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Overview of FDA Device Regulations

Overview of FDA Device Regulations. Bob Assenzo Critical Path Institute bassenzo@c-path.org. Overview of FDA Device Regulations - Outline. Introduction Establishment Registration – 21 CFR 807 Medical Device Listing – 21 CFR 805 Premarket Notification 510(k) – 21 CFR 807 Subpart E

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Overview of FDA Device Regulations

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  1. Overview of FDA Device Regulations Bob Assenzo Critical Path Institute bassenzo@c-path.org

  2. Overview of FDA Device Regulations - Outline • Introduction • Establishment Registration – 21 CFR 807 • Medical Device Listing – 21 CFR 805 • Premarket Notification 510(k) – 21 CFR 807 Subpart E • Premarket Approval (PMA) – 21 CFR 814

  3. Overview of FDA Device Regulations – Outline (cont.) • Investigational Device Exemption (IDE) – 21 CFR 812 • Quality System Regulation (QS)/Good Manufacturing Practices (GMP) – 21 CFR 820 • Labeling – 21 CFR 801 • Medical Device Reporting – 21 CFR 803

  4. Introduction to Device Regulations • FDA’s Center for Devices & Radiological Health (CDRH) is responsible for regulating firms that manufacture, repackage, relabel, and/or import medical devices sold in the US. • Additionally, CDRH regulates radiation-emitting electronic products (medical & non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens & color TVs

  5. Introduction to Device RegulationsClassifications • Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to III. • The device classification defines the regulatory requirements for a general device type.

  6. Introduction to Device RegulationsClassifications (cont.) • Most Class I devices are exempt from Premarket Notification 510(k) • Most Class II devices require Premarket Notification 510(k) • Most Class III devices require Premarket Approval • For classification determination see: www.fda.gov/cdrh/devadvice/313.html

  7. Device Classification Panels • Most medical devices can be found in 21 CFR 862 – 893 • FDA has classified and described over 1,700 distinct types and organized them into 16 medical specialty panels, e.g. 870 is cardiovascular; 886 is ophthalmic • The CFR gives a general description, use, class, and info about marketing requirements • www.fda.gov/cdrh/devadvice/3131.html

  8. Introduction to Device RegulationsBasic Requirements • Establishment registration • Medical Device Listing • Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA) • Investigational Device Exemption (IDE) for clinical studies • Quality System (QS) regulation • Labeling requirements • Medical Device Reporting (MDR)

  9. Establishment Registration – 21 CFR Part 807 • Manufacturers, domestic & foreign, and initial distributors (importers) of medical devices must register their establishments with the FDA. • All establishment registrations must be submitted electronically, unless FDA grants a waiver • All registration information must be verified annually (Oct 1-Dec 31) • Foreign manufacturers also must designate a US agent • Most establishments are required to pay an establishment registration fee

  10. Medical Device Listing – 21 CFR Part 807 • Manufacturers must list their devices with the FDA. Establishments required to list: • Manufacturers • Contract manufacturers that commercially distribute the device • Repackagers and relabelers • Specification developers • Reprocessors single-use devices • Remanufacturer • Manufacturers of accessories and components sold directly to the end user • US manufacturers of “export only” devices

  11. Premarket Notification 510(k) –21 CFR Part 807 Subpart E • If device requires the submission of a Premarket Notification 510(k), it cannot be commercially distributed until an authorizing letter of substantial equivalence from FDA is received • A 510(k) must demonstrate that the device is substantially equivalent to one legally in commercial distribution in the US: (1) before May 28, 1976, or (2) to a device that has been determined by FDA to be substantially equivalent • www.fda.gov/cdrh/devadvice/314.html

  12. Premarket Notification 510(k) –21 CFR Part 807 Subpart E (cont) • The Medical Device User Fee and Modernization Act of 2002 authorizes FDA to charge a fee for medical device Premarket Notification 510(k) reviews. • Most Class I and some Class II devices are exempt from the Premarket Notification 510(k) submission. See • www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm

  13. Premarket Notification 510(k) –21 CFR Part 807 Subpart E (cont) • Review by Accredited Persons: • FDA has accredited 12 organizations to conduct a primary review of 670 types of devices. • FDA must issue a final determination within 30 days after receiving a recommendation from an Accredited Person • Accredited Person is exempt from any FDA fee; the third party may charge a fee for its review

  14. Premarket Approval (PMA) –21 CFR Part 814 • Products requiring PMAs are Class III devices that are high risk devices that pose a significant risk of illness or injury, or devices found not substantially equivalent to Class I & II predicate through the 510(k) process (Fee required) • The PMA process is more involved and includes the submission of clinical data to support claims made for the device • See www.fda.gov/cdrh/devadvice/pma/

  15. Investigational Device Exemption (IDE) – 21 CFR Part 812 • An IDE allows the investigational device to be used in a clinical study to collect safety & effectiveness data required to support a PMA application or a Premarket Notification 510(k) submission to FDA. • Clinical studies of devices with significant risk must be approved by FDA and an IRB before study can begin • Studies of devices of nonsignificant risk must be approved by the IRB before study can begin • See www.fda.gov/cdrh/devadvice/ide/index.shtml

  16. Quality System Regulation (QS)/Good Manufacturing Practices (GMP) – 21 CFR Part 820 • The quality system regulation includes requirements related to the methods used in and the facilities and controls used for: designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices • Manufacturing facilities undergo FDA inspections to assure compliance with the QS requirements • See www.fda.gov/cdrh/devadvice/32.html

  17. Labeling – 21 CFR Part 801 • Labeling includes labels on the device as well as descriptive and informational literature that accompanies the device • www.fda.gov/cdrh/devadvice/33.html

  18. Medical Device Reporting –21 CFR Part 803 • Incidents in which a device may have caused or contributed to a death or serious injury must be reported to the FDA • Certain malfunctions also must be reported • The MDR regulation is a mechanism for identifying and monitoring significant Aes • www.fda.gov/cdrh/devadvice/351.html

  19. Guidance Documents • Good Guidance Practice (GGP) relate to: • The processing, content, and evaluation of regulatory submissions • The design, production, manufacturing, and testing of regulated products • The inspection and enforcement procedures • www.fda.gov/cdrh/guidance-about.html

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