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1 Overview of FDA Device Regulations Bob Assenzo Critical Path Institute

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1 1 Overview of FDA Device Regulations Bob Assenzo Critical Path Institute

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

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

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

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

6 6 Introduction to Device Regulations Classifications (cont.) Most Class I devices are exempt from Premarket Notification 510(k) Most Class I devices are exempt from Premarket Notification 510(k) Most Class II devices require Premarket Notification 510(k) Most Class II devices require Premarket Notification 510(k) Most Class III devices require Premarket Approval Most Class III devices require Premarket Approval For classification determination see: For classification determination see:

7 7 Device Classification Panels Most medical devices can be found in 21 CFR 862 – 893 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 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 The CFR gives a general description, use, class, and info about marketing requirements

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

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

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

11 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 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 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

12 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. 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 Most Class I and some Class II devices are exempt from the Premarket Notification 510(k) submission. See

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

14 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) 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 The PMA process is more involved and includes the submission of clinical data to support claims made for the device See See

15 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. 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 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 Studies of devices of nonsignificant risk must be approved by the IRB before study can begin See See

16 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 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 Manufacturing facilities undergo FDA inspections to assure compliance with the QS requirements See See

17 17 Labeling – 21 CFR Part 801 Labeling includes labels on the device as well as descriptive and informational literature that accompanies the device Labeling includes labels on the device as well as descriptive and informational literature that accompanies the device

18 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 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 Certain malfunctions also must be reported The MDR regulation is a mechanism for identifying and monitoring significant Aes The MDR regulation is a mechanism for identifying and monitoring significant Aes

19 19 Guidance Documents Good Guidance Practice (GGP) relate to: Good Guidance Practice (GGP) relate to: The processing, content, and evaluation of regulatory submissions The processing, content, and evaluation of regulatory submissions The design, production, manufacturing, and testing of regulated products The design, production, manufacturing, and testing of regulated products The inspection and enforcement procedures The inspection and enforcement procedures


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