FDA CDRH Organizational Structure Overview by peisty474

VIEWS: 169 PAGES: 20

									 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
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




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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




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Department of Health & Human
Services




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    FDA Centers
    and Regulated Products

 Food                                                          *
                                                               CDRH
 Drugs                                                  Center for Devices
                                                       and Radiological Health
 Medical Devices *
  Biologics
                                             CDER                                  CBER
                                     Center for Drugs and                Center for Biologics and

  Animal Feed and Drugs
                                      Evaluation Research                   Evaluation Research

 Cosmetics                                                    FDA
 Radiation-Emitting
  Products *                                 CVM                                   CFSAN
                                          Center for                       Center for Food Safety
 Combination Products                Veterinary Medicine                  and Applied Nutrition

  (drug-device*, biologic-                                       NCTR
  device*, drug-biologic)                                   National Center
                                                      for Toxicological Research
       Primary mode of action
       RFD (Request for
        Designation)             Office of Regulatory Affairs (ORA)
                                 is the lead office for all field activities.
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    CDRH
                               Center Director
                              Dr. Daniel Schultz


Office of Device Evaluation ODE                Office of Compliance (OC)


     Office of Science and                         Office of Surveillance
Engineering Laboratories (OSEL)                    and Biometrics (OSB)

     Office of Communication,
 Education and Radiation Programs
                                               Office of In Vitro Diagnostic
  (OCER) *International Affairs
                                           Device Evaluation and Safety (OIVD)


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


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16 Classification Regulations
21 CFR (part 800-1299)


 Clinical chemistry and     General and plastic
  clinical toxicology         surgery
 Hematology and             General hospital and
  pathology                   personal use
 Immunology and
  microbiology               Neurological
 Anesthesiology             Ophthalmic
 Cardiovascular             Orthopedic and physical
 Dental                      medicine
 Ear, nose and throat       Obstetrical and
 Gastroenterology &          gynecological
  urology devices            Radiology

     Medical Device Definition in Sec 201(h)
     of the FD&C Act                                    7
  Regulatory Paradigm:
  Balancing Risks and Benefits
                                         … while
Getting safe                        ensuring that
and effective                             devices
devices to                           currently on
market as                             the market
quickly as                           remain safe
possible…                           and effective.

    Helping the public get science-based accurate
 information about medical devices and radiological
         products needed to improve health.

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 Risk-based Classification, Level of
 Reg Control, & Submission Type
                      1700 generic type of devices



510(k)              Class I            Class II            Class III
Exempt
Very low            Low (~782)         Medium              High (~119)
                                       (~799)
General Controls    General Controls   General & Special   General & Special
(may or may not     Premarket          Controls            Controls
be GMP exempt)      Notification or    510(k)              Premarket
                    510(k)             submission          Approval




                   Level of Risk & Level of Regulatory Control           9
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

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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]



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What are General Controls?
                                Establishment
   Basic authorities that       registration and device
    provide FDA with the         listing
    means to regulate           Premarket notification or
    medical devices.             510(k), if not exempt
   Applies to all medical      Labeling
    devices regardless of       Misbranding
    classification, are         Adulteration
    subject to premarket        Quality Systems
    and postmarket              Records and Reports /
    regulatory controls.         Medical Device Reporting
                                 (MDR)



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What are Special Controls?
   Postmarket Surveillance      General controls alone are
    Study                         insufficient to assure safety
                                  and effectiveness of Class II
   Patient Registries            devices
   Guidelines (e.g., Glove
                                 Existing methods are
    Manual)                       available to provide such
   Mandatory Performance         assurances.
    Standard
                                 Special controls may include
   Recommendations or            special labeling requirements,
                                  mandatory performance
    Other Actions                 standards and postmarket
   Special Labeling (e.g.,       surveillance.
    882.5970, Cranial             A few Class II devices are
    Orthosis)                     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)

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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.


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Legal Import of Medical Devices
into the U.S. Market
Section 801(a) – (d) of the FD&C Act

 Subject to examination       Establishment
  by FDA even if the            Registration
  product is authorized for    Medical Device Listing
  marketing in another         Compliant Labeling
  country.
                               GMP/Quality Systems
 Devices must be safe
  and effective.               Appropriate Marketing
                                Applications unless
 Must contain informative      exempt
  and truthful labeling in
                                    510(k)
  English.
                                    PMA
 Imported products are
  required to meet the         Adverse Event Reporting,
  same standards as             Records/Complaint Files
  domestic goods.

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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.
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CDRH manages risk across the
“Total Product Life Cycle” applied
across Center activities

                      Efficient,
                      Effective,
                   and Predictable
                      Product
                    Development




    Ensuring
                                       Enabling
  the Safety of
                                      Technology
    Marketed
                                     and Innovation
 Medical Devices

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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…
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     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/

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