Will FDA Changes Lead to a Better Combination Products Review System?

You need to decipher ever-complex guidelines and a labyrinth of legislation before you can get a combination product to market. Correct product labeling and training is no longer enough; your company requires comprehensive workflows to mitigate the risks involved in the manufacturing process. The FDA hopes to iron out the kinks in combination product review with a new lean management model, which was announced in March. But what does this mean if you already struggle with FDA-imposed rules and regulations?

Improve Products for End Users

While the FDA hasn’t revealed the full impact of their lean management plan, the agency says the changes will “enhance communication and coordination” among those who “oversee the development, review, and approval of combination products.”

This effort, like 21 CFR Part 4, which forms part of the FDA’s Code of Federal Regulations, could improve combination products for your end users, ensuring designs are safe and free from errors.

Your combination products will now undergo a “more cohesive, more collaborative and more systematic” review that could provide users with peace of mind.

Eliminate User Hazards

The FDA wants to analyze your existing manufacturing practices and plan a “future state that eliminates waste and maximizes value.” A greater focus will be placed on a combination product’s interface; you could be expected to minimize — or even eliminate — user-related hazards by modifying the design of your product.

This shouldn’t come as a shock: The agency already endeavors to minimize product flaws that could cause harm to patients or jeopardize medical treatment.

However, stricter implementation of human factor testing, robust risk management and design optimization could now further limit user errors.

Understand the Compliance Process

The FBI recently released a 21-page guide to combination product design and development, which strives to simplify the complicated compliance process. The report outlines the importance of risk analysis to identify critical tasks and reviews the training methods and human factors that mitigate potential hazards.

The FDA hopes the guidance will speed up lengthy combination product reviews; 70 percent of innovators experience a delay after submitting a product. The agency’s lean management model will identify “delays and redundancies” in the current system.

“Lean management works,” says the FDA. While proposed changes are still in the preliminary stage, expect the reforms to impact the way you manufacture and test your combination products in the future.

Want to improve your chances of getting a combination product to market? Call in a professional. Here at Quality Solutions Now (QSN), we can help you make sense of the FDA’s lean management model — a worthwhile investment if you don’t want to risk noncompliance.