Medical Device Classification The Key to Getting a Product on the Market with thanks to... David A. Pettenski, Supervisory Investigation Goals Understand why there is a medical device classification system Identify the medical device classes Understand the differences between regulatory requirements Learn the basic marketing approval process for medical devices How to determine a medical device class U.S. Food & Drug Administration 1 2 Origin of Classification System Medical Device Amendment to the FD&C Act of 1976 May 28, 1976 Provided classification for regulatory purposes A priority of control/oversight Early form of risk based approach Designation of Controls to Mitigate Risk Basis for Classification of Devices Amount of information known about device for intended use & indications for use Scalpel: intended use - cut tissue. Indication in labeling "for making incisions in the cornea". What level of controls are necessary to assure Safety & Effectiveness of device Support or sustain human life OR important in preventing impairment of human health Risk of causing illness or injury 3 4
Preamemdment vs Postamendment Devices FD&C Act (Medical Device Amendment May 28, 1976) divided arena of medical devices into either: Preamendment Devices or Postamendment Devices Depending upon when the devices were introduced into commercial distribution Intent to classify all products on the market Pre May 28, 1976 Products Preamendment Device Exempted (with conditions) from marketing clearance Preamendment Status Determinations: www.fda.gov/cdrh/comp/preamend.html Class I and II No 510(k) required Class III No PMA required until called for Marketed with a 510(k) 5 6 Post May 28, 1976 Products Post amendment Device Requires marketing clearance Automatic Class III Introduced onto market after May 1976 Not substantially equivalent to a pre-may 1976 device Not already Classified as I or II Classification Process Establish Panels of Experts by device area FDA refers products to Panels for review Panel Review & Recommendation FDA publish in Federal Register for comments Final Classification Federal Register Code of Federal Regulations 7 8
Medical Device Classification & Regulatory Requirements Class I - General Controls (with & w/o exemptions) Class II General Controls and Special Controls (with & w/o exemptions) Class III General Controls and Premarket Approval Class I - General Controls Known information provides reasonable assurance of safety & effectiveness using General Controls OR Known information does not assure S & E, BUT the device Does not support or sustain human life, OR Is not used to prevent impairment of human health AND No unreasonable risk of illness or injury 9 10 General Controls General Controls FD&C Act Section 510 FD&C Act Sec. 510: Registration, Listing, 510(k) FD&C Act Sec. 518: Notification & Other Remedies FD&C Act Sec. 519: Records & Other Reports (MDR, Tracking. Corrections/Removals) Establishment Registration Product Listing 510(k) - Premarket Notification, unless exempt FD&C Act Sec. 520: General Provisions (GMPs/QSR) 11 12
General Controls FD&C Act Section 518 General Controls FD&C Act Section 519 Notification Medical Device Reporting Repair, Replace, or Refund Device Tracking (as required) Recall Authority Reports of Removals and Corrections 13 14 General Controls FD&C Act Section 520 Good Manufacturing Practices/Quality System Regulations, unless exempt Design Controls (as applicable) All class II & III medical devices plus the five class I devices listed in 21 CFR 820.30 Examples of Class I Devices Examination Gloves 21CFR880.6250 Dental Hand Instrument 21CFR872.4565 Elastic Bandages 21CFR880.5075 Pacemaker Charger 21CFR870.3670 Ultrasonic Cleaner for Medical Instruments 21CFR880.6150 Hand-held (Manual) Surgical Instruments 21CFR878.4800 15 16
Class II - Special Controls General Controls alone are insufficient to provide assurance of Safety & Effectiveness BUT Information exists to establish Special Controls Special Controls General Controls + Special Labeling Requirements Performance Standards Postmarket Surveillance Patient Registries Guidelines Recommendations Any other appropriate actions 17 18 Examples of Class II Devices Cardiac Monitor 21CFR870.2300 Elbow Joint Metal/Polymer Constrained Cemented Prosthesis 21CFR888.3150 Pediatric hospital bed 21CFR880.5140 Infusion Pump 21CFR880.5725 Powered Wheelchair 21CFR890.3860 Surgical Drapes 21CFR878.4370 TENS device 21CFR882.5890 Class III - Premarket Approval Not enough information to classify as either Class I or II Device usually supports/sustains life, is of substantial importance in preventing impairment of human health or presents a potential, unreasonable risk of illness or injury 19 20
