Medical Device & Pharmaceutical Regulatory Attorneys
OFW Law’s Washington DC attorneys represent medical device and pharmaceutical companies before FDA in regulatory submissions, enforcement defense, and compliance matters.
Medical device manufacturers, pharmaceutical companies, and biotechnology firms need experienced FDA regulatory attorneys to navigate complex compliance requirements, enforcement actions, and approval processes. OFW Law’s Washington DC team represents clients before FDA in premarket submissions, post-market compliance, enforcement defense, and regulatory strategy matters.
Comprehensive Support Throughout Medical Product Lifecycle
We partner with medical device manufacturers, pharmaceutical companies, and life sciences innovators at every stage of product development, commercialization, and post-market compliance.
Pre-Development & Regulatory Strategy
Establish the optimal regulatory pathway and compliance framework before significant development investment.
- Product classification and risk assessment
- Regulatory pathway determination (510(k), PMA, De Novo, IND, NDA)
- Predicate device identification and substantial equivalence strategy
- Pre-submission meeting preparation and FDA interaction
- Competitive landscape analysis and patent considerations
- Development timeline and budget planning
Clinical Trials & Investigation
Navigate investigational requirements for human clinical studies and preclinical development.
- Investigational Device Exemption (IDE) applications
- Investigational New Drug (IND) submissions
- Clinical trial protocol development and review
- Institutional Review Board (IRB) submission guidance
- Good Clinical Practice (GCP) compliance counseling
- Clinical data collection and analysis requirements
- Adaptive trial designs and protocol amendments
- Safety monitoring and adverse event reporting
Premarket Submissions & Approval
Prepare comprehensive regulatory submissions to secure FDA marketing authorization.
- 510(k) premarket notification preparation and submission
- Premarket Approval (PMA) application development
- De Novo classification requests for novel devices
- New Drug Application (NDA) submissions
- Biologic License Application (BLA) preparation
- Breakthrough Device designation applications
- Priority Review and Fast Track requests
- FDA question responses and deficiency letter management
Manufacturing & Quality Systems
Establish compliant manufacturing operations and quality management systems.
- Quality System Regulation (21 CFR Part 820) compliance
- Current Good Manufacturing Practice (cGMP) programs
- Manufacturing facility registration and listing
- Design control procedures and documentation
- Process validation and verification protocols
- Supplier qualification and control
- Manufacturing process change management
- Design and manufacturing transfer planning
Commercialization & Launch
Ensure compliant market entry with appropriate labeling and promotional strategies.
- Product labeling and Instructions for Use (IFU) review
- Promotional materials and advertising compliance
- Sales and marketing training on regulatory requirements
- Medical affairs and scientific communication planning
- Post-approval study commitments and tracking
- Distribution and supply chain compliance
- Import/export licensing and documentation
- Product launch regulatory readiness assessment
Post-Market Compliance & Surveillance
Maintain ongoing regulatory compliance and respond to post-market requirements.
- Medical Device Reporting (MDR) systems and procedures
- Adverse event reporting and trending analysis
- Post-market surveillance studies
- Annual reporting and periodic updates
- Product modifications and supplement submissions
- Field corrective actions and recalls
- Complaint handling and investigation procedures
- Continuous manufacturing and quality monitoring
Enforcement Defense & Crisis Management
Respond effectively when FDA enforcement actions or compliance issues arise.
- FDA Form 483 observation responses
- Warning letter and untitled letter response strategies
- Import detention and refusal resolution
- Recall initiation and management
- Consent decree negotiation and compliance monitoring
- Injunction defense coordination
- DOJ and OIG investigation response
- Crisis communication and remediation planning
Medical Products Regulatory Experience Across Device Classifications
Our regulatory attorneys guide clients through FDA compliance and approval processes for diverse medical product types across all risk classifications.
