Short Answer

Yes. FDA has clear authority and long-standing practice allowing a panel track PMA to proceed—and be approved—without convening an advisory panel when panel input is not deemed necessary, particularly when the PMA “substantially duplicates” information a panel has already reviewed. Multiple PMAs across device types and decades document approvals without a new panel review under section 515(c)(2)/(c)(3) of the FD&C Act, as amended by the Safe Medical Devices Act of 1990 ^{15119343173851637912718655725920513247283}.

Regulatory and Procedural Basis

Statutory/Regulatory Authority

• FD&C Act section 515(c)(2) and 515(c)(3) (as amended by SMDA 1990): FDA may decide not to refer a PMA to an advisory committee if the information in the PMA substantially duplicates information already reviewed by that panel ^{15119343173851637912718655725920513247283}.
• FDA’s advisory committee procedures: FDA “will take a PMA … to a panel upon the request of an applicant, unless FDA finds that the information submitted substantially duplicates information which has previously been reviewed by a panel.” Panel recommendations are nonbinding ^241244246.
• PMA guidance context: Not all panel-track submissions require a panel meeting; panel input is discretionary under 21 CFR 814.44 and related guidance ¹³⁹¹⁴⁰. MDUFA performance goals also distinguish timelines for submissions that do and do not require advisory committee input, underscoring that panel involvement occurs only when FDA determines it is needed ^289290291.
• Breakthrough Devices Program: FDA “must provide for advisory committee input, as it determines appropriate for PMAs,” reinforcing that advisory consultation is discretionary and not universal ¹⁶⁹.
• Post-approval study guidance: FDA “may seek the advice of an Advisory Panel” as needed; panel consultation is optional, not a default requirement ¹⁹²³²⁴.

When FDA May Forgo a New Advisory Panel Review

Common Justifications FDA Cites

• Substantial duplication of previously reviewed information by the relevant advisory panel (the most frequently cited basis in approval records) ^{15119343173851637912718655725920513247283}.
• FDA judgment that external panel input is not necessary given the totality of evidence and the issues at hand; panel recommendations are advisory and nonbinding ²⁴⁴²⁴⁶.
• “As appropriate” standard applied to PMAs, including Breakthrough devices, where FDA retains discretion to consult an advisory committee only when warranted ¹⁶⁹.
• Contexts where prior panel review already addressed the scientific issues in substantially the same way (e.g., same device category or same clinical questions) ²⁴¹²⁴⁴.

In practice, the duplication provision is the clearest and most often documented pathway to proceed without a new advisory panel, but FDA’s broader discretion encompasses other circumstances where panel input is not necessary for decision-making ^244169139.

Evidence from PMA Precedents (1999–2023)

The following FDA PMA decisions explicitly state that the application was not referred to an advisory panel because the information substantially duplicated information previously reviewed by that panel, and the PMAs were approved:

• Series 50 XMO Fetal/Maternal Monitor System (Philips), 2003 — not referred due to duplication; approved ¹⁵¹.
• AngioLink Vascular Closure System (Medtronic), 2004 — not referred due to duplication; approved ¹⁹³.
• UBIS 5000 Bone Sonometer (DMS), 2001 — not referred due to duplication; approved ⁴³.
• VITROS Anti-HBs Assay (Ortho-Clinical Diagnostics), 2000 — not referred due to duplication; approved with conditions ¹³¹⁸.
• M-Vu Algorithm Engine (iCAD), 2012 — not referred due to duplication; approved ⁷³.
• Second Look Analyzer (iCAD), 2002 — not referred due to duplication; approved ⁸⁵.
• Alinity m CMV (Abbott Molecular), 2022 — not referred due to duplication; approved ¹⁶³.
• ADVIA Centaur HAV IgM (Bayer), 2004 — not referred due to duplication; approved ⁷⁹.
• AngioJet Rheolytic Thrombectomy (Boston Scientific), 1999 — not referred due to duplication; approved ¹²⁷.
• AxSYM CORE 2.0 / CORE-M 2.0 / HBsAg (Abbott), 2006 — not referred due to duplication; approved ^18655306181.
• ARCHITECT CORE‑M Reagent Kit (Abbott), 2007 — not referred due to duplication; approved ⁷.
• EC‑3 Intraocular Lens (Carl Zeiss Meditec), 2010 — not referred due to duplication; approved ²⁵⁹.
• Cross‑Seal Suture‑Mediated Vascular Closure Device (Terumo), 2023 — not referred; approved ²⁰⁵.
• HeartSync AED Defibrillator Pads (Graphic Controls/Vermed), 2023 — not referred due to duplication; approved ¹³.
• Orthospec Extracorporeal Shock Wave Therapy Device (Medispec), 2005 — not referred due to duplication; approved ²⁴⁷.
• VITROS HBeAg (Ortho‑Clinical Diagnostics), 2011 — not referred due to duplication; approved ²⁸³.

