Imagine this scenario: FDA knocks on your door. They say you changed your medical device but did not tell them. What would
you do? Unlike in the drug world, device companies make changes to existing medical devices all the time. Sometimes they tell
FDA, other times they don’t. And sometimes they get in trouble for making the wrong decision! So how do you decide when to
handle the change internally (via letter-to-file) vs. notifying FDA with a special 510k or PMA supplement? Despite FDA issuing
several guidance’s, the choice isn’t always clear.
Does it matter what kind of change you make? What if you make a cosmetic change, i.e., a color or font size? What if you make
a design change, i.e., the shape or size? What if you make a material change, i.e., swap one material for another or combine two
different materials? What if you make a labeling change, i.e., modify an existing claim or add a new one? What if you make a
manufacturing change, i.e., improving efficiency or reducing rejection rate? The list of possible changes is endless. And your
answer to this question is not nearly as important as your ability to defend it! Do you have a process to handle change?
Beyond FDA, how will your decision influence your product liability? Many “fear the FDA” but this does not foster a productive
relationship. Companies should have a healthy respect for FDA but not fear them. Who should companies fear? Product liability attorneys – they can cause much more damage than FDA ever could! And attorneys often start with change management. So how does a manufacturer create a LTF that will pass mustard at FDA while at the same time not cause product liability nightmares?
Although there are a variety of ways to manage change, many companies make rudimentary mistakes and are forced to reap the
consequences. The result: many companies now impose design limitations on R&D engineers, i.e. only improve the device to the point that we can handle the change via L2F so we do not have to notify FDA. But is there any better way to stifle innovation
than that? How do such practices make the world a better place?
In the end, how you handle change is a business decision not just a regulatory one. The important thing is to conduct the
necessary analysis, determine your options, and evaluate the advantages and disadvantages of each. In this presentation, you
will learn how to make improvements to your devices while at the same time avoiding problems with FDA and liability nightmares in the future. Most importantly, you will learn how to be prepared when the knock comes to your door.
For additional information, check out:
• Column: Best Practices For Medical Device Change Management (Med Dev Online, Oct. 2015) here.
• Webinar: Best Practices for Med Dev Change Mgt: Don’t use FDA as an excuse to hold you back!™ (9/17) here.
• Podcast: Medical Device Change Management: Letter-To-File vs. Special 510k/PMA Supplement here.
• Podcast: Understanding the New FDA Guidance on Changes to a 510(k) (Oct., 2016) here.
• Interview: Changing your medical device: 6 things you need to know (Med Des & Outsourcing, Dec., 2016) here.
For information beyond this topic, visit: Global Medical Device Podcast (GreenLight.Guru), Mike on Medtech (Medical Product
Outsourcing), Medical Design and Outsourcing here, Guerilla Regulatory Strategy (MED Device Online) and Healthcare Packaging here or LinkedIn here.
Michael Drues
