Class I Medical Device Should have a DHF

If you are developing a class I medical device, you could make a solid argument for not documenting Design Controls and not maintaining a Design History File (DHF). In fact, your argument would be supported directly by FDA Design Control regulations. Very few class I devices even require Design Controls per FDA.

However, if this is the approach you decided to take, I would advise against this. You might argue that documenting Design Controls will only slow you down on your process to bring your class I device to the market. Perhaps.

So why do I recommend documenting Design Controls and maintaining a DHF for your class I medical device?

Design Controls are documented, objective evidence that the product development process has been followed. Design Controls help ensure that User Needs are translated into Design Inputs. That Design Inputs result in drawings, specifications, etc. (Design Outputs). That Design Verification demonstrates the Design Outputs meet Design Inputs. That Design Validation demonstrates the User Needs have been addressed. That the product design was reviewed throughout (Design Review) to ensure the product design is safe and effective. That the product design has been transferred to production (Design Transfer).

Design Controls are proof that you designed the right product, that your product is safe for its intended use, and that your product can be manufactured.

Yes, Design Control documentation and records do take some effort, and time. And if you think it’s worth it to shave a little bit of time in order to get to market faster, this is your choice. As noted, FDA does not require you to document Design Controls for your class I (unless your device is on the special class I devices requiring Design Controls).

But what will happen after you launch? What happens when the product needs to be changed? What happens if you receive a customer complaint?

Okay, Design Controls does not prevent these things from happening completely. But Design Controls, provided you follow the premise and intent rather than just satisfying a checkbox, are intended to find issues during the product development process before being manufactured and used. Helps Ensure Medical Device Design Control Compliance

You might have read about some of our adventures with Today, I’d like to share another chapter in this startup journey.

We had a call with a potential investor / resource. The guy had 20+ years experience in the medical device industry. The purpose of the call was to share a little more about and do a brief product walk through. As we did so, the guy had strong energy about him. Every time we would offer an opinion, comment, or share details about the software, it felt as though he was bringing bad juju and negativity.

Going into the call, I had good energy and an open mind. Right after the call, I felt like someone ran over my dog and slashed my tires.

Now that there has been some time since the call, though, I have had an opportunity to let some of the comments from this guy sink in, trying very hard to scrape away the toxic affects before they sink into my brain.

“Venture backed startups implement enterprise software solutions based on what their investors recommend.”

Maybe in this guy’s experience. This just hasn’t been the case in mine. In fact, of the dozen or so venture backed medical device startups we have worked with over the years, I don’t recall a single one of these companies having any enterprise software in place. Further, the only medical device companies I have worked with throughout my career (which probably totals 4o or more) using enterprise software have been VERY large companies.

“You just have a process flow / spreadsheet that uses FDA Design Control terminology.” (he said in a snarky tone)


I walked this guy through how simple it is to use to input User Needs, Design Inputs, Design Outputs, Design Verification, and Design Validation content. And how the tool automatically builds the traceability matrix for your Design Controls as you go. Yes, I’m biased, but damn, our software development team created a wicked good, simple, easy to use, intuitive way for medical device companies to manage Design Controls.

You see, I’ve sat directly across from ISO and FDA auditors who had technical files and Design History Files in front of them, picking them apart limb from limb. Most of the ripping apart pertained to our inability to clearly and accurately show complete Design Control traceability from User Needs through Design Validation. Of course we had the home grown Excel spreadsheets printed on 28 pages in size 8 font. Cells merged and linked to attempt to demonstrate traceability. Sometimes, I had an hand in creating these wonderfully, painful spreadsheets. Other times, I was there to defend spreadsheets I had no hand in creating. In every case, the audit was painful. In some cases, we survived, relatively unscathed. Other times, findings.

I know our “spreadsheet” is good. I know it will help every one of our customers ensure compliance with FDA Design Control regulations and ensure compliance with Design & Development requirements of ISO 13485. I know that when our customers have up during either a FDA / ISO audit, that they will be able to quickly and easily show complete Design Control traceability.

While we only have a process flow and spreadsheet, it’s a pretty damn important process flow and spreadsheet.

Joy of 510(k) Clearance

Cinco de Mayo was a good day–for many reasons! One of the reasons is that I received notification from FDA that a 510(k) we submitted for our startup medical device client received clearance. Did I mention “5″ is my number? 510(k) clearance on 5/5–pretty sweet!

The project has been rewarding and challenging, as with most medical device product development projects.

I especially found the FDA 510(k) review process to be a bit more challenging than I had expected. A few rounds of “refuse to accept” followed by a reviewer who seemed to challenge just about everything we provided as supporting evidence. Having gone through this experience with a tough and difficult reviewer is something I do appreciate. Working with him actually made the second submission much more complete and smoother (so far) with FDA.

Receiving a FDA 510(k) clearance letter is no small feat. Especially in today’s medical device regulatory market. So much more to do, however. I’ll not dwell on this too long.

FDA accepting comments on planned revisions to current 510(k) modifications guidance

Received the following message in a recent FDA email update:

This is inform you that the FDA is accepting comments until June 4, 2014, for the Report to Congress; Report on FDA’s Policy to be Proposed Regarding Premarket Notification Requirements for Modifications to Legally Marketed Devices. The report announces the agency’s intention to make targeted revisions to the current 510(k) modifications guidance, such as clarifying certain issues, providing additional examples demonstrating when 510(k)s are necessary/not necessary for changes to legally marketed 510(k) devices, and accounting for evolving technology, while retaining the general policy and approach of the current guidance.

The FDA invites comments on this report until the June deadline, through docket number 2014-04930 on

I encourage you to chime in on this.

Made the Deadline – Barely

Several weeks ago, we established that December 31, 2013 would be a good deadline for submitting a 510(k) for a startup client we are working with. As we entered December, this target date seemed very feasible. Each of the team members had their assignments and due dates. I worked on the back end, pulling content and documentation together to build the FDA 510(k) submission packet. All was going pretty smoothly. Maybe too smoothly.

A big part of the plan involved working with the local copy / print shop to print, tab, and organize the documentation for the 510(k). Based on a few recent experiences with this resource, I had developed a good working relationship with one employee in particular. With a couple weeks left in the deadline, I decided to call the copy / print shop to coordinate schedules with this particular person–especially considering the holidays coming up. I found out that the person was out of the office from 12/23 through 12/30 but would be opening the shop up at 7:00am on 12/31. Okay, I didn’t like waiting until then but also didn’t want to waste time training a new person to put together submissions either.

I decided to take the risk and wait for my guy on 12/31.

In the few days before, I went through the submission several times, making a few minor tweaks and edits. The night before, I made sure all the documents were numbered, organized, etc. and put on a USB drive. I also drafted a few simple instructions for the copy / print shop. Although, I knew if my person was there, it should go smoothly. I arrived at the print shop a little after 7:00am. My guy was there and no one else, including customers. I took 15 minutes or so to walk through everything. Seeing confidence on my assistant for the day, I asked when he thought it would be ready for pick up. Response: noon.

I left and headed back to the office to get a little more work done for the next few hours. Sometime around 11:00am, I got a call from the print shop. He was the only employee there for most of the morning and not making as much progress as he had hoped. He pushed it back to 3:00pm. No problem. 12/31/2013 deadline still in good shape.

I checked in a couple hours later. Progress continued to be slow. My guy had to leave at 3:00pm but started training a fellow employee to assist. It should be ready around 5:00pm–just in time for the FedEx pick up.

I called around 4:00pm to talk to the new person working on the 510(k). He had just a few more sections to go. Great. I hopped in the car and made the 30 minute drive. When I walked in a little after 4:30pm, the other employees said there was no way the job would be ready to ship today. They assured me, though, that it would be ready to ship on Thursday (1/2). I stated this was not an option; the 510(k) had to be shipped TODAY. I checked in with the new guy to see where he was in the process. Still quite a bit to go. I let him be and tried to keep calm.

At 4:55pm, I asked how things were going. I was told he was preparing to print and finalize the submission. It might be a little after 5:00pm. Hopefully the FedEx driver could wait a couple minutes. 5:10pm and the printing was happening. The FedEx driver was not there yet. Yeah! There was hope. Within 5 minutes, the driver arrived. He said he had some time to spare and didn’t mind waiting a few extra minutes.

I began reviewing the printed documents. They still needed to be put in order with tabs. I volunteered to go through each of the 762 pages of the submission (I was going to review it anyway). After getting about 50% through the organization, I knew it would be a few more minutes and didn’t want to hold up the FedEx driver any longer, knowing he had additional stops. I asked him if there were other pick-up locations and when he would be at each. I jotted down the next several, including the times he would be at each. This was a little more assuring. There were several options available during the next couple hours. Surely, we would be finished in time.

By a little after 6:00pm, I had finished review and organization of the printed documents. I handed to the print shop guy to punch holes in the paper and box it up. He also had to finish burning a CD with all the documents too. By 6:30pm, the contents were boxed and ready to go. By 6:45pm, I had paid the bill and was out the door. My new destination for FedEx pickup was open until 7:00pm and across town. By 6:59pm, I arrived and handed the box off to ship.

Made it.

And I also learned a few lessons:

  • I put off writing the submission a few days based on when my print shop resource was available. I should have had it all ready to go several days ahead of time.
  • I relied too heavily on a single resource at the last minute to pull the entire submission together. My rationale was this would be better than training someone new. In hindsight, had I gotten the print job in a week or so earlier, I would have had plenty of time to work with and train a new person to do the job.
  • Having a second resource trained to assist with FDA submissions will be beneficial for future projects.
  • Don’t wait until the last minute.

Mixed Emotions About FDA

I’ve shared some recent trials and tribulations on current medical device product development projects and FDA submissions. The saga continues. Last week, I received a round of questions from FDA on a 510(k). Yes, we made it through the RTA phase and into the substantiative review. Some of the questions were familiar themes from this submission, having already fielded FDA questions on the same topics during RTA stage of review. As I read the questions, I was more than a little frustrated and agitated. I felt as though the evidence provided, teleconferences with FDA, and email correspondence suggested that what was provided would meet FDA expectations. I thought wrong. A couple of the topics seemed to be somewhat time consuming to address. Project timeline out the window!

And as I received the FDA questions, I was putting the finishing touches on a complimentary submission. A second submission that had direct ties and linkage to the content of the first. As I took a break from compiling the second submission to read 510(k) questions, I immediately put the breaks on. Based on FDA comments, there was no point in sending the second 510(k) until the questions were answered. Second project timeline be damned too!

Did I say frustrating?

But at the same time, as a potential consumer and recipient of medical device technologies, reading the level of depth and detail of the FDA 510(k) questions was also encouraging. The types of data and information expected is a little bit remarkable and definitely thorough. More thorough than just about any other 510(k) submission I’ve read or been a part of. As a consumer, I felt that FDA is doing the proper due diligence to ensure new devices introduced in the U.S. are as safe and effective as possible.

I immediately shared the list of questions with the medical device startup. It was a Friday, and not exactly the news any of us wanted going into a weekend. But as the startup CEO lamented, FDA establishes the rules for medical device companies. There is little we can do except to react and adjust. And that’s just what we are doing.

Mad Rush to FDA

Now that the U.S. Federal Government is back in business, will there be a mad rush for medical device companies to send submissions, such as 510(k)s, to FDA? Did the two week shutdown create a backlog at FDA? Have companies been waiting on this day? What about all those submissions that were already in the queue prior to October 1?

I can report that since the shutdown, I have been in communication with FDA on a 510(k) submission. Keep in mind the user fees associated with this were paid prior to shutdown. It’s been encouraging to know that FDA seems to be active reviewing submissions during the past couple weeks.

I can always admit that the shutdown was a little bit of a blessing of sorts too. We have been working on another 510(k) submission and are not quite ready to submit to FDA. Knowing that government shutdown prevented us from providing this submission to FDA was buying me a little time. Now I have no more excuses.

