1 / 15

Overview of Device Regulations

Overview of Device Regulations. David Arvelo Small Business Representative. Total Product Life Cycle. Device Classification System. Increases with level of risk Class I Class II Class III Determines level of regulation applied to the device. Class I Devices. 46% of all devices

steven-meyers
Download Presentation

Overview of Device Regulations

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Overview of Device Regulations David Arvelo Small Business Representative

  2. Total Product Life Cycle

  3. Device Classification System • Increases with level of risk • Class I • Class II • Class III • Determines level of regulation applied to the device

  4. Class I Devices • 46% of all devices • Low-risk devices • Surgical instruments, wound dressings, toothbrush • General Controls • Most are exempt from Premarket Notification, 510(k)

  5. General Controls • Establishment Registration • Medical Device Listing • Good Manufacturing Practice (Quality System Regulation) • Device labeling • Premarket proof of safety and effectiveness, i.e., 510(k)

  6. Class II Devices • 47% of all devices • Moderate-risk devices • E.g., blood pressure cuffs, vascular clamps, sutures, aneurysm clips, oximeters, urology catheters, cautery devices • General and Special Controls • Most not exempt from Premarket Notification, 510(k)

  7. Special Controls • Performance standards • Guidance documents • Clinical data, special labeling, warnings, precautions, contraindications • Postmarket surveillance • Patient registries • Tracking, Adverse Events

  8. Class III Devices • <10% of all devices • Moderate and high risk devices • Pacemakers, breast implants, vascular grafts, lithotripters, lasers • General Controls, Special Controls, and Premarket Approval (PMA) • Clinical data needed (IDE)

  9. Device Categories • 1746 Categories • 786 Class I • 729 exempt from 510(k) • 860 Class II • 68 exempt from 510(k) • 100 Class III

  10. Quality System Guidance • Medical Device Quality Systems Manual: A Small Entity Compliance Guide • FDA 97-4179 • Available free online at www.fda.gov

  11. www.fmdic.org

  12. DSMICA • Division of Small Manufacturers, International, and Consumer Assistance • Device Advice • CDRH Learn • CDRH Databases • Toll-free in the USA 1-800-638-2041 • Email Industry.Devices@fda.hhs.gov

  13. Office of Combination Products • FDA assistance and guidance for manufacturers of drug/device/biologic combination medical products • Phone 301-796-8930 • Fax 301-847-8619 • Email combination@fda.gov • http://www.fda.gov/CombinationProducts/

  14. My Contact Information • David Arvelo, SBR • FDA/ORA/SWRO (HFR-SW2)4040 N. Central ExpresswaySuite 900Dallas, TX 75204 • Telephone 214-253-4952 • Fax 214-253-4970 • Email david.arvelo@fda.hhs.gov

More Related