Premarket Approval Extensive submission including data showing Safety & Effectiveness Conditions of Approval Annual Reports Examples of Class III Devices Implantable 21CFR870.3610 Replacement heart valve 21CFR870.3925 Cranial electrotherapy 21CFR882.5800 Implanted electrical urinary continence device 21CFR876.5270 Silicone gel-filled breast implant 21CFR878.3540 Implanted cerebella stimulator 21CFR882.5820 21 22 Unclassified Device What regulations apply? Similar product for same intended use already on market or is it brand new? Product Classification Database Search: infusion http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/pcdsimplesear ch.cfm 513(g) Request for Information Request for device status, classification & regulatory requirements applicable to a device Submitted, via mail only. No fees. 60 day response. The 513(g) request should include: A cover letter stating the submission is a 513(g) request. Indicate the contact person's name, address, telephone number and fax number. A detailed description of product/device. A concise Indication(s) for Use Statement. Either proposed labeling or labeling of a marketed similar device. If no labeling is available, note in cover letter. 23 24
513(g) Request for Information Submit the 513(g) request to the following address: 513(g) Coordinator c/o Document Mail Center (HFZ-401) Office of Device Evaluation Center for Devices and Radiological Health 9200 Corporate Boulevard Rockville, MD 20850 FDA response to a request for information concerning classification or regulatory requirements is not a "determination" or a classification of a product/device. Classification of a device is accomplished by going through the premarket notification [510(k)] process. Our response to a 513(g) request is our opinion on the device status and regulatory requirements applicable to a product/device. Substantial Equivalence Key element in a 510(k) Establish Equivalence to: A legally marketed device (a predicate*) that does not require a PMA, i.e., a: Preamendments device* A device found by FDA to be Substantially Equivalent (SE), or A reclassified device* *21 CFR 807.92(a)(3) 25 30 Device is Substantially Equivalent (SE) if: In Comparison to a legally marketed device*, it: Has the same intended use, and Has the same technological characteristics as the predicate device, or: Device is Substantially Equivalent (SE) if: Has the same intended use, and Has different technological characteristics and the information in the 510(k): Does not raise new questions of safety and effectiveness, and Demonstrates it is at least as safe and effective as the predicate Approximately 80% are found SE 31 32
Device is Not Substantially Equivalent (NSE) if: There is no predicate device Has a new intended use Has different technological characteristics compared to the predicate device and raises a new type question of safety and effectiveness Does not demonstrate that it is at least as safe and effective as the predicate Not Substantially Equivalent (NSE) 2 3% are found NSE Data is looked at last in the 510(k) regulatory process Usually ask for additional information at least once prior to determining the device is NSE for lack of data 33 34 Finding a Classified Product References A device that delivers an electrical shock for restoring normal heart rhythm: DC-defibrillator Product Classification Database Search http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/pcdsimplesearch.cf m Device Classification Panels http://www.fda.gov/cdrh/devadvice/3131.html 510(k) Premarket Notification Database Search: Lifepak 9 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm Establishment Registration Database Search: Medtronic ERS Inc http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/registration.cfm Device Listing Database Search: 3015876 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/listing.cfm Classify Your Medical Device (http://www.fda.gov/cdrh/devadvice/313.html) Device Classification Panels (http://www.fda.gov/cdrh/devadvice/3131.html) Medical Device 510(k) and Good Manufacturing Practice (GMP) Exemptions List (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cf m) 35 36