Therapeutic Expertise
Regulatory strategy is not device-agnostic. The cleared predicates, FDA guidance documents, review division expectations, and clinical evidence requirements vary significantly by therapy area. ADB Consulting has worked across a broad range of device categories — including high-complexity areas where regulatory strategy is as important as the technical development program.
Discuss Your DeviceTherapy Categories
510(k) and PMA submissions for cardiovascular devices including implantable rhythm management, cardiac monitoring, vascular access, and structural heart devices. OPC-based clinical study design for cardiac device PMA programs. FDA's Cardiovascular Devices program office familiarity — predicate selection strategy, performance testing protocols, and clinical evidence requirements by device type.
510(k) and De Novo strategies for orthopedic implants, spinal systems, and sports medicine devices. Biocompatibility testing programs (ISO 10993), mechanical performance testing against ASTM orthopedic standards, and clinical evidence strategy for devices seeking clearance in a mature predicate landscape. Design controls and risk management for implantable systems with patient-specific dimensions.
FDA regulatory strategy for AI/ML-based devices under the agency's evolving SaMD framework. Device classification analysis, SaMD risk category determination, Predetermined Change Control Plan (PCCP) development, and cybersecurity integration for connected AI systems. Pre-submission strategy for novel AI algorithms where no existing predicate exists.
510(k) and De Novo submissions for IVD devices including laboratory analyzers, point-of-care tests, and molecular diagnostic platforms. FDA's CDRH In Vitro Diagnostics program guidance, analytical and clinical performance validation design, and predicate strategy for IVD submissions in rapidly evolving diagnostic categories.
PMA and De Novo strategy for neurostimulation devices, spinal cord stimulators, deep brain stimulation, and neurological monitoring systems. Long-term implantable device design controls, IDE clinical study design for OPC-based PMA programs, and human factors engineering for complex neurology device interfaces.
510(k) and PMA strategy for respiratory devices including ventilators, sleep apnea devices, anesthesia systems, and pulse oximetry. FDA's guidance for respiratory device performance testing, patient interface human factors, and post-market surveillance programs for devices in intensive care environments.
510(k) strategy for surgical instruments, electrosurgical systems, endoscopes, and laparoscopic devices. Biocompatibility testing programs for reusable and single-use surgical instruments, sterilization validation, and packaging validation for sterile surgical systems.
Regulatory strategy for wearable devices, remote patient monitoring platforms, and mobile medical applications. FDA Digital Health Center of Excellence guidance, software function classification under FDA's Software Policy, cybersecurity under Section 524B, and HIPAA business associate compliance for connected health platforms.
Why It Matters
Every FDA review division has device-specific guidance documents, cleared predicate precedents, and performance testing expectations that are not documented in the general 510(k) guidance. A regulatory consultant who knows the cardiovascular device program's expectations for hemodynamic testing data writes a 510(k) differently than one approaching the submission from general principles alone — and the difference is reflected in whether the submission receives deficiency letters or achieves first-cycle clearance.
ADB Consulting's team has worked across the therapy categories above, building the device-specific regulatory knowledge that accelerates submissions and reduces the cycle time between development completion and market authorization. We bring this institutional knowledge to every engagement, along with the strategic regulatory skills that apply across device types.
If your device doesn't fit neatly into any of the categories above — or if it sits at the intersection of multiple categories — we welcome the complexity. Some of the most interesting regulatory strategy work involves devices that don't have a clear classification path and require building a novel approach with FDA through the pre-submission process.
Discuss Your Device CategoryGet Started
Book a free 30-minute discovery call. We'll discuss your device category, regulatory status, and how ADB Consulting's therapy-specific expertise applies to your program.