These examples span in vitro diagnostics, imaging/AI, cardiovascular, ophthalmology, orthopedics, and maternal-fetal monitoring—demonstrating that proceeding without a new panel review is not limited to any single device category or era ^{15119343173851637912718655725920513247283}.

Additional Nuances and Outcomes

FDA Discretion Even When a Panel Met Previously

• AvertD (genetic risk variant detection for opioid use disorder) illustrates that, after an earlier advisory panel meeting, FDA did not convene a new panel when reviewing a subsequent PMA containing information “substantially similar” to what the panel had already reviewed. FDA approved the PMA with conditions (post-approval study, training, patient/provider fact sheets) despite prior panel concerns, underscoring the nonbinding nature of panel recommendations and FDA’s ability to manage residual uncertainty through risk mitigations ^31333234.

Advisory Panel Requests and Nonbinding Recommendations

• While FDA generally will take a PMA to panel upon applicant request, the agency may decline if the submission substantially duplicates previously reviewed information; in all cases, panel recommendations are advisory and do not control FDA’s decision ^241244246.

Timelines and Process Context

• FDA review goals distinguish between submissions that do and do not require advisory committee input; when panel input is required, decision goals run from the panel’s recommendation, confirming that panel review is conditional, not automatic ^289290291.

Post-Approval Conditions Are Common

• PMAs approved without a new panel review frequently carry conditions of approval and post-approval study requirements, reflecting FDA’s approach to manage uncertainty and ensure ongoing surveillance even when a panel is not convened ^{73757678163165131814205207259261264283286}.

Practical Implications

• For sponsors: A panel track PMA may proceed without an advisory panel review when the submission substantially duplicates information a panel has already considered, or when FDA otherwise determines panel input is unnecessary. Proactively mapping your evidence to prior panel-reviewed issues and demonstrating that no new significant uncertainties exist can support a non‑referral decision ^{241244139151193431738516312725920513247}.
• For clinicians and patients: An absence of a new advisory panel review does not signal a lower evidentiary bar; FDA still must find “reasonable assurance of safety and effectiveness,” often with conditions (labeling, training, post-approval studies) to manage residual risks ^{7375767816313205259283}.
• For policy observers: The pattern is consistent over more than two decades, across device types, reflecting a statutory framework that allows efficient, least-burdensome review when external panel input would be redundant of prior panel deliberations ^{15119343173851637912718655725920513247283289290291169}.

Bottom Line

A panel track PMA can proceed—and be approved—without an FDA advisory panel review. FDA’s statutory authority (FD&C Act 515(c)(2)/(c)(3)) and guidance make advisory consultation discretionary, and the agency routinely exercises this discretion when a PMA substantially duplicates information previously reviewed by a panel or when panel input is otherwise unnecessary. Numerous PMAs document approvals under these circumstances across years and device categories ^{15119343173851637912718655725920513247283241244169289290291}.