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Closing Remarks

Closing Remarks. Tina Morrison, PhD Mechanical Engineer / Scientific Reviewer Division of Cardiovascular Devices Food and Drug Administration. Review of an IDE . Today we outlined the required elements of an IDE application

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Closing Remarks

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  1. Closing Remarks Tina Morrison, PhD Mechanical Engineer / Scientific Reviewer Division of Cardiovascular Devices Food and Drug Administration

  2. Review of an IDE • Today we outlined the required elements of an IDE application • And we shared our opinions on how to make the IDE a successful application • A team of experts review the contents of the application. The team may consist of • Medical Officer • Statistician • Engineers (biomedical, chemical, mechanical, …) • Microbiologists • Chemist • Others

  3. Review of an IDE • The team is organized by the lead scientific reviewer • which could be one of the experts previously mentioned • At the end of the 30-days, the lead reviewer will make a recommendation for the IDE, based on their knowledge and the input from the consulting reviewers. • Options: Approved, Approved with Conditions, Disapproved

  4. Approval • Granted when FDA believes that an adequate demonstration of device safety and study validity has been provided to allow use in human subjects, i.e., • Adequate information has been submitted to address all non-clinical safety concerns about use of the device in the proposed patient population • The study design is capable of generating valid clinical evidence necessary to support marketing approval • Granted when minor concerns are still present that are not expected to unreasonably impact patient safety or study validity • A study can be initiated after an IDE has been approved or conditionally approved and IRB approval has been obtained. Approval with Conditions

  5. Disapproval • If FDA believes that adequate safety/validity has not been demonstrated, we will disapprove the IDE until the significant issues have been addressed satisfactorily • In the regulation, 21 CFR 812.30(b): 1) there has been a failure to comply with any requirements of the laws and regulations; 2) the application contains false information or omits material information required by the regulation; 3) there is reason to believe that the risks to the subjects may outweigh the potential benefits to the subjects and the importance of the knowledge to be gained; 4) the informed consent is inadequate, the investigation is scientifically unsound, or there is reason to believe that the device is ineffective; or 5) it is otherwise unreasonable to begin the investigation owing to the way in which the device is to be used or the inadequacy of the report of prior investigations.

  6. Disapproval • Examples: • Animal study data demonstrated safety concerns • Inadequate engineering evaluation of device or delivery system • Lack of sufficient risk assessment • Proposed collection of inappropriate clinical data

  7. Total Product Life Cycle of a medical device Nonclinical Testing Prototype design or upgrade FDA filing & Launch preparation Possible changes Basic research pre-market Clinical Evaluation Market approval/ clearance Market application IDE

  8. Most Valuable Resource – The Reviewer • One of FDA’s outreach efforts includes “pre-submission” meetings: • informal exchange of information between reviewers and investigators (device manufacturers or clinicians) Nonclinical Prototype design or upgrade Possible changes FDA filing & Launch preparation Basic research pre-market Clinical Market approval/ clearance Market application Meetings with FDA =

  9. Closing Remarks • The challenge with communicating the FDA’s requirements for medical devices is that each device is very different, with different intended uses and patient populations • Take advantage of pre-submission meetings • We hope the information we presented today will help you complete your device puzzle.

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