The FDA has developed an Investigational Device Exemption (IDE) decision policy on how to interpret the new changes to FDASIA 601 in terms of implementation of the law. On July 2, 2012, the FDA published the IDE decision transcript and posted the relevant presentation. StarFish Medical recommends that all sponsors and potential sponsors read the transcript and submit comments before the September 12, 2013, due date.
The FDA published its draft guidance in Nov 2011 – and comments are being accepted until September 12, 2013, after which the final document will be published. The guidance document contains more details of the current FDA thinking on the IDE.
Most important to StarFish Medical clients and partners, unlike an existing pre-submission (pre-IDE process), a pre-decisional IDE would need to be a complete submission similar to what is expected for a formal IDE submission. A device evaluation strategy to address the risks of the device as well as the mitigations that are in place in terms of the testing and evaluations of the device in addition to certain elements of the protocol should be included. Unlike a pre-submission, a pre-decisional IDE would receive a comprehensive review by the FDA resulting in a complete list of the FDA’s deficiencies communicated to the sponsor.
The FDASIA is focused on moving FDA’s approval and disapproval decisions away from study design issues and focusing them more on device safety and subject safety considerations. The FDA wants to work with study sponsors and develop studies that will support future marketing applications with the ultimate goal of reducing the time and costs associated with the conduct of clinical trials and improving US patient access to new devices.
As a result of this decision, the FDA modified the IDE decision letter templates to specifically add ‘Study Design Considerations’; either the FDA agrees with the study design or points out changes that they believe are needed in order for the study design to support the goals of the study. In addition, the FDA proposed a new voluntary, comprehensive, interactive review process to assist in the development of appropriately designed pivotal studies (Pre-Decisional IDE-voluntary approach):
Some of the highlights of the changes to the IDE process include:
- The FDA shall not disapprove an IDE on the basis of the FDA’s belief that the study is inadequate to support a future PMA or 510K or HDE.
- Approval decisions:
- FDA does not have any remaining questions that must be addressed prior to enrollment of the approved number of subjects.
- The study is approved for a specified number of enrolled subjects and investigational centers and the study may be initiated upon IRB approval.
- Approval with Conditions
- Despite some outstanding issues the information provided to the FDA is sufficient to justify human clinical evaluation of the device and the proposed study design is acceptable with regard to the protection of study subjects.
- Resolution of the outstanding issues is not required prior to initiation of enrollment in the study with the exception of certain issues related to the informed consent document, which must be correct prior to enrollment.
- The sponsor may begin the study upon receipt of IRB approval on the condition that within 45 days from the date of FDA’s decision letter the sponsor submits information addressing the issues identified in FDA’s letter.
- Staged or Staged Approval with Conditions
- Granted while certain outstanding questions are answered concurrently with enrollment of a limited number of subjects.
- If the benefit-risk profile is sufficiently favorable to justify enrollment of a portion of the study subjects, this approach allows initiation of a study while providing additional mitigation of risk by limiting exposure of the device to a smaller subject population.
- The sponsor will be permitted to expand enrollment once an IDE supplement containing the necessary additional information is submitted to the FDA and found to be acceptable.
- The sponsor may not initiate the clinical investigation until the amendment to the IDE addressing the deficiencies results in a new letter from the FDA granting approval or approval with conditions.
- Criteria for disapproval:
- A failure to comply with any requirement of 21 CFR Part 812 (IDE) or Section 520G (IRB).
- The application or report contains an untrue statement or omits information required by 21 CFR Part 812.
- The sponsor fails to respond to a request for additional information within the time prescribed by FDA.
- Risks to the subjects are not outweighed by the anticipated benefits to the subjects and the importance of the knowledge to be gained.
- The informed consent requires changes to adequately inform subjects
- The investigation as proposed is scientifically unsound
- The device as used is ineffective
Contact your StarFish Medical program manager or Vesna Janic, Director QA/RA at StarFish Medical, to discuss the potential impact on your medical device products.