FDA Medical Device Rules

1. FDA Medical Device Rules Robert F. Munzner, Ph.D. www.DoctorDevice.com

2. “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

3. Legal Interpretation:

4. What is a Medical Device ? Defined by Law

5. Definition of Device • -- Physical Device (Hardware) • -- Intended Use (Medical) • -- but not a drug

6. Hardware • instrument, • apparatus, • implement, • machine, • contrivance, • and etc., • or any part, accessory ...

7. Intended : • for diagnosis of disease • for treatment of disease • to affect structure/function of the body

8. FDA Mandate: Assure that Medical Devices are Safe and Effective

9. What is “Safe” • Risk • Benefit

10. Safe: Benefits outweigh Risks

11. Benefit: -- implies effectiveness can be measured

12. Effectiveness: -- for what need or condition (Indications) -- for whom & what circumstances (Intended Use)

13. Device Classes Class I -- General Controls (apply to all) Class II -- Special Controls (aka Standards) Class III -- Premarket Approval

14. To Sell:

15. NEW DEVICES

16. “New” but Similar

17. “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

18. 510(k) • Notice of intent to market • Description of the Device • Comparison with a “Predicate” Device

19. 510(k) Contents • there is no “form” per se • generally described in 21 CFR 807.87 • FDA provides specific “guidance” • Checklist is available

20. 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

21. FDA Guidance Documents • Are not legal requirements • Intended to help 510(k) prep • Not available for every device • www.cdrh.fda.gov/guidance

22. Check List • Used for “Refuse to File” • Includes some necessary administrivia • Hard to find from web site (see hard copy)

23. 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

24. Device Classification • Same as the “equivalent” predicate • If not SE to predicate, de novo classification is possible • If NSE and Class III, PMA required

25. 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

26. 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

27. 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

28. Class III Devices • Frequent, Thorough Site Inspections • Class I and Class II Rules Apply Also • May be required to file PMA • Reclassification possible