Recent FDA reforms — such as the federal agency’s lean management model and new Combination Products Policy Council — plan to simplify combination product review. However, getting a medical device to market is still a lengthy process — on average, it takes 12 years to get a product into a pharmacy — and complex.
Developing a regulatory strategy helps you align FDA regulatory requirements with your business model so you can overcome some of the challenges associated with combination product review.
Simplify Combination Product Review
The FDA has tried to streamline the combination product review process in recent years. Sponsors of a combination product request can now send two marketing applications at once and submit a Request for Designation to determine which center has jurisdiction over their application.
A lead center will often consult and collaborate with other centers as part of the review process, too. However, only a comprehensive regulatory strategy helps you navigate the regulatory landscape.
Collaborative Regulatory Strategies
Mark D. Kramer, President of Regulatory Strategies, Inc., says that a successful regulatory strategy cannot be created in a “vacuum” and needs to involve a cross-functional team composed of regulatory, marketing, medical, engineering, reimbursement and manufacturing staff.
You should also call on the expertise of external influences, like partner companies, suppliers and consultants.
Use a Regulatory Expert
The FDA has issued guidance documents that define combination products and their constituent parts, as well as tell you how to obtain a jurisdiction determination and submit a second marketing application.
Still, the process is complicated for organizations unaware of the latest federal regulations.
Most manufacturers want to reduce the time it takes to get FDA approval without getting bogged down in red tape, something a regulatory expert or consulting firm can help with.
A regulatory expert or consulting firm guides you through the regulatory process. You can determine which of the FDA’s regulatory paths for combination products is the best choice in your circumstances, minimizing risk and delays and ensuring speedy FDA approval.
Regulatory requirements change rapidly and can be difficult to decipher; manufacturers need a strategic plan so they can specify the intended purpose of their combination product, outline safety concerns and target the right market.
Develop a regulatory strategy that maximizes your chances of getting your combination product to market. Contact us at Quality Solutions Now (QSN), and we’ll create a long-term solution that benefits your organization.