Recent Pre-Market Activities at FDA

By Sangita Viswanathan
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FDA recently released changes and updated guidance documents to its pre-market assessment of medical devices. Susan Alpert, M.D., Ph.D., Principal, SFA Consulting LLC, provides the perspective of the industry and offers suggestions on what can be done to improve pre-market risk management.

New developments with both the pre-market assessment and changes to 510(k) are increasingly taking into account patients’ perceptions and experience, and it all has to do with increasing benefit-risk assessment. What do patients really want, appreciate, care about and are willing to deal with when it comes to getting the benefit of better quality of life and less pain, versus the risk of dealing with a device, are factors being considered, describes Susan Alpert, M.D., Ph.D., Principal of SFA Consulting, LLC.

Alpert told attendees at Medical Device Summits “Risk Management throughout the Product Life Cycle” conference last week, that both guidance documents have lots of examples, and advised audience members to read them even if they had nothing to do with their products.

“There is a lot of guidance coming out, but someone on your organization needs to be on each of them, as they will impact both your submission and how you will develop your technologies. You need to understand both documents to understand FDA’s thought process, and this will help you develop more data around your devices, and prepare for a better submission and interaction with FDA,” explained Alpert.

According to her, with 510(k) guidance, the new guidance is not too different from the earlier version. Submissions still need substantial equivalence, a predicate, intended use etc. “You can have different technology as long as you don’t have to answer different questions on safety and efficacy. But FDA doesn’t specify when it is considered to be a new question on safety and efficacy,” Alpert added.

Another advice that Alpert had for executives at the conference was that FDA only knows what you tell them about your product, especially if it is a new technology and not already in the market. So the response you get is based on what you have already told them about your product, testing, risk assessment etc., she explained encouraging greater dialog and transparency during pre-market submissions. She added that guidance document states that you cannot use random examples to substantiate your device, but FDA can use it to ask questions, so while this cannot be a basis of your benefit-risk assessment, it will be sure to influence the questioning.

“So know the actual number of hazards associated with your product – serious risks, non-serious risks, in failure mode, and both number and percentage matters. How many actual events are you reporting? What do you know about number of events that have happened in related products? Are you using labeling the right way to mitigate risks?” Alpert described.

Addressing the topic of PMAs and de novos, Alpert suggested keeping the following in mind:

  1. Probability of risk, and populations of patients you are studying: For product development and IDEs, learn about who is it going to be used on, is it a segmented population?
  2. Benefit-risk issues: Can this change even for products that are similar? What about the mitigation timeline?
  3. Uncertainty: What do you believe that uncertainty is, where is the softness in the data and what does it mean to the patients who are going to be treated or diagnosed? And what are you doing to mitigate that uncertainty?
  4. Mitigation: What’s pre-clinical mitigation? Some clinical issues, you will not know about until you do your clinical trial. Some you may have anticipated, but the rates could be different. Patients experience could be different. You have to do specific mitigation based on that.

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