Design Controls, Deconstructed

Here’s what you need to know about design controls and the critical role they play in your regulatory journey.

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FDA warns of device shortages again due to sterilization plant closures

The FDA today warned of “years of spot or nationwide shortages” of a number of surgical kits and implantable medical devices due to the closure of two medtech sterilization plants that use ethylene oxide (EO) and efforts in Georgia to close a third.

Avoid These Headaches During Regulatory Submissions

Here are some tips on how to avoid deficiencies during final submissions, particularly those involving biocompatibility data.

New Approval Helps Implanting Propel Mini a Little Bit Easier

The Menlo Park, CA-based company said it has received a nod from FDA for the Straight Delivery System for use to place its Propel Mini Steroid implant.

Medtronic Looks to Expand Reach of Artificial Pancreas with New Submission

The Dublin-based company filed a PMA submission to FDA requesting for non-adjunctive labeling for the Guardian Sensor 3, as part of the MiniMed 670G system.

The deadline for ISO 13485:2016 certification is . . . now!

Are your critical suppliers in compliance?

FDA Flips the Switch on Pelvic Mesh Manufacturers

FDA has ordered Boston Scientific and Coloplast to stop selling surgical mesh intended for transvaginal repair of pelvic organ prolapse. Patient advocates say the action was not made soon enough and does not go far enough, but it is a step in the right direction.

Dirty Scopes Are Still a Big Problem

FDA-mandated studies indicate higher than expected levels of contamination on duodenoscopes after reprocessing.

Taking a Deeper Look at Device Certification and Recertification

Experts discuss how to prioritize medical and IVD devices under the new MDR/IVDR in Europe.

Key Medical Packaging Standard, ISO 11607-1/2 Published; More Regulatory Support on the Way

With the EU Medical Device Regulations just over one year away, this latest revision aims to help medical device manufacturers meet the regulation’s General Safety and Performance Requirements.