Navigating Drug, Biologic and Medical Device Regulatory Strategies

Contributing Author: Mamta Puri-Lechner
In a recent webinar, Kanchana Iyer and Mamta Puri-Lechner, Senior Consultants at Halloran Consulting Group, shared their insights on regulatory strategies for drug, biologic, and medical device products, drawing on their extensive experience helping clients of various sizes transition from academia to commercial applications. They covered key aspects of the regulatory process, including the importance of early FDA engagement, strategy development, and navigating approval pathways.C

Drug and Biologic Development: Regulatory Pathways

For drug and biologic products, there are three primary regulatory pathways: developing a new drug, modifying an approved drug, and creating a generic. Each path involves different FDA interactions and specific marketing applications, which are crucial for getting a product to market. Early alignment with FDA guidelines and understanding the distinct requirements for each pathway can greatly simplify the approval process and minimize delays.

Medical Device Classification in the US

In the U.S., medical devices are classified based on the risk they pose to users, which dictates the regulatory requirements for each device. Devices are classified into three categories: Class I (low risk), Class II (moderate risk), and Class III (high risk). For each classification, manufacturers must engage with the FDA early in the development process and provide clinical evidence to demonstrate the device’s safety and effectiveness. The FDA offers different approval pathways depending on the device’s class, including the 510(k) pathway for many Class II devices and the Pre-Market Approval (PMA) process for Class III devices.

Dental Device Classification and FDA Database

Dental devices generally fall under Class II, but classification can vary depending on the specific device. If there is any uncertainty about the classification of a dental device, starting with a search in the FDA’s database can be a useful first step. If there is still uncertainty, requesting a formal classification from the FDA may be necessary. Proper classification is essential for ensuring compliance and can help avoid regulatory hurdles later in the development process.

Developing a Regulatory Strategy for Product Development

A well-thought-out regulatory strategy is essential for the successful development of drug, biologic, and medical device products. Early communication with the FDA helps clarify requirements, reduces risks, and enables faster approvals. The FDA offers expedited designations for drugs, such as breakthrough therapy and fast track approvals, which can significantly shorten the development timeline. A global strategy for clinical trials is also important, especially when planning for international markets. High-quality data submissions and preparation for FDA meetings are critical to ensure a smooth review process.

The Medical Device Development Process

The medical device development process involves understanding a product’s intended use and ensuring it meets regulatory requirements. Early risk assessments are necessary to identify potential issues, and compliance with design controls, quality management systems, and risk management processes is required. There are five distinct phases in medical device development, and each phase should include design reviews to ensure that the product is progressing according to plan and meeting the necessary standards for approval.

The Value of Early FDA Engagement

Engaging with the FDA early in the development process can significantly de-risk the product approval journey. Early meetings with the FDA allow manufacturers to ask critical questions, gain feedback, and clarify design and clinical study parameters. These interactions help ensure that the FDA has the necessary information to review the product and can ease the approval process when it comes time to submit an Investigational New Drug (IND) application or medical device application. Various types of FDA meetings, such as pre-IND and Type B meetings, offer opportunities to discuss specific aspects of a product's development.

Regulatory Strategy and Commercialization

Developing a regulatory strategy is essential not just for obtaining product approval but also for successful commercialization. It is important to consider regulatory requirements early in the research phase to ensure a smooth transition from laboratory development to market. Whether for academic spin-offs, new startups, or more established companies, understanding the regulatory framework is key to minimizing delays and bringing products to market efficiently.

In conclusion, a well-planned regulatory strategy, early engagement with the FDA, and a thorough understanding of the requirements for drug, biologic, and medical device development can significantly enhance the chances of success in product commercialization.

Watch the full webinar here.