MedPath

FDA Device Panel Members Suggest Improvements to Premarket Approval Process

• A survey of FDA device panel members reveals opportunities to enhance the premarket approval (PMA) process for medical devices, particularly regarding trial design and device labeling. • Panelists suggest preemptive consultation on trial design and device labels, with 89% and 84% support, respectively, to improve the quality and relevance of clinical data. • The study highlights the need for more detailed information on adverse events and long-term outcomes, with 42.4% of respondents noting superficial data on long-term use. • A significant majority (89.7%) of panelists recommend an executive session for panel members only, to foster more transparent and honest deliberations.

A recent survey of voting members serving on the FDA's Medical Devices Advisory Committee (MDAC) indicates potential improvements to the FDA's premarket approval (PMA) process. The study, published in JAMA Network Open, highlights the perspectives of device panel members on pivotal trial design, evidence quality, and internal deliberation processes.
The survey, conducted in 2017, included 64 of 92 panel members and revealed that only 46% believed pivotal trials were frequently well-designed. A significant majority (88.7%) suggested the FDA should consult panel members preemptively regarding trial design, and 84.4% recommended panel review of device labels. These findings suggest a desire among panel members for greater involvement in the early stages of device evaluation.

Panelist Recommendations for Process Improvement

Panelists identified several areas for improvement in the PMA process. Key recommendations include:
  • Early Consultation: A strong consensus (88.7%) favored preemptive consultation with panel members on pivotal trial design.
  • Device Label Review: 84.4% of respondents suggested panel members should review device labels to ensure accuracy and relevance.
  • Executive Sessions: Nearly 90% (89.7%) supported the implementation of executive sessions involving only panel members to promote more candid discussions.

Data and Evidence Considerations

The survey also shed light on the types of evidence panel members find most influential. Written information (83.3%), live presentations (74.1%), and prior professional knowledge (68.3%) were rated as the most important sources. In contrast, public comments were considered less influential (16.6%).
When evaluating devices, 62.9% of respondents indicated they would be more likely to recommend approval for a device already approved in another industrialized country with comparable regulatory regimes, such as Canada or Europe. Additionally, 69.4% would be more inclined to approve a device with prior FDA approval for a similar medical purpose.

Concerns and Limitations

Despite the generally positive view of the FDA's impartiality, panelists expressed concerns about the depth of information provided on specific topics. A significant percentage felt that information was too superficial regarding serious adverse events (34.4%), patients who did unusually poorly (34.4%), and long-term use considerations (42.4%).
The study acknowledges limitations, including potential social desirability bias and the fact that the survey was conducted in 2017. The authors also note that the panels could be made more diverse, as voting members appear to be mainly male, White individuals, and in academic practice.

Implications for the FDA

The findings suggest that incorporating panel member expertise earlier in the PMA process could enhance the quality of device evaluations. While implementing changes such as executive sessions may face legislative hurdles under the Federal Advisory Committee Act (FACA), the study underscores the value of ongoing dialogue between the FDA and its advisory panels to optimize the device approval process.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Study Highlights Inconsistencies in FDA Accelerated Approval Pathway for Cancer Drugs

A recent study reveals that less than half of cancer therapies granted accelerated approval by the FDA between 2013 and 2017 demonstrated clinical benefit in confirmatory trials within five years.
Nearly two-thirds of these drugs were converted to full approval, despite only 43% showing improved overall survival or quality of life, raising concerns about surrogate endpoint usage.

FDA Clarifies Confirmatory Trial Requirements for Accelerated Approvals

The FDA has issued draft guidance clarifying requirements for confirmatory trials needed for drugs receiving accelerated approval.
The guidance specifies that confirmatory trials should generally be underway before accelerated approval is granted, with some exceptions.

FDA and OHRP Issue Draft Guidance on Including Tissue Biopsies in Clinical Trials

The FDA and OHRP have issued draft guidance on including tissue biopsies in clinical trials, offering recommendations for sponsors, investigators, and IRBs.
The guidance emphasizes balancing the risks and benefits of biopsies, distinguishing between mandatory and optional biopsies based on their purpose in the trial.

FDA's Accelerated Approval Pathway Faces Ethical Scrutiny and Calls for Reform

Scholars are debating the ethical implications and potential improvements to the FDA's accelerated approval pathway for drugs targeting serious conditions.
Concerns persist regarding the use of surrogate endpoints and the need for rigorous post-approval trials to confirm clinical benefits.

FDA Strengthens Requirements for Confirmatory Trials, Emphasizing Early Planning and Due Diligence

The FDA is reinforcing the necessity of early planning and thorough due diligence in confirmatory trials for drugs and biologics, impacting accelerated approvals.
New draft guidance from the FDA reflects strategies promoted by the Oncology Center of Excellence (OCE) for efficient drug development.

FDA Advisory Committee Emphasizes Patient-Centered Informed Consent in Clinical Trials

FDA's Patient Engagement Advisory Committee (PEAC) convened to enhance patient understanding and engagement in clinical trials, advocating for shared decision-making.
The committee highlighted gaps in real-world consent processes, emphasizing the need for patient-centric approaches and accessible materials to improve participant comprehension.

Study Reveals Lack of Clinical Validation for Nearly Half of FDA-Authorized AI Medical Devices

A recent study in _Nature Medicine_ found that 43% of FDA-authorized AI medical devices lack publicly available clinical validation data, raising concerns about their effectiveness.
The study highlights the need for the FDA and AI device manufacturers to enhance the credibility of AI devices through rigorous clinical validation studies using real patient data.

Cardiovascular Device Recalls Linked to Insufficient Premarket Testing

A new analysis reveals that many recalled cardiovascular devices lacked rigorous premarket clinical testing, raising concerns about patient safety.
The FDA's 510(k) pathway, used for moderate-risk devices, was associated with a high proportion of Class I recalls, the most serious type.

FDA Issues Draft Guidance to Improve Accelerated Approval Applications

The FDA has released draft guidance aimed at enhancing the quality of applications for accelerated approvals, particularly for oncology drugs.
The guidance emphasizes the importance of timely postmarketing confirmatory studies to reduce clinical uncertainty and ensure patient benefit.

FDA Intensifies Scrutiny on Accelerated Approvals for Cancer Drugs, Mandating Earlier Confirmatory Trials

The FDA is increasing its requirements for accelerated approvals of cancer drugs, emphasizing the need for companies to have comprehensive confirmatory trial plans upfront.
The Oncology Center of Excellence now wants to see confirmatory trials underway when companies submit applications for accelerated approvals, potentially impacting smaller biotechs.

Reference News

[1]
Assessment of FDA Premarket Approval Process and Suggestions for Improvement - JAMA Network
jamanetwork.com · Oct 9, 2024

Survey of 64 FDA device panel members reveals 46% find pivotal trials well-designed, 89% suggest preemptive consultation...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy