Patient Perspectives Sought on Device Enforcement Actions
CDRH says that it will take into consideration an assessment of patients’ tolerance for risk when deciding whether to take a regulatory action that could remove a medically necessary medical device from the market. This was explained during a 7/11 webinar (see transcript) on a draft guidance on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions, which clarifies for industry and agency staff the benefit and risk factors FDA may consider in prioritizing resources for compliance and enforcement efforts.
The agency says the document is not intended to limit agency action, but rather describes the general framework for medical device decision-making. “Product availability and other medical device compliance and enforcement decisions are generally fact-specific,” the guidance says. “However, FDA believes that explaining how we consider the factors listed in this draft guidance document will improve the consistency and transparency of these kinds of decisions. A common understanding of how FDA considers benefit and risk may better align industry’s and FDA’s focus on actions that maximize benefit to patients, improve medical device quality, and reduce risk to patients.”
In certain situations involving patient harm risks, “FDA and industry individually or collaboratively can help maximize benefit and reduce risk to patients by assessing the situation, considering the patient’s perspective, evaluating any regulatory noncompliance or device nonconformity in light of a benefit risk profile for the device, factoring in alternatives where available, considering the benefit risk trade-off for patients of each decision option and then determining the most appropriate next step,” CDRH Office of Compliance director Robin Newman said during the webinar.
During the question and answer session, agency officials were asked how sponsors or FDA should combine different aspects of either risk or benefit to get an overall picture and how should one go about comparing benefits to risk? “One of the things that we’re encouraging, and you’ll see this in the guidance document, is to really utilize the clinical expertise of the physicians and clinicians that we have here within FDA as well as frankly the clinicians and physicians that we work with in industries and that companies have within their domain,” Newman said. “This is a critical piece of this assessment.”
Asked to clarify which part of the process a risk benefit analysis would be appropriate on the manufacturer’s side, Newman said it should be incorporated at the time of the health hazard evaluation. “Look at the things you’re doing to your risk assessment and mitigation activities and then making this part of that whole product lifecycle. Remembering also to go back and revisit those risk assessments as you have more experience with the product and you have more information coming in with regard to everything from user interface, to patient toxicities, to the overall experience that patients have with these products. And this does require, honestly, a sort of proactive seeking of information from the customer that does not always happen. And I would strongly encourage that as well, because that’s where the most information lives and breathes.”