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Presentation: Overview of Regulatory Requirements- Medical Devices

(This presentation is also available in video format with captioning and PDF printer-friendly format.)

William (Bill) M. Sutton
Deputy Director
Division of Small Manufacturers, International
and Consumer Assistance
Center for Devices and Radiological Health

• Department of Health and Human Services
  Secretary
  • Public Health Service
    Surgeon General
    • National Institutes of Health
    • Health Resources and Services Administration
    • Agency for Health Care Research and Quality
    • Indian Health Service
    • Substance Abuse and Mental Health Administration
    • Centers for Disease Control
    • Food and Drug Administration
      

U.S. Food and Drug Administration

• Commissioner
  • Center for Food Safety & Applied Nutrition (CFSAN)
  • Center for Drug Evaluation & Research (CDER)
  • Center for Biologics Evaluation & Research (CBER)
  • Center for Devices & Radiological Health (CDRH)
  • Center for Veterinary Medicine (CVM)
  • Office of Regulatory Affairs (ORA)

Center for Devices and Radiological Health (CDRH)

• Daniel G. Schultz, M.D.
  Director
  • Office of Compliance
  • Office of Device Evaluation
  • Office of Communication, Education and Radiation Programs
  • Office of Science and Engineering Technologies
  • Office of Surveillance and Biometrics
  • Office of In Vitro Diagnostic Device Evaluation and Safety

FDA Authority to Regulate Federal Food Drug and Cosmetic Act (FD&C Act)

• Medical Device Amendments
  • May 28, 1976
• Regulations implementing FD&C Act
  • Title 21 Code of Federal Regulations (21CFR) Parts 800 - 1299

Definition of a Medical Device - Section 201(h) of the FD&C Act

• Diagnosis, cure, mitigation, treatment or prevention of disease or condition
• Affects the structure or function of the body
• Does not achieve intended use through chemical reaction
• Is not metabolized to achieve effect

There are a Wide Variety of Medical Devices Regulated by the U.S. FDA…

• General Purpose Reagent
• Electrocardiograph
• Latex Patient Examination Glove
• Piston Syringe
• Endoscope
• Dental Floss
• Replacement Heart Valve

What is FDA’s focus?

• Ensuring that medical devices are “reasonably” safe and effective.

Device Classification

• 1700 generic types of devices
• 16 classification regulations
  • 21 CFR 862-892
    • e.g. 870 = Cardiovascular
• Classification determines extent of regulatory control

Device Classification

• Regulation Number - 880.2910
• Classification Name - Electronic Thermometer
• Classification Number / Product Code - FLL
• Device Class / Risk Categorization - II

Classification System / Risk Categorization

• Class I
  • General Controls
• Class II
  • General Controls and
  • Special Controls
• Class III
  • General & Special Controls and
  • Premarket Approval

General Controls

• Adulteration / Misbranding
• Electronic Establishment Registration
• Electronic Device Listing
• Premarket Notification [510(k)]
• Quality Systems
• Labeling
• Medical Device Reporting (MDR)

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)

Establishment Registration & Medical Device Listing
(21 CFR Part 807)

• Electronic Registration of Medical Device Establishment
  • Notification of U.S. Agent for Foreign Establishments
• Electronic Medical Device Listing
• www.fda.gov/cdrh/reglistpage.html

Premarket Notification 510(k) 
(21 CFR Part 807)

• Marketing Clearance Process
• No form - Application submitted at least 90 days before marketing.
• Demonstration of Substantial Equivalence (SE) to legally marketed device in U.S.
• SE means “As safe and as effective”

510(k) Required When

• Marketing for First Time, or
• Significant Change to Existing Device

510(k) Exempt Devices - 798 / 47%

Class I - 729 / 93%
Class II - 69 / 9%

Changes to 510(k) Program

• Third Party Program (Accredited Persons)
• Special 510(k) - use of Design Controls to assure SE for device modifications
• Abbreviated 510(k) - Conformance with Recognized Standards to reduce data

510(k) Device User Fees

• For fiscal year 2008 (October 1, 2007 through September 30, 2008), the fee for a 510(k) review is the following in U.S. Dollars:
• Standard Fee $3,404
• *Small Business Fee $1,702
  • * (≤$100 million in gross receipts or sales)

Premarket Approval (PMA) 
(21 CFR Part 814)

• Only applies to Class III devices
• Classification requires PMA
• Device found Not “SE” or “NSE”
• “New” - no basis for “SE”
• Proof of Safety and Effectiveness with clinical data

PMA Device User Fees 
“Original Application”

• For fiscal year 2008 (October 1, 2007 through September 30, 2008), the fee for a PMA review is the following in U.S. Dollars:
• Standard Fee $185,000
• Small Business Fee for First Application
• ≤$30 million in gross receipts or sales - Fee is Waived
  ≤$100 million in gross receipts or sale - $46,250

Investigational Device Exemption(IDE)
 “Clinical Trials”
(21 CFR Part 812)

• Unapproved Devices
• Used on human subjects to collect safety and effectiveness data
• Protection of human subjects

Medical Device Labeling
 (21CFR Part 801, 809, 812, 820)

• Any label or written material on the device or material that accompanies the device
• Labeling must provide adequate directions for use unless exempt
• Labeling must not be false or misleading

Quality System (QS) Regulation
(21 CFR Part 820)

Quality Assurance System covering the design and manufacture of medical devices sold in the U.S.

• Similar to ISO 13485
• Standard for audit of device establishment

Medical Device Reporting (MDR)
 “Adverse Event Reporting”
(21 CFR Part 803)

• Mechanism for FDA to identify and monitor significant adverse events involving medical devices

Events: Death, Serious Injury and Malfunction

Reported by: Manufacturer, User Facility, and Importers of medical devices

Postmarket Surveillance

• Postmarket Studies for various permanent implants after approval to monitor unexpected problems
• Device Tracking - system for locating permanent implants/life-sustaining devices after they leave the hospital

Food and Drug Administration Amendments Act of 2007 (FDAAA)

Medical Device Provisions

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

Fees Related to Medical Devices
 “Existing”

• Premarket Applications (PMA, PDP, BLA, PMR)
• Panel-track PMA Supplements
• BLA Efficacy Supplements
• 180-Day PMA Supplements
• Real-time PMA Supplements
• 510(k) Premarket Notification

New Types of Fees

• Establishment Registration (To account for 45% of User Fees)
• 513(g) Request
• 30-Day Notice
• Periodic Reporting on a Class III Device

Small Business Determination

• Both domestic (U.S.) and foreign businesses may qualify as a small business in FY2008.
• Gross receipts or sales $100 million or $30 million for free/reduced PMA.
• U.S. firms (domestic) file using FDA-3602
• Foreign firms file using FDA-3602A
  • National Taxing Authority

Electronic Registration and Listing System

• Annual Registration Fee
  • Manufacturer
  • Single-use reprocessor
  • Specification developer
• $1,706 U.S. Dollars for 2008
• No Discount for Small Business

Other Provisions

• Requires establishment of unique device identification system
• Streamlines Inspection by Accredited Persons
• Promotes development of pediatric devices
• FDAAA sunsets on October 01, 2012

CDRH Homepage

• www.fda.gov/cdrh
  • 510(k) Releasable Database
  • Device Classification Database
  • Device Advice
  • Register for “What’s New”
  • Guidance Documents
  • Much more…

Need Assistance?

Division of Small Manufacturers, International and Consumer Assistance (DSMICA)

• www.fda.gov/cdrh/industry/support/
• Email: DSMICA@FDA.HHS.GOV
• Fax: 240-276-3151
• Phone: 240-276-3150

Updated November 12, 2008

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