Medical Device Development: Design Validation and Preclinical, Part 2 discussed starting the plan for an FDA submission early on to avoid expenses and delays. But when the time comes to finally submit your FDA submission, whether a traditional 510(k), de novo 510(k), Investigational Device Exemption (IDE), Pre-market Approval (PMA), or Humanitarian Device Exemption (HDE), there are three key areas that will accelerate the review process to a successful submission: a solid foundation, a well-developed submission package, and follow-up.
As with most project planning activities, a solid foundation is needed. Understanding FDA expectations surrounding your device is the first step to developing a firm regulatory submission strategy. A Regulatory submission strategy should include:
- A clear and concise intended/indication for use.
- Classification of the device.
- Identification of device specific standards, guidances, and regulations.
- Review of similar devices and their route to market.
- Considerations of a pre-submission meeting with FDA to review strategy or specific protocols.
The second key is to have a well-developed submission package to aid FDA’s understanding of the device. Preparation of the FDA submission should start long before the planned submission date; development of the submission shell drives the submission deliverables, and timelines. While FDA reviewers understand the concepts of the submission, they often need help understanding the specifics of your device, mechanisms of action and performance data. During the submission preparation, pay attention to:
- Device description – needs to be adequate, including the area of use, principles of operation, and basic device details.
- Indications for use – must be consistent throughout the submission.
- Standards, guidances, and regulations – should be addressed; specifically about how your submission demonstrates compliance, or why a standard is not required.
- Top level summary of pre-clinical testing – must be included within the body of the submission with full details located in the appendices.
- Refuse to Accept Checklist – must be completed specific to the submission type, and included with the submission.
- Forms – verify the correct form(s) is being used for the indication for use, Center for Devices and Radiological Health (CDRH) coversheet, and standard data forms; as applicable.
- eCopy guidance – ensure your submission is compliant.
- Final review – confirm the submission’s formatting and quality; and verify there are no extra pages, footers and headers are in place, and page numbering of entire submission is accurate. A paper copy for review is highly recommended.
The final key is follow up. After a submission has been sent to FDA, it is important to:
- Review the internal process. Consider what went well and what can be improved upon for the next submission.
- Anticipate potential questions from FDA and prepare for responses and resources.
- For a PMA, if it is anticipated, begin preparation for an advisory committee meeting.
- For an IDE submission, continue to prepare for initiation of the clinical trial, including site selection and physician training.
Please look for the next post in this series, Medical Device Development: Post-Market.
You can view the previous post in this series, Medical Device Development: Clinical Studies, Part 2, here.
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