“We need a meeting with the FDA”. These words can put almost everybody in the company in panic mode. What data do we present? How long do we need to prepare the meeting package? Who will be presenting? Who will be attending the meeting? How much do we rehearse for the meeting?
The days of only face to face meetings with Food and Drug. Administration (FDA) staff– AKA “the Agency”, requiring lengthy travel are long gone. Today, thanks to technology, there are other options that can be used. Teleconferences and technology such as GoToMeeting for sharing presentations are often used instead and are very convenient when working with a global team. Even better, if the Agency’s written feedback provided before the meeting is satisfactory and sufficient, the meeting can be cancelled.
Often small companies don’t think they should meet with the FDA, but the pre-submission program is especially beneficial to them if they lack a big medical device company’s resources and experience interacting with the FDA. They may not be familiar with FDA submission requirements based on past submission experience.
The Center for Device Evaluation and Radiological Health (CDRH) provides various opportunities for applicants to receive feedback: pre-submission meetings, informational meetings, agreement and determination meetings, submission issue meetings and day 100 meetings. They each provide different types of feedback depending on your submission type and device class but they all provide similar benefits to the applicants/sponsors, especially when you are the new kid on the block. Here are 5 reasons why small medical device companies should use the FDA Pre-Submission program:
- Establish a relationship with the FDA and the review team.
- Help the FDA to understand and know better your device, which subsequently helps in their review process.
- Identify any deficiencies before your submission goes in so they can be addressed in a timely manner.
- Seek agreement on the protocol from the FDA to avoid study repetition if your device requires a lengthy pre-clinical testing.
- Ensure the trial design is acceptable to the FDA and adequate for device approval If your device requires a clinical trial.
Pre-Submission meetings (or Pre-Subs as the FDA calls them) are useful for asking device-specific questions during submission preparation. For example when a new device involves novel technology, or you are proposing a new indication for an existing device, or the new device does not clearly fall within the established regulatory Pathway, you can use the meeting to seek input or feedback on a specific issue in your submission.
Informational meetings are intended to share information without the expectation of feedback and may be appropriate to provide an overview of ongoing device development when multiple submissions are planned within the next 6-12 months or to familiarize the review team with a new device.
The FD&C Act, as amended by FDAMA, provides for two early collaboration meetings; Determination Meetings and Agreement Meetings. These meetings are intended to facilitate interaction between the FDA and applicants and to provide clear direction for the testing and development of devices requiring clinical investigations to support marketing.
A Submission Issue Meeting is suitable to discuss deficiencies identified during premarket review of a 510(k), de novo, IDE, HDE, PMA, IND or BLA application or CLIA Waiver by Application, including associated amendments or supplements. Such a meeting is intended to provide clarification of the FDA’s questions and/or to discuss an approach for responding to complex issues.
A Day 100 Meeting is intended to discuss the review status of a PMA application.
Detailed information on how to request a meeting, what information to provide to the Agency and what feedback to expect is provided in the FDA guidance “Request for feedback on Medical device submissions: The Pre-Submission program and Meetings with Food and Drug administration staff” published on February 18, 2014.
The meetings with industry and other sponsors described above allow for an open discussion and exchange of technical, scientific, and regulatory information. These meetings can help build a common understanding of the FDA’s views on clinical, nonclinical, or analytical studies related to an IDE or marketing application. Talking to the FDA early can prevent delays, reduce costs and help get your device to market sooner.
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