648

Premarket Report (PMR) - premarket approval application for a reprocessed device

$259,600 $98,648

Panel-track Supplement $259,600 $98,648

Efficacy Supplement (for BLA) $259,600 $98,648

180-day Supplement $55,814 $21,209

Real-time Supplement $18,691 $7,103

When can You “Market” a Medical Device?

• The device is “exempt” from premarket notification and has been listed with the FDA.

– Applies to most Class I devices and a few Class II devices

• The device has a “clearance” under the 510(k) program

– Applies to most Class II devices

• - or - the device has a “pending” clearance (FDA’s Compliance guide section 300.600):

– Although a firm may advertise a device that is the subject of a pending 510(k) a firm may not take orders that might result in contracts for sale unless limited to research or investigational use

• The device has an “approval” under the PMA program

– Applies to Class III devices

Courtesy of Dan Olivier, Certified Software Solutions, Inc.

Medical Devices are not only “Hardware”

Is Software a Medical Device?

• Software can be a device by itself (standalone), or it can be incorporated into another device, either as a component or part, or distributed separately for use as an accessory to another device.

1) Standalone Device• The FDA describes a standalone medical software

device as software that is neither a component nor an accessory which “is intended to receive medically related data as input and to output (relay) the results to a health care practitioner or other user.”[1]

• Examples of standalone software devices include:

– software that records medical information for later recall, analysis or action by a health care practitioner, or

– software designed to assist a health care practitioner in arriving at a diagnosis of a particular patient.[2]

[1] FDA Software Policy Workshop, FDA Regulation of Medical Device Software – Background Information, Points for Discussion, p. 3, August 28, 1995.

[2] Id.

2) Software Component

• A software component is “any ... software ...which is intended to be included as part of the finished, packaged and labeled device.”[3]

• Examples include software incorporated as a component of devices such as infusion pumps, pacemakers, ventilators, magnetic resonance imaging devices, etc.

[3] FDA Software Policy Workshop, FDA Regulation of Medical Device Software – Background Information, Points for Discussion, p. 3, August 28, 1995.

3) Software Accessory• A software accessory is a “unit which is intended to be attached to or used in

conjunction with another finished device, although an accessory may be sold or promoted as an independent unit.” – Typically, software accessories are marketed as finished devices and not

necessarily by the same manufacturer who produces the parent hardware device.

• In determining whether software is an “accessory,” the FDA evaluates the intended use of the software. – If the answer to either of the following two questions is “Yes,” the FDA has

generally ruled that the software is an accessory, subject to the same level of regulation as the parent device.[4]

• Is the software specified or otherwise intended for use with a medical device?• Is the software directly interfaced with another medical device for transfer of data to

and from the other device?

• Examples include conversion of pacemaker telemetry data, conversion, transmission or storage of medical images, off-line analysis of EEG data, digital analysis and graphical presentation of EEG data.

[4] FDA Software Policy Workshop, Points for Discussion: Background, page 3.

Quality System Regulations(QSR)

“Without documentation of the existence of quality processes

and the verification that the processes are executed during

product development, new healthcare products will not gain approval in the United States or

be able to be sold in major overseas markets.”

E. Whitmore, Development of FDA-Regulated Medical Products, American Society for Quality, 2004.

cGMP

• Current Good Manufacturing Practice• Quality must be designed and built into a product.

• Device cGMPs are known as Quality System Regulations (QSR)

• Emphasis on “quality” facilitates harmonization with international standards

CFR, Title 21

• The FDA is mandated to enforce Title 21 of the United States Code (21 U.S.C) as amended.

• Chapter I of Title 21 Food and Drugs of the Code of Federal Regulations (CFR) is composed of parts 1-1299 which are specific to the Food and Drug Administration (published in 8 volumes)

21 CFR Parts 1-1299• 21 CFR 801

– Labeling

• 21 CFR 803– Medical Device Reporting

• 21 CFR 807– Establishment Registration and Device Listing for Manufacturers

and Distributors of Devices

• 21 CFR 814– Premarket Approval of Medical Devices

• 21 CFR 820– Quality System Regulations– Consists of 15 subparts and 31 sections.

