510(k)s for Reusable Devices Must Include Validated Data for Cleaning in IFUs
Reusable devices have become more difficult to clean, disinfect and sterilize. FDA is now requiring clear instructions for effective reprocessing.
Tag Archives: 510(k)
FDA Releases Proposed List of 510(k) Exempt Class II Devices
The agency states this list of more than 1000 devices doesn’t have risks that warrant premarket notification.
Five Steps to Medical Device Commercialization
Bringing a product to market in the United States can be complicated, but it can be streamlined with a clear grasp of the process.
I Changed My Medical Device. Do I Need to Submit a 510(k)?
FDA issues two new draft guidances that explain when device or software changes require a 510(k) submission.
Dr. D is Mean Spirited, Seriously?
Regardless, let’s look at stupidity in its highest form.
FDA 510(k) Clearance and Third-Party Reimbursement
Reimbursement strategy can no longer be overlooked when planning the regulatory and clinical strategy for a product, particularly if it is a 510(k) product.
Reimbursement strategy can no longer be overlooked when planning the regulatory and clinical strategy for a product, particularly if it is a 510(k) product.
