JVT

Medical Device Forum: Product Changes and the 510(k) | IVT

Changes requiring a new 510(k) are a source of much confusion If a device has significantly changed, a new 510(k) is required The cumulative effect of multiple minor changes may cause the manufacturer to decide that a device has been significantly changed The US Food and Drug Administration does not intend for every change to require a new submission, but that every change be evaluated for such a possibility Manufacturers may incorrectly use “Indications for Use” and “Intended Use” terminology Examples of modifications that may require a 510(k) submission are listed Manufacturers must...

This content is only available to IVT members.
Get help maintaining your knowledge in GMP - Medical Devices. Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.




Product Added Successfully

This product has been added to your account and you can access it from your dashboard. As a member, you are entitled to a total of 0 products.

Do you want access to more of our products? Upgrade your membership now!

Your Product count is over the limit

Do you want access to more of our products? Upgrade your membership now!

Product added to cart successfully.

You can continue shopping or proceed to checkout.