21 CFR Part 820Subpart A – General ProvisionsSubpart B – Quality Systems RequirementsSubpart C – Design ControlsSubpart D – Document ControlsSubpart E – Purchasing ControlsSubpart F – Identification and TraceabilitySubpart G – Production and Process ControlsSubpart H – Acceptance ActivitiesSubpart I – Nonconforming ProductSubpart J – Corrective and Preventive ActionSubpart K – Labeling and Packaging ControlSubpart L – Handling, Storage, Distribution and InstallationSubpart M – RecordsSubpart N – ServicingSubpart O – Statistical Techniques

Subpart B: Quality System Requirements

• Quality Policy to establish policy, objectives, and commitment to quality (820.20)

• Management reviews are required by designated management representative (820.20)

• Quality audits are to be conducted by individuals who do not have direct responsibility for matters audited (820.22)

• Identify training needs, ensure all personnel are trained, and document training (820.25)

Courtesy of Dan Olivier, Certified Software Solutions, Inc.

Subpart C: Design Controls• Procedures must be established to define the development process

• Developmental phases must have deliverable products (specifications)

• The development process must consist of sequential phases that build on previous phases

• Reviews must be documented for major milestones and specifications

• Individual responsibility for design activities must be identified

• Documents and code must be maintained under a change control system

Courtesy of Dan Olivier, Certified Software Solutions, Inc.

Why Product Development?

• FDA determined that about 40% of medical device recalls were attributable to design defects

• Bad designs become bad products

• Design phase is the most important phase with regard to the lifecycle of a device.

• Established inherent safety, effectiveness, and reliability

The 1-10-100 RuleCost of preventing a defect before it occurs

Cost of correcting a defect before it reaches a customer

Cost of correcting a defect after it reaches a customer

1

10

100

FDA QSR and ISO 9000• FDA regulations are required by Federal law.

• ISO 9000 is a set of voluntary quality standards

• FDA’s management responsibility is more clearly defined and specific than ISO 9000.

• ISO 9000 has no requirements for failure reporting, recall, safety or effectiveness.

• FDA has limited control over the Personnel, Finance, Sales, and Marketing departments

• ISO 9000 expects these to be fully controlled

Are Telehealth Programs becoming

unintentional manufacturers

of Medical Devices?

Any person who connects external equipment to signal input and signal output parts or other connectors has formed a system and is therefore responsible for the system to comply with the requirements of IEC 601-1-1.

Text from a Users Manual

Are you affected?• Are you fully compliant with the labeling of your

medical equipment?

• Do you purchase devices and/or software and use them for unintended medical purposes?

• Do you assemble components from manufacturers and distribute them to sites?

• Are you developing software that qualifies as a Medical Device?

ReferencesCDRH Home Page: http://www.fda.gov/cdrh/

QSIT Website: www.fda.gov/cdrh/gmp/gmp.html

QSIT Study: www.fda.gov/cdrh/gmp/qsit-study.pdf

QSIT “Guide”: www.fda.gov/cdrh/gmp/qsitbook.html

cGMP/ Quality Systems: http://www.fda.gov/cdrh/comp/gmp.html

Frequently Asked Questions on the New 510(K) Paradigm: http://www.fda.gov/cdrh/ode/92_a.html

Search the Releasable 510(k) Database: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

List of Devices for Third Party Review under the FDA Modernization Act of 1997: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm?panel=RA#TopPage

Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203): http://www.fda.gov/cdrh/dsma/470.pdf

Write it Right: http://www.fda.gov/cdrh/dsma/897.pdf

ReferencesDevice Labeling Guidance #G91-1 (blue book memo)

http://www.fda.gov/cdrh/g91-1.html Guidance on Medical Device Patient Labeling; Final Guidance for

Industry and FDA Reviewershttp://www.fda.gov/cdrh/ohip/guidance/1128.html http://www.fda.gov/cdrh/ohip/guidance/1128.pdf

Guidance on Labeling for Laboratory Tests; Drafthttp://www.fda.gov/cdrh/ode/1352.html http://www.fda.gov/cdrh/ode/1352.pdf

Human Factors Principles for Medical Device Labelinghttp://www.fda.gov/cdrh/dsma/227.html

ISO 13485 Medical Device Standard in Plain English: http://praxiom.com/iso-13485.htm

Certified Software Solutions, Inc.: http://www.certifiedsoftware.com/services/services.htm

Thank You

AFHCAN, Alaska Native Tribal Health Consortium, Anchorage, AK