Strategic FDA Regulatory Pathway Planning
Choosing the right FDA regulatory strategy is critical to the success of any medical device. Whether your product qualifies for a 510(k), De Novo, or PMA submission, our FDA consultants provide early pathway analysis, risk classification, and strategic planning to reduce regulatory hurdles and streamline your timeline to FDA clearance or approval.
It is essential to have a strategic and well-thought-out plan when preparing to approach the FDA for the clearance or approval of your medical device. Each interaction with the Agency should be carefully and tactically organized to maximize the information gained at each step in the process. A regulatory strategy provides the roadmap that you need.
Each company and product are unique. Accordingly, the journey taken to obtain FDA approval will also be unique. ProPharma’s team of experienced medical device consultants understands this and develops customized regulatory strategies for every company and every product we work with, focusing on each client's individual needs.
At each step in development, you will gain new information and data that will construct and change the steps that follow. As this happens, your regulatory strategy must transform as well. When this happens, we will work with you to integrate any new information into your overall plan, even if we didn’t develop the initial strategy. We will audit and adjust your regulatory strategy to optimize the pathway to approval for your medical device.
FDA Meeting Support: Pre-Submissions, Q-Subs, and More
The goal of any FDA meeting is to get answers to critical questions and gain insight into the Agency's expectations. To achieve these goals, the meeting must be meticulously planned and executed impeccably, leaving FDA with the best impression of your medical device as well as your company. Making all of the pieces fit together requires the knowledge and experience of an expert. ProPharma's team of expert medical device consultants has the experience, knowledge, and expertise to ensure your FDA meeting is planned and conducted as seamlessly as possible. With more ex-FDA employees, coupled with our expansive team of industry executives and regulatory experts, our team will maximize your chances of successful interactions with the Agency.
Our team of medical device experts and regulatory consultants helps clients plan, prepare, and participate in:
- Q-Submission (Q-sub) interactions, including: pre-submission (pre-sub) meetings, Submission Issue Requests (SIRs), and Informational Meetings
- IDE, De Novo, and PMA discussions
- Medical Device Advisory Committee meetings
We develop FDA-ready briefing packages, prepare your team for meetings, and provide expert representation and regulatory insight throughout the process.
FDA Submissions for Medical Devices
Before a medical device can be sold in the United States, it must often be evaluated and approved/cleared by the FDA's Center for Devices and Radiological Health (CDRH). This approval is achieved by submitting the appropriate application(s) based on your device’s classification. Regulatory requirements vary based on whether your product is a Class I, II, or III medical device. ProPharma’s Regulatory Sciences team can help you determine your device's classification and assist in the preparation and submission of the applicable application(s).
From concept through commercialization, we provide full-service support for FDA medical device submissions, including:
- 510(k) Premarket Notifications: we help determine predicate eligibility, prepare substantial equivalence rationales, guide testing strategies, and compile full submission content for Class II devices.
- De Novo Classification Requests: for novel devices with no predicate, we guide you through this risk-based classification process, including pre-sub interactions, benefit-risk justifications, and development of special controls.
- Premarket Approval (PMA) Applications: our team supports the most rigorous Class III submissions with robust scientific, clinical, and regulatory expertise, including pivotal study design, IDE support, and PMA module development.
- Investigational Device Exemptions (IDE): We provide IDE strategy, protocol design, risk-benefit analysis, and submission preparation to obtain FDA approval for clinical investigations of high-risk devices.
- Breakthrough Device Designation Requests: for eligible innovative products, we prepare compelling designations that emphasize the clinical need and transformative potential of your technology.
- Humanitarian Device Exemption (HUD): for devices intended for rare conditions, we help navigate HDE requirements and FDA incentives for orphan products.
Our team ensures every submission is strategically crafted, fully compliant, and backed by sound scientific and regulatory rationale.
Our FDA submission consulting solutions include end-to-end services, such as:
- Regulatory Pathway Determination: Helping you select the appropriate submission type and strategy based on product classification, risk, and novelty
- Data Gap Analysis and Planning: Reviewing available data and identifying testing needs, labeling requirements, and evidence gaps
- Content Authoring and Compilation: Writing and assembling all required modules, including:
- Executive summaries
- Device descriptions and specifications
- Performance testing results (bench, animal, software)
- Clinical data (if applicable)
- Labeling and instructions for use (IFUs)
- Biocompatibility and sterilization documentation
- eSTAR and eCopy Preparation: Ensuring electronic submissions meet FDA formatting and technical requirements
- Submission Review and Risk Mitigation: Conducting quality reviews, identifying potential issues, and strengthening justifications before submission
- FDA Response Support: Assisting with additional information (AI) responses, deficiency letters, and real-time communication with FDA reviewers
Whether you're preparing your first 510(k) or navigating the complexities of a PMA or De Novo, ProPharma delivers the insight, precision, and regulatory rigor to get your medical device to market with confidence.
Preclinical and Biocompatibility Testing Strategy
A strong preclinical testing program is foundational to regulatory success. Whether you are preparing a 510(k), De Novo, or PMA submission, FDA expects comprehensive evidence demonstrating your medical device is safe, performs as intended, and complies with applicable standards.
ProPharma helps clients design, optimize, and execute preclinical testing strategies that meet FDA requirements while avoiding unnecessary delays or costs.
Preclinical Testing Services Aligned with FDA and ISO Expectations
We support the full range of nonclinical testing activities, including:
- Biocompatibility Testing (ISO 10993): we assess your device's materials and patient contact type to determine applicable biocompatibility endpoints. Our team guides the design and execution of testing programs—or justifies exemptions based on material characterization, literature, and historical data.
- Bench and Performance Testing: from dimensional veriMedicalfication to functional testing under simulated use conditions, we help define and conduct appropriate bench testing strategies to validate safety and performance.
- Electrical Safety and EMC Testing (IEC 60601): for electronic devices, we support comprehensive safety testing, including basic safety, essential performance, electromagnetic compatibility, and environmental stress evaluations.
- Software Verification and Validation: for software-based or software-controlled devices, we help establish Software Level of Concern, develop testing protocols, and prepare documentation per FDA guidance and IEC 62304.
- Usability and Human Factors Engineering: we assist in integrating usability testing into your design control process to reduce use errors and ensure alignment with FDA’s expectations under guidance for Human Factors in device design.
- Sterilization Validation and Packaging Integrity: we guide clients in meeting requirements for sterilization methods (e.g., EO, gamma, steam), SAL validation, and package shelf-life testing per ISO 11607 and FDA-recognized standards.
- Animal Studies: when required, we support preclinical in vivo studies to evaluate safety and biological response, including protocol development, CRO management, and data interpretation.
Reimbursement Strategy and Market Access Planning
Regulatory approval alone doesn’t guarantee market success. We integrate reimbursement consulting into your regulatory plan to help you secure:
- Medicare and commercial payer coverage
- Appropriate CPT and HCPCS codes
- Viable payment pathways and pricing strategy
By aligning your FDA and reimbursement strategies early, we help you reduce barriers to adoption and optimize market access.
Postmarket Regulatory Compliance
Achieving FDA approval is only the beginning. ProPharma supports clients in maintaining compliance with postmarket regulatory requirements, including:
- FDA Medical Device Reporting (MDR)
- Post-Approval Studies (PAS)
- Recalls, corrections, and removals
- Annual reports and regulatory updates
- Labeling and promotional compliance
We also assist with FDA inspections, enforcement actions, and global market expansion strategies.