FDA Medical Device Rules

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FDA Medical Device Rules

• Robert F. Munzner, Ph.D.
• www.DoctorDevice.com

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The Law

• F. D. C. Act (1938)
• Radiation Health and Safety Act (1968)
• Medical Device Amendments (1976)
• Safe Medical Devices Amend. (1990)
• FDA Modernization, User Fees

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Legal Interpretation
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What is a Medical Device ?

• Defined by Law

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Definition of Device

• -- Physical Device (Hardware)
• -- Intended Use (Medical)
• -- but not a drug

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Hardware

• instrument,
• apparatus,
• implement,
• machine,
• contrivance,
• and etc.,
• or any part, accessory ...

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Intended

• for diagnosis of disease
• for treatment of disease
• to affect structure/function of the body

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FDA Mandate

• Assure that Medical Devices
• are Safe and Effective

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What is Safe

• Risk
• Benefit

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Safe

• Benefits outweigh Risks

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Benefit

• -- implies effectiveness can be measured

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Effectiveness

• -- for what need or condition
• (Indications)
• -- for whom what circumstances
• (Intended Use)

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Device Classes

• Class I -- General Controls (apply to all)
• Class II -- Special Controls
• (aka Standards)
• Class III -- Premarket Approval

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To Sell
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NEW DEVICES
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New but Similar
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Substantially Equivalent

• Submit a 510(k) notice to FDA that shows new
  device is comparable to marketed devices
• FDA examines 510(k) and makes the determination
  of SE

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510(k)

• Notice of intent to market
• Description of the Device
• Comparison with a Predicate Device

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510(k) Contents

• there is no form per se
• generally described in 21 CFR 807.87
• FDA provides specific guidance
• Checklist is available

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21 CFR 800

• Title 21, Code of Federal Regulations
• Parts 800 1200, medical device rules
• Every classified device described
• www.access.gpo.gov
• /su_docs/aces/aces140.html

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FDA Guidance Documents

• Are not legal requirements
• Intended to help 510(k) prep
• Not available for every device
• www.cdrh.fda.gov/guidance

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Check List

• Used for Refuse to File
• Includes some necessary administrivia
• Hard to find from web site
• (see hard copy)

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FDA Response

• May take up to 90 days
• SE Letter allows marketing
• More Info Needed Letter
• May take another 90 days after reply
• Cannot Determine Letter
• clinical data required
• NSE Letter PMA may be required

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Device Classification

• Same as the equivalent predicate
• If not SE to predicate, de novo classification
  is possible
• If NSE and Class III, PMA required

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Class I Devices

• Typically manual instruments, etc.
• May be exempt from 510(k)
• May be exempt from GMP
• Few Site Inspections
• Subject only to General Provisions

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General Provisions

• Premarket Notification 510(k)
• 510(k) for modifications
• Good Manufacturing Practice Rules
• Inspections for GMP Compliance
• Truth in Labeling
• Adequate Instructions or Rx

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Class II Devices

• May be subject to special requirements
  (specified in FR or CFR)
• Performance Standard may apply (few)
• Site inspections every two years
• General Provisions Also Apply

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Class III Devices

• Frequent, Thorough Site Inspections
• Class I and Class II Rules Apply Also
• May be required to file PMA
• Reclassification possible