STERIS

Anthony Piotrkowski

Device Compliance Steward

Many people in the Regulatory world have the impression that the relationship between manufacturers and regulators borders on the adversarial, those who view themselves as David going up against the mighty Goliath when preparing a premarket submission. This is particularly true as new regulations and guidance are published that, at first glance, look like just more barriers to marketing products. My experience has been quite different. I’d like to talk about a few FDA programs that have demonstrated to me how collaborative a regulatory experience can be. And another great thing about them, is all of these programs are free, with no user fee associated.

The Q-Submission program is one of the most valuable tools available for someone preparing a premarket submission. Originating as a tool for preparing Investigational Device Exemptions in the 1990s, the program has evolved as a way for getting insight into the FDA’s current thinking on the essential elements of a submission. A well-thought-out and timed pre-submission can provide a means to obtain valuable insight into the suitability of a test plan or rationale, choice of the predicate, device classification and appropriateness of planned responses just to name a few examples. The interaction can be as basic as an email response or be more interactive through a teleconference, an in-person meeting, or even a series of meetings. It also allows the submitter a chance to meet the review staff and discuss any concerns they have regarding the safety or performance of a proposed product and better understand the best path to a positive decision.

The Experiential Learning Program provides a means for industry to provide FDA staff with information regarding their product and how they are used outside of a submission or inspection atmosphere. If you meet the requirements of the program and have knowledge of their topics of interest, you can provide information on your experiences with patient engagement, product development challenges, and/or scientific principles. Discussions of the science behind the products and demonstration of their use in a mock clinical setting can provide valuable information to the FDA and spur discussion that can help all parties better understand the challenges faced by all.

"The Experiential Learning Program provides a means for industry to provide FDA staff with information regarding their product and how they are used outside of a submission or inspection atmosphere"

The AINN teleconference (day-10 call) is a relatively recent offering. While intended to provide clarification to deficiencies noted in a submission, it also provides an opportunity to speak directly with the lead reviewer. This interaction can give valuable clarification into concerns regarding the submission or proposed product that aren’t always obvious from the paper notification and help to frame a more complete and acceptable response.

Perhaps the most collaborative program is the Medical Device Development Tool (MDDT) where scientists from industry and the FDA can work together to devise methods, materials, or measurements that can be used to assess the safety, effectiveness or performance of a medical device. The MDDT will then often become the standard by which other medical devices are assessed when preparing a premarket submission.

Industry and the FDA have the same goal, to ensure timely access to safe and effective medical devices that provide the best patient outcomes, and these programs are excellent ways that we can work together to achieve it.