Significant risk device (SR device)
Significant risk device is an investigational device that:
- is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
- is for use in supporting or sustaining human life and represents a potential for serious risk to the health, safety, or welfare of a subject;
- 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
- otherwise presents a potential for serious risk to a subject.
Examples include sutures, cardiac pacemakers, hydrocephalus shunts, and orthopedic implants.
Studies of devices that pose a significant risk require both FDA and an Institutional Review Board (IRB) approval prior to initiation of a clinical study. FDA approval is obtained by submitting an IDE application to FDA (§812.20).
In order to conduct a significant risk device study, a sponsor must:
- submit a complete IDE application (§812.20) to FDA for review and obtain FDA approval of the IDE;
- submit the investigational plan and report of prior investigations (§812.25 and §812.27) to the IRB at each institution where the investigation is to be conducted for review and approval; and
- select qualified investigators, provide them with all necessary information on the investigational plan and report of prior investigations, and obtain signed investigator agreements from them.
Featured Products
![CAPA Solution for Quality Management Systems RFP Template](https://static.complianceonline.com/images/newUI/images/docu_img.jpg)
ISO 13485 Internal Auditor Checklist
Price: $95.00
Price: $95.00
Best Practices for Maintaining an IND and IDE Application with FDA
IND and IDE annual reports - Amending clinical protocols and informed consent – Format, Content, Editing, Submission of Documents
IND and IDE annual reports - Amending clinical protocols and informed consent – Format, Content, Editing, Submission of Documents
IDE (Investigational Device Exemption) for PMA and 510(k) for CDRH and CBER
Meetings with FDA - Sample Size Considerations - Inclusion/Exclusion Criteria - End Points - Case Report Forms - Administrative Plan
Meetings with FDA - Sample Size Considerations - Inclusion/Exclusion Criteria - End Points - Case Report Forms - Administrative Plan
The IDE (Investigational Device Exemption) - It's Purpose and Preparation
The purpose of the IDE – FDA Expectations – preparation – recommended subject headings – content submission - follow up Usage in the clinical trial
The purpose of the IDE – FDA Expectations – preparation – recommended subject headings – content submission - follow up Usage in the clinical trial
Planning for a Successful Pre-IDE Meeting with FDA
Pre-IDE Meeting – Process- Submission preparation - presentation
Pre-IDE Meeting – Process- Submission preparation - presentation