Entering the US Market: Medical Devices

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30 Νοε 2013 (πριν από 3 χρόνια και 8 μήνες)

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Entering the US Market:
Medical Devices

Carole C. Carey BSEE, M.Engineering

carole.carey@fda.hhs.gov

Director, International Staff

US Food and Drug Administration

Center for Devices and Radiological Health

2

Topics


Brief FDA Organizational Structure


Regulatory Paradigm, Device Classification


Two Most Common Pathways to Market


Levels of Regulatory Control (General Controls &
Special Controls)


Importing into the U.S.


CDRH Databases and Resources






3

The U.S. Food and Drug
Administration is


Scientific, Regulatory, Public Health Agency



Mission is to
protect and promote public health
.

http://www.fda.gov/



Authority to regulate medical devices


Federal FD&C Act


Established regulatory controls for
medical devices (May 28, 1976)


21 CFR Parts 800
-
1299

4

Department of Health & Human
Services


5

FDA Centers

and Regulated Products


Food


Drugs



Medical Devices

*


Biologics


Animal Feed and Drugs


Cosmetics


Radiation
-
Emitting
Products

*


Combination Products

(
drug
-
device
*
,
biologic
-
device
*
,
drug
-
biologic)


Primary mode of action


RFD (Request for
Designation)


CDER


Center for Drugs and

Evaluation Research


CVM

Center for

Veterinary Medicine


NCTR

National Center

for Toxicological Research

CFSAN

Center for Food Safety

and Applied Nutrition

CBER


Center for Biologics and

Evaluation Research

CDRH

Center for Devices

and Radiological Health

FDA

*

Office of Regulatory Affairs (
ORA
)

is the lead office for all field activities.


6



Center Director

Dr. Daniel Schultz

Office of Device Evaluation ODE

Office of Compliance (OC)

Office of Science and

Engineering Laboratories (OSEL)

Office of Surveillance

and Biometrics (OSB)

Office of Communication,

Education and Radiation Programs

(OCER)

*
International Affairs

Office of In Vitro Diagnostic

Device Evaluation and Safety (OIVD)

http://www.fda.gov/cdrh/index.html

CDRH

7

16 Classification Regulations

21 CFR (part 800
-
1299)


Clinical chemistry and
clinical toxicology


Hematology and
pathology


Immunology and
microbiology


Anesthesiology


Cardiovascular


Dental


Ear, nose and throat


Gastroenterology &
urology devices


General and plastic
surgery


General hospital and
personal use


Neurological


Ophthalmic


Orthopedic and physical
medicine


Obstetrical and
gynecological


Radiology


Medical Device Definition in Sec 201(h)
of the FD&C Act

8

Regulatory Paradigm:
Balancing Risks and Benefits

Getting
safe
and effective
devices

to
market as
quickly as
possible…

… while
ensuring that
devices
currently on
the market
remain
safe
and effective
.

Helping the public get
science
-
based accurate
information

about medical devices and radiological
products needed to improve health.

9

Risk
-
based Classification, Level of
Reg Control, & Submission Type

510(k)
Exempt

Class I

Class II

Class III

Very low

Low (~782)

Medium
(~799)

High (~119)

General Controls
(may or may not
be GMP exempt)

General Controls

Premarket
Notification or
510(k)

General & Special
Controls

510(k)
submission

General & Special
Controls

Premarket
Approval

1700 generic type of devices

Level of Risk & Level of Regulatory Control


10

Class I / II Exemptions

FD&C Act 513(d)(2A)


Over 800 generic types of Class I devices

and 60 Class II devices are exempted from the
premarket notification requirement (
Federal Register)



510(k) Exempt Devices
-

approximately 47%



Class I


93%



Class II


9%



Devices exempt from 510(k) are:


“preamendment devices” not significantly changed
or modified; or


Class I/II devices specifically exempted by
regulation.

http://www.fda.gov/cdrh/devadvice/3133.html

11

Examples of Device Classes

Medical Device Classes:


Class I

General Controls

Most exempt from premarket submission


Class II


Special Controls

Premarket Notification [510(k)]


Class III


Require Premarket Approval [PMA]

12

What are General Controls?


