We can all agree that FDA has the right to set expectations for efficient and appropriate interaction with their review teams. However, FDA’s latest updates to the Q-sub guidance create more confusion than clarity and reveal frustrations at FDA with how industry is using the pre-submission program. As medical product development continues to become more complex along with the regulatory pathways we use to get them to market, FDA needs to find a balance between setting boundaries and putting up barriers to communication.
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On February 2, 2024, we finally got our long awaited Final Rule establishing the new Quality Management System Regulations (QMSR) from the FDA. The new QMSR is essentially the full implementation of ISO 13485 by incorporating the entirety of this standard by reference. With global regulatory frameworks becoming more difficult to manage in terms of compliance, harmonizing with the entirety of the ISO standard with FDA regualtions should have a net positive effect on industry.
Read MoreFDA has raised the bar on real-world evidence (RWE) studies with its new draft guidance. FDA’s expectations that RWE studies be good quality, rigorous, and conducted under a protocol and with IRB approval are not new. But the depth of data assessment, documentation, and requirements for submission outlined in this guidance have been augmented beyond what may be reasonable. A greater desire by regulators for clinical data to support medical device safety and effectiveness is here to stay, not just at FDA, but globally. While the motivations are genuinely for the benefit of public health, the reality is that clinical and observational research is expensive, complicated, time consuming, and burdensome. These costs will ultimately be passed down to payers and patients. I am not sure the incremental confidence FDA has in its regulatory decisions is worth the cost.
Read MoreA recent Northeastern University panel discussion about about the history and future of governance in artificial intelligence got me thinking about harmonization of medical device regulatory policy and wondering why it is so hard to do. As medical device technology is advancing at breakneck speed to bring AI-driven medical devices to patients and practitioners, we are seeing a rapid increase in policy implementation and legislation all intended to govern the use of AI in medical devices - but without much harmonization. Similar lack of harmonization in device classification, quality systems, and RWD/RWE governance have created barriers and costs to industry. With IMDRF being only a voluntary-based collaborative organization, what can be done to facilitate global harmonization of medical device regulation?
Read MoreRequirements for clinical evidence of medical device safety and performance are increasing globally. Not only in Europe, but in Australia and the United States. For devices that have already been on the market in the United States, you may have an option you hadn’t thought of: a retrospective observational research study. This option is particularly useful for implants, but can be used for any medical device used by or prescribed by a clinician in the United States. Simply put, you can tap into existing medical records to gather sufficient clinical evidence of the safety and efficacy of your device. You just have to make sure you do it the right way.
Read MoreOn September 7, 2023, FDA released a new guidance document as part of the 510(k) modernization plan that sets out potential requirements for clinical data in pre-market submissions for Class II medical devices. This guidance should give pause to industry as the vague language appears to give FDA broad authority to request pre-market clinical data for Class II medical devices. The requirements appear to mimic what is happening in the EU under MDR where sufficient clinical data is necessary for a MDR CE mark of these same devices. Did the 510(k) program just get an EU MDR upgrade? If so, these new requirements will hamper innovation and delay patient access to new devices.
Read MoreCommenters on FDA’s recently opened docket for proposed changes to the PPI Guidance made their recommendations clear: we need more specificity in FDA’s expectations for use of PPI data in regulatory decision-making. Specifically, there is a strong desire for FDA use existing best practice recommendations; the need to increase the expectation and accountability of those conducting PPI studies to engage patients in the study design process; more transparency around how FDA will use PPI data in its decision-making; a desire to see the guidance expanded to therapeutics beyond medical devices; consistency in attribute definition and utilization; and greater clarity around FDA’s expectations for study methodology. The hope is that FDA takes these thoughtful and substantive comments into account when updating the PPI guidance.
Read MoreFDA recently requested public comment on updates to the PPI Guidance. The most common theme in the comments submitted suggested that all of us want to know what FDA really thinks about PPI studies and how they can support medical device regulatory decisions. If FDA can update the guidance with more transparency, the medical device industry will benefit and so will patients.
Read MoreDozens of papers, workshops, and white papers have been published in the last few years addressing the myriad of challenges and opportunities associated with the use of real-world evidence (RWE) as evidence of medical product safety and effectiveness. This quarter, I will be teaching the first course addressing real-world evidence in biomedical research for Northeastern University's online graduate regulatory affairs program. The wealth of information available on all facets of real-world evidence use is nearly overwhelming. Yet, it remains unclear whether we can effectively harness the volumes of available data in an ethical and effective manner.
Read MoreA recent commentary by Peter Pitts of the CIOMS patient engagement working group warrants further discussion. He makes excellent points about the need for meaningful patient data, but highlights the institutional roadblocks and questions that linger about the benefit of patient engagement in medical product development. In reality, the roadblocks are real, and it will take sophisticated change management to overcome existing barriers to make patient engagement a ubiquitous reality in the medical products industry.
Read MoreFDA announced a list of preference-sensitive areas based on input from CDRH review teams. This is a tremendous opportunity for industry to engage with FDA and determine how patient preference data can support a sponsor’s medical device regulatory and clinical strategy.
Read MoreModern patient engagement regulatory policy has its origins in the HIV/AIDS advocacy movement. Legislation in 2012 provided FDA with the power to initiate several new patient-focused initiatives. There has never been a better time for the patient voice to be heard by regulatory decision-makers.
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