Class III Devices (Premarket Approval Required)
- Implantable cardiac devices (pacemakers, defibrillators, stents)
- Hip and knee replacement systems
- Spinal implants and fusion devices
- Automated insulin delivery systems
- Novel surgical robotics and navigation systems
- Life-sustaining ventilators and respiratory support
- Intraocular lenses and ophthalmic implants
- Heart valve replacement devices
Class II Devices (Typically 510(k) Clearance)
- Diagnostic imaging equipment (MRI, CT, ultrasound, X-ray)
- Surgical instruments and electrosurgical devices
- Patient monitoring systems (ECG, blood pressure, pulse oximetry)
- Infusion pumps and drug delivery devices
- Orthopedic fixation devices and surgical tools
- Dental devices and equipment
- Powered surgical instruments
- Diagnostic ultrasound systems
In Vitro Diagnostics (IVD)
- PCR and molecular diagnostic test systems
- Immunoassay analyzers and reagents
- Point-of-care testing devices
- Companion diagnostics for targeted therapies
- Laboratory developed tests (LDTs)
- Blood glucose monitoring systems
- Clinical chemistry analyzers
- Infectious disease diagnostic tests
Software as Medical Device (SaMD) & Digital Health
- Clinical decision support software (CDS)
- AI and machine learning diagnostic algorithms
- Mobile medical applications
- Remote patient monitoring platforms
- Telemedicine and telehealth systems
- Picture archiving and communication systems (PACS)
- Electronic health record (EHR) integrated devices
- Wearable health monitoring devices
Pharmaceuticals & Biologics
- Small molecule drugs (New Drug Applications)
- Biologic license applications (BLAs)
- Biosimilar products
- Gene therapy and genetic medicines
- Cell therapy products
- Combination products (device-drug, device-biologic)
- Orphan drug designations
- Generic drug applications (ANDAs)
Cannabis-Derived Medical Products
- CBD pharmaceutical drug development
- THC-based pharmaceutical products
- Hemp-derived wellness and supplement products
- Cannabis-device combination products
- Medical marijuana program compliance
- Cannabis delivery device regulation
Discuss Your Medical Product Regulatory Matter
OFW Law’s Washington DC attorneys represent medical device manufacturers, pharmaceutical companies, and life sciences organizations in FDA compliance matters, regulatory submissions, enforcement defense, and customs compliance for medical products.
Initial consultations available to discuss your FDA regulatory needs, enforcement matters, or medical product import compliance issues.
Industries We Represent in Medical Products Matters
Our regulatory attorneys guide clients through FDA compliance and approval processes for diverse medical product types across all risk classifications.
Primary Industries
- Medical Device Manufacturers (Class I, II, and III)
- Pharmaceutical and Drug Manufacturers
- Biologics and Biosimilar Developers
- In Vitro Diagnostic (IVD) Companies
- Digital Health and Software as Medical Device (SaMD)
- Combination Product Manufacturers
Specialized Sectors
- Cannabis and CBD Product Companies
- Veterinary Medical Products
- Cosmetics and Over-the-Counter (OTC) Products
- Compounding Pharmacies
- Regenerative Medicine and Cell Therapy
- Medical Research Institutes
- Clinical Research Organizations (CROs)
- Contract Manufacturing Organizations (CMOs)
Meet Our Team
FOCUS AREAS
- Advocacy & Public Policy
- Cannabis
- CBP Compliance
- CBP Enforcement
- Digital Health
- Due Diligence
- Enforcement & Litigation
- Executive & Regulatory Advocacy
- Inspections
- Litigation
- Medical Devices & Products
- Pharmaceuticals & Biologics
- Supply Chain
- Trade Associations
- Forced Labor and UFLPA
- Entry of Experimental Pharmaceutical Products and Investigational New Drugs
- Trade Remedies (Antidumping and Countervailing Duties), ITC Investigations, and USTR Matters
- Trade Policy and Regulations
Faqs About Pharmaceutical Regulatory Attorneys
What does a medical device regulatory attorney do?
Medical device regulatory attorneys prepare FDA submissions like 510(k) and PMA applications, respond to warning letters and Form 483 observations, and guide manufacturers through the approval process. They ensure products meet FDA safety and effectiveness standards while navigating complex federal regulations.
What is the difference between 510(k) clearance and PMA approval?
510(k) clearance demonstrates a device is substantially equivalent to an existing predicate device and typically takes 90 days for FDA review. PMA approval is required for high-risk Class III devices, requires clinical data proving safety and effectiveness, and takes 180+ days for FDA review.
How can attorneys help with FDA warning letters?
Regulatory attorneys analyze warning letter violations, develop corrective action plans, prepare formal FDA responses, and negotiate with FDA officials. Experienced counsel prevents escalation to consent decrees, injunctions, or product seizures.
What should I do if my medical product is detained by U.S. Customs?
Contact regulatory counsel immediately. Attorneys review the detention notice, determine if it’s FDA or CBP-related, prepare admissibility responses, and coordinate with both agencies to release compliant products. Quick response is critical as detained products may be destroyed.
When should I hire an FDA compliance attorney?
Hire an FDA attorney when developing new devices or drugs, preparing regulatory submissions, responding to warning letters or 483 observations, facing import detentions, planning clinical trials, or conducting M&A due diligence. Early involvement prevents costly delays.
What is a De Novo classification for medical devices?
De Novo is a pathway for novel, low-to-moderate risk devices with no predicate for 510(k) clearance. If FDA finds a device not substantially equivalent, manufacturers can request De Novo to establish it as Class I or II, creating a new predicate for future submissions.