Overview
FDA Regulatory Support Across the Product Lifecycle
At Michael Best, our FDA Regulatory team helps you navigate the complex landscape of product regulation with confidence. Whether you're developing food, drugs, medical devices, software, cosmetics, or dietary supplements we offer tailored guidance backed by deep industry experience.
Our Approach: Your Partner in Policy and Progress
Strategic Planning & Road Mapping
We start with a comprehensive FDA regulatory assessment, reviewing your current compliance posture against applicable statutes, guidance documents, and enforcement trends. This includes identifying gaps in cGMP, labeling, submissions, and post-market obligations. From there, we design a customized FDA compliance and advocacy roadmap with clear timelines, assigned responsibilities, and milestones—aligned with your business objectives and risk tolerance.
Execution & Implementation
Our team manages the full spectrum of FDA-related activities, including:
- Developing and implementing compliance programs (e.g., SOPs, quality systems).
- Preparing and submitting regulatory filings (IND, NDA, ANDA, 510(k), PMA).
- Responding to FDA inspections and enforcement actions, including Form 483 and Warning Letter remediation. You’ll receive regular progress reports and dashboards to maintain transparency and control throughout the process.
Ongoing Monitoring & Continuous Improvement
We provide:
- Regulatory horizon scanning for FDA rulemaking, guidance updates, and enforcement priorities.
- Periodic compliance audits and refreshes to ensure sustained adherence.
- Post-matter debriefs and long-term compliance planning, embedding continuous improvement into your regulatory strategy.
"The Michael Best team is on top of regulatory developments."
"Through years of experience, the Michael Best team can bring long-standing relationships and familiarity with various regulators and their agencies."
"Michael Best is a fantastic firm. You get quality legal responses on time."
Focus Areas
Comprehensive Counsel Across the Energy Regulatory Landscape
Premarket Strategy & Submissions
We help you classify products, build regulatory strategies, and prepare full FDA submissions.
Design & Import Readiness
Our team reviews design control programs and manages registration, listing, and import notices.
Production & Safety Compliance
We advise you on manufacturing standards, quality systems, and safety reporting requirements.
Enforcement & Risk Management
We assist you with audits, training, inspections, recalls, and regulatory actions.
Experience
Our FDA Regulatory Experience
Medical Devices
We prepare and prosecute a full range of medical device regulatory submissions, including premarket notifications (510(k)’s), Premarket Approval Applications, and de novo submissions; advise on reporting adverse events and conducting corrections and removals (i.e., recalls); and counsel on compliance with the Quality System Regulation. Our attorneys handle highly technical regulatory issues such as design controls, export controls, medical device clinical trials, and Lanham Act litigation.
Medical Software
- We help clients navigate the complex regulation of medical software, including Mobile Medical Apps and telemedicine solutions. We understand how medical software is developed, including the importance of software design controls in the premarket submissions to FDA, as well as the regulatory roles played by the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act.
- Michael Best’s experience includes handling these and other FDA regulatory issues such as cybersecurity, cloud computing services, and software validation.
- We have experience in advanced manufacturing compliance issues such as FDA’s Current Good Manufacturing Practices (CGMPs) and Hazard Analysis and Critical Control Point (HACCP) requirements. Our counsel includes helping clients develop recall strategies; handling import requirements and removal from import alerts; drafting labeling, including “Nutrition Facts” and “Supplement Facts” panels; advising on advertising claims, including permitted structure/function claims; and helping clients understand and comply with evolving regulations under the Food Safety Modernization Act.
- We also assist with preparing New Dietary Ingredient notifications, Food Additive Petitions, and Generally Recognized As Safe self-certifications.
- Our FDA Regulatory team advises pharmaceutical and biomedical clients on CGMP regulations and guidance, including those applicable to Active Pharmaceutical Ingredient manufacturers; premarket regulatory strategies; New Drug Applications; compliance with clinical trial regulations; Hatch-Waxman and orphan drug exclusivity; compliance with Over-the-Counter drug monographs; biosimilar products; and Citizen Petitions.
- Our depth includes technical regulatory issues such as immunogenicity and generic applications for discontinued drug formulations. We also prepare and submit drug registration and listing submissions for clients following FDA’s Structured Product Labeling scheme.
Michael Best has a long, deep history with the agricultural industry, which extends into federal regulatory issues. We advise clients on all aspects of compliance with FDA’s regulation of raw agricultural products and farm-produced foods (such as ciders and juices); handle matters involving the regulation of veterinary drugs and animal feed, including enforcement matters; and advise on regulation by the U.S. Department of Agriculture, such as the Federal Seed Act and labeling requirements for rBST.
- We assist clients with meeting regulatory requirements for radiation-emitting electronic products in medical and commercial settings. We prepare Radiation Safety Product Reports and Annual Reports, and we advise on ongoing compliance with the unique regulatory schemes applicable to laser products, microwave ovens, and commercial X‑ray and other imaging systems.
- Our experience gives us an intimate understanding of FDA’s inspection authority over commercial radiation-emitting electronic products, as well as the interplay between FDA’s medical device regulations and electronic product regulations.
