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Download EMBS 2004 Conference Presentation
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FDA Medical Device Rules Robert F. Munzner, Ph.D. www.DoctorDevice.com “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 Legal Interpretation: LAW (Act of Congress) Regulations (FDA) FDA Orders (by letter) What is a Medical Device ? Defined by Law Definition of Device -- Physical Device (Hardware) -- Intended Use (Medical) -- but not a drug Hardware instrument, apparatus, implement, machine, contrivance, and etc., or any part, accessory ... Intended : for diagnosis of disease for treatment of disease to affect structure/function of the body FDA Mandate: Assure that Medical Devices are Safe and Effective What is “Safe” Risk Benefit Safe: Benefits outweigh Risks Benefit: -- implies effectiveness can be measured Effectiveness: -- for what need or condition (Indications) -- for whom & what circumstances (Intended Use) Device Classes Class I -- General Controls (apply to all) Class II -- Special Controls (aka Standards) Class III -- Premarket Approval To Sell: New Device Similar to another device REALLY New NEW DEVICES REALLY NEW (not substantially equivalent) IDE (Clinical Data) Premarket Approval Application (PMA) “New” but Similar Device Similar to Others 510(k) Notification FDA Determination: "Substantially Equivalent" MARKET “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 510(k) Notice of intent to market Description of the Device Comparison with a “Predicate” Device 510(k) Contents there is no “form” per se generally described in 21 CFR 807.87 FDA provides specific “guidance” Checklist is available 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 FDA Guidance Documents Are not legal requirements Intended to help 510(k) prep Not available for every device www.cdrh.fda.gov/guidance Check List Used for “Refuse to File” Includes some necessary administrivia Hard to find from web site (see hard copy) 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 Device Classification Same as the “equivalent” predicate If not SE to predicate, de novo classification is possible If NSE and Class III, PMA required 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 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 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 Class III Devices Frequent, Thorough Site Inspections Class I and Class II Rules Apply Also May be required to file PMA Reclassification possible
