New Year, New FDA Regulations

FDA Medical Device Validation

As we get into the New Year, it is pertinent to be aware of new laws and regulations that may affect our industry in 2018. As an example, The Food and Drug Administration (FDA) recently announced plans for a new approval process to speed medical device products’ entry to the U.S. market. The new approval process will allow certain devices to go to market with initial approvals, with further evidence to assess performance coming later. While the process will not apply to all categories of medical devices, low-risk and well understood technological areas such as ultrasound and cholesterol blood tests will be affected first. When interviewed, FDA commissioner Scott Gottlieb described the new process as a “progressive” move to promote innovation and clear barriers to new business in the medical-device industry. Furthermore, Robert G. Hauser, a cardiologist and former device-company executive whose primary research interests have included device safety, said “investment in medical device technology is suffering because of FDA delays.”

As details of the new approval process are still being developed, it is important for us in the medical-packaging community to stay one step ahead! This means as the product to market timeline speeds up, packaging activities too must speed up by being involved even earlier in the project timeline. Here at PCL, our industry knowledgeable packaging engineers are here to aid in every step of the process whether it be at the planning & design concept, design development, process development & validation, or design validation phases. Additionally, our ISO 17025 accredited lab offers industry leading turnaround times and is a one-stop shop for ALL your packaging needs!

For more guidance, items to consider at each step, pro tips, and more on how PCL can help aid your packaging activities throughout the product to market process, watch out for our upcoming eBook, "The Medical Device Launch Roadmap" coming early in 2018!

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