1、Investigational Device ExemptionsUS FDA Device Clinical trial Approval,2,Overview,Investigational Device Exemptions (IDE) Regulation 21 CFR 812 Applies to all clinical investigations of devices to determine safety and effectiveness FDA oversight of conduct of study, use of device, protection of huma

2、n subjects FDA review depends upon determination of Significant Risk (SR) or Nonsignificant Risk (NSR) Device Determination made by sponsor, then IRB; FDA oversight,3,What is an IDE?,IDE permits clinical evaluation of an investigational device (21 CFR Part 812) Investigational devices have not been

3、cleared for marketing, are the object of an investigation Also includes legally marketed devices with specific modifications or new intended uses Clinical evaluation provides safety and effectiveness data to support approval and/or marketing clearance Clinical studies most often conducted in support

4、 of PMAs Only a small number of 510(k)s require clinical data,4,Purpose of IDE Regulations812.1(a),To encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use To maintain opt

5、imum freedom for scientific investigators in their pursuit of this purpose,5,Significant Risk Devices,Definition 21 CFR 812.3(m) Potential for serious risk to subjects health, safety or welfare (life threatening, impair body function/structure, necessitate medical/surgical intervention) Implant Used

6、 to support or sustain human life Substantially important in diagnosing, curing or mitigating disease Full IDE required with FDA and Institutional Review Board (IRB) approval Examples: implanted catheters, epidural/spinal needles, tracheal tubes, infusion pumps,6,Nonsignificant Risk Devices,No signi

7、ficant risk to subject Abbreviated IDE requirements No FDA approval or review of study IRB approval: study proposal, why NSR, previous studies, informed consent Monitoring, records and reports required Examples: general urological catheters, oximeters, nasal stents, anesthetic gas masks,7,Institutio

8、nal Review Boards,IRB must comply with regulations outlined in 21 CFR Parts 56 and 812 In making approval decisions, same criteria for approval of any research involving an FDA-regulated product should be used Risks and benefits of an investigational device vs. alternative devices or procedures shou

9、ld be considered Approval decisions differ from determination of significant risk, which is solely based upon the significance of harm that may result from use of the device,8,IDE - Exempted Investigations 21 CFR 812.2(c),Preamendment devices Substantially equivalent devices Diagnostic devices Nonin

10、vasive Does not require invasive sampling that presents significant risk Does not introduce energy into subject Is not used for diagnosis without confirmation Consumer preference testing,9,IDE Application21 CFR 812.20,Report of prior investigations - 21 CFR 812.27 Investigational plan - 21 CFR 812.2

11、5 Description of methods/controls/facilities for manufacturing, processing, packing and storage of device Sample PI agreement IRB chairperson contact information Labeling Informed consent forms and materials,10,FDA Actions on IDE Applications21 CFR 12.30,Sponsor may start investigation 30 days after

12、 FDA receives application (unless FDA notifies otherwise) or upon receipt of FDA order of IDE approval Approval of an IDE signifies that: IRB (and in cases of significant risk devices, FDA) has reviewed and approved the study application; Investigational devices may be lawfully shipped for the purpo

13、ses of clinical evaluation of the device, without complying with other requirements of the FFDC ; and All requirements under 21 CFR Part 812 have been met.,11,FDA Actions on IDE Applications21 CFR 812.30,Grounds for disapproval: Failure to comply with regulatory requirements Failure to respond to FD

14、A request for additional information Risk to subjects outweighs benefits; investigation scientifically unsound; there is reason to believe device is ineffective Informed consent inadequate Inadequacy of methods, facilities or controls for manufacture, processing, packing or storage of device Inadequ

15、ate monitoring and review of investigation,12,Supplemental Applications21 CFR 812.35,Prior approval required for changes in investigational plan except: Changes effected for emergency use To protect the life or physical well-being of a subject in an emergency Reported within 5 working days Changes e

16、ffected with notice to FDA within 5 days Developmental changes Changes to clinical protocol Changes submitted in the annual report Certain minor changes IRB approval of new facilities,13,Sponsor Responsibilities 21 CFR 812.42-.47,FDA or Made by sponsor to investigator or investigators institution ex

17、clusive of the costs of the clinical study or other clinical studies,16,Investigator Records 21 CFR 812.140(a),Correspondence Subject records Case histories and medical records Informed consent Relevant observations including adverse device effects Record of exposure to device Protocol and supportin

18、g documentation Other records required by FDA regulations,17,Sponsor Records 21 CFR 812.140(b),SR Devices Correspondence Records of shipment and disposition Signed investigator agreements Records for adverse device effects NSR Devices Name/intended use of device Why device is NSR Investigator and IR

19、B contact information GMP information Records for adverse device effects,18,Investigator Reports 21 CFR 812.150(a),Unanticipated adverse device effects Withdrawal of IRB approval Progress reports Deviations from investigational plan Use without informed consent Final report,19,Sponsor Reports 21 CFR 812.150(b),Unanticipated adverse device effects Withdrawal of IRB/FDA approval Current investigator list Progress reports Recall and device disposition Use without informed consent Final report Significant risk device dete