Basic authorities that
provide FDA with the
means to regulate
medical devices.


Applies to
all medical
devices

regardless of
classification, are
subject to premarket
and postmarket
regulatory controls.





Establishment
registration and device
listing


Premarket notification or
510(k), if not exempt


Labeling


Misbranding


Adulteration


Quality Systems


Records and Reports /
Medical Device Reporting
(MDR)


13

What are Special Controls?


Postmarket Surveillance
Study


Patient Registries


Guidelines (e.g., Glove
Manual)


Mandatory Performance
Standard


Recommendations or
Other Actions


Special Labeling (e.g.,
882.5970, Cranial
Orthosis)




General controls alone are
insufficient to assure safety
and effectiveness of Class II
devices



Existing methods are
available to provide such
assurances.



Special controls may include
special labeling requirements,
mandatory performance
standards and postmarket
surveillance.



A few Class II devices are
exempt from the premarket
notification.


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Two Most Common Pathways to
Market in the U.S.


Premarket Notification (PMN or 510(K))


Safe and effective to a legally marketed (predicate) device
through demonstration of substantial equivalence


Class I, II, or III (pre
-
amendment)



Premarket Approval (PMA)


Demonstration of safety and effectiveness (supported by
clinical data)


Class III (new, high risk devices and no predicate device,
new indications)



The
primary regulation

that allows to conduct clinical
trials using unapproved medical devices in the U.S.
without complying with the FD&C Act is…


the
IDE or Investigational Device Exemption

(21 CFR
Part 812)



15

Use of Consensus Standards &
Guidance Documents


CDRH Standards Program


http://www.fda.gov/cdrh/stdsprog.html



Guidance Documents


http://www.fda.gov/cdrh/guidance.html


They are non
-
binding but very useful in
streamlining the regulatory approval
process.


16






Legal Import of Medical Devices
into the U.S. Market


Section 801(a)


(d) of the FD&C Act


Subject to examination
by FDA even if the
product is authorized for
marketing in another
country.


Devices must be safe
and effective.


Must contain informative
and truthful labeling in
English.


Imported products are
required to meet the
same standards as
domestic goods.



Establishment
Registration


Medical Device Listing


Compliant Labeling


GMP/Quality Systems


Appropriate Marketing
Applications unless
exempt


510(k)


PMA


Adverse Event Reporting,
Records/Complaint Files


17

Summary


If a product is labeled, promoted or used in a manner defined in
section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act,
it will be regulated by the FDA as a
medical device
.



USFDA CDRH’s regulatory paradigm is risk
-
based classification.
The levels of regulatory control are based on the classification.
Unless exempt, they require a premarket notification clearance
or a premarket approval application.



In entering the U.S. medical device market,


First determine if it meets definition of medical device.


Then determine how the may FDA classify the device, if known.


Finally, gather your information, collect the necessary data, organize
your submission.



Products imported into the U.S. meets the same standards and
requirements as domestic goods.




18

CDRH manages risk across the

“Total Product Life Cycle” applied
across Center activities

Enabling

Technology

and Innovation

Efficient,

Effective,

and Predictable

Product

Development

Ensuring

the Safety of


Marketed

Medical Devices

19

CDRH Databases

http://www.fda.gov/cdrh/databases.html


Registration and Listing


Premarket Approvals (PMA)


Premarket Notifications (510(k))


Product Classification


FDA
-
Recognized Consensus Standards


MAUDE (Manufacturer and User Facility
Device Experience)


MDR (Medical Device Reporting) ’92
-
’96


and others…


20

Division of Small Manufacturers,
International

and Consumer Assistance (DSMICA)




E
-
mail:


dsmica@cdrh.fda.gov


Fax


(00)1
-
240
-
276
-
3151


Phone

(00)1
-
240
-
276
-
3150




Write to us at:


International Staff, Center for Devices

and Radiological Health, HFZ
-
220

1350 Piccard Drive

Rockville, MD 20850 USA




“Device Advice” (a self
-
service, interactive Site)

http://www.fda.gov/cdrh/devadvice/