Medical Device Regulations

Transcription

1 Research Compliance Office Medical Device Regulations Jennifer S. Brown, RN IRB Education August 2008

2 Today s Topics AAHRPP FDA regulations Research categories Significant risk, NSR, IDE exempt IRB responsibilities January 2008 Research Compliance Office 2

3 AAHRPP Elements Standard I-5: The Organization has and follows written policies and procedures that use of any investigational or unlicensed test article complies with all federal, state, or local regulations. Element I.5.A: The Organization secures assurances from the sponsor that the manufacture and formulation of investigational or unlicensed test articles conform to federal regulations. Research Compliance Office 3

4 Device Research Regulations IDE Regulations 21 CFR 812 Investigational Device Exemption Allows shipment of devices before they are approved for research purposes Exempt from law prohibiting interstate transfer of unapproved devices or unlicensed biologics Device clinical trials still require IRB review Regulations cover sponsors, investigators, and IRBs Distinct from device classification or marketing regulations Research Compliance Office 4

5 Clinical Investigation Types Significant risk studies Require approved IDE application from FDA All parts of 21 CFR 812 apply Nonsignificant risk studies Not a SR study (4 lavender laminate criteria) Do not place participants at significant risk Abbreviated 21 CFR 812 requirements apply IDE exempt studies Studies not regulated according to 21 CFR 812 Research Compliance Office 5

6 Significant Risk Definition Significant risk device means an investigational device that: (1) Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; (2) Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject; (3) Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or (4) Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. 21 CFR 812.3(m) Research Compliance Office 6

7 IDE Exempt Studies 21 CFR 812 does not apply to investigations of Legally marketed devices used or investigated in accordance with the indications in the labeling (Examples: incidental use, post-marketing studies) In vitro diagnostic devices (unapproved) if certain criteria are met (non-invasive, does not introduce energy, labeled correctly, not used to diagnose) Studies of Devices undergoing consumer preference testing, or Device modifications, or Two or more devices commercially available in combination,... and if the testing is not for the purpose of determining safety and effectiveness and does not put subjects at risk These studies may be appropriate for Expedited Review Research Compliance Office 7

8 Points to Consider How is device used in the study? Incidental use, post-marketing? (IDE exempt) What are approved indications? Intended use (to cut) Indications for use (to make incisions on the cornea) more specialized What are proposed indications (study endpoint)? Who is sponsor? Will study results be submitted to the FDA What does sponsor expect? (consent form clues) Is study investigator initiated? Sponsor-investigator regulations apply for both SR & NSR Research Compliance Office 8

9 eprotocol Questions Research Compliance Office 9

10 Summary Three types of device studies SR or NSR or IDE exempt Ask questions about device use in study Understand indications for use Evaluate risk of device use Unapproved device? SR or NSR? Commercial device for new indications? SR or NSR? IRB must Receive copy of FDA s documentation of IDE (SR studies) Make NSR finding (NSR studies) Confirm IDE exemption status Research Compliance Office 10

11 References and Resources FDA Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: Significant Risk and Nonsignificant Risk Medical Device Studies Frequently Asked Questions About Medical Devices FDA Device Advice Stanford HRPP Chapter 5 Investigational or Unlicensed Test Articles Research with Drugs, Devices or Biologics Research Compliance Office 11