FDA Is Running During Government Shutdown

I posed a question a few days ago about whether or not FDA is operating during this government shutdown. The FDA posted this information on the medical devices section of it website:

As of October 1 and continuing until the enactment of an FY 2014 appropriation or Continuing Resolution, FDA operations will cease EXCEPT FOR the following:

  • Emergency work involving the safety of human life or the protection of property;
  • Criminal law enforcement work; and
  • Activities funded by carryover 2013 user fees.
During this time, FDA will not have legal authority to accept 2014 user fees.  
This means that until operations resume, FDA will NOT collect any 2014 user fees and will NOT be able to accept any new regulatory submissions that require a fee payment. 

Further, I’ve heard that if user fee related items had been paid and accepted prior to shutdown, FDA would continue supporting these submissions. However, I also heard that FDA was not able to review submissions, such as 510(k)–even if user fees were already paid. Regardless, it sounds like a real mess and that no one knows for sure.

I have a 510(k) in with FDA now. The day of the government shutdown, I was preparing a response to address a “refuse” RTA FDA review. As I prepared and organized the documents to ship to FDA, I wondered if this was in vain. Would FDA receive and review the response during the shutdown? Or would I have to wait until Congress gets their issues resolved.

I got my answer within a couple days of sending the response. I shipped it out on October 1. On October 3, FDA sent notification that response was received. On October 4, the FDA reviewer sent notification that the response and 510(k) had been accepted past RTA phase.

All good news. It seems as though FDA is not completely shut down.

It is very clear, though, that FDA is not able to accept new submissions and user fees.

Fast and Furious Medical Device Product Development

Do you remember when ketchup came in a glass bottle and seemed to take forever to trickle out–especially when it was a new bottle? I think it was Heinz who had a brilliant ad campaign to emphasize the time it took for ketchup to come out of the bottle. Their slogan was “. . . The best things come to those who wait . . .” Now finding ketchup in a glass bottle is a little more challenging. Most of the time ketchup comes in a container that allows you to squeeze in order to get your ketchup delivered to your fries as fast as possible.

Ketchup is just one example of course. Pick anything else. We can’t get our coffee fast enough. Our internet speed is too slow. Speed limits on the highway should be faster. Faster, faster, faster! I’m surprised that no one has thought of super fast food. Go with me for a second on this one. Imagine that I place my order and pay for it via text or a smartphone app before I get to my favorite fast food place so that when I arrive, the food is ready for pick up. Yeah, it will happen.

Is faster better? What happens to the quality when the speed increases? Logic suggests that the factor of time does have an influence on the overall quality. What’s that you say? Excess time could also have a diminishing return. Continual increases in time does not translate into continual improvements in quality. True. And that’s kind of the mystery to solve.

Which for ketchup and fast food, for now the quality is good enough at the current rate of speed.

But what about medical device product development? Is fast and furious a good thing? Should we push for faster and faster and faster? Do we realize that the speed factor can have a negative impact on our product development efforts? And are these risks you are willing to take? Or do you need twice as much time? If so, will your quality really be that much better? Will your product development efforts go that much smoother?

To me, this is a very interesting conundrum.

It’s now October. Ten months ago, I started a medical device product development project with an entrepreneur / CEO. The goal he made very clear was that before the end of 2013, he wanted to have the device on the market. The device is semi-complicated. It’s an electronic gadget driven by custom firmware. Plus, there are plastic parts and pieces, disposable components, and so on. Before kicking off the project, I had a few conversations with the CEO about project timeline. He reiterated time and again one year, one year, one year. I told him that while theoretically this schedule was possible, 18 months was more realistic–mostly because of FDA wildcard. So we talked about FDA and 510(k) process. After hearing about all of this, the CEO said he thought FDA would only take 90 days to provide clearance and that we should plan accordingly. He saw no reason why one year was not feasible. I tried to explain all the ups and downs that are likely to happen during medical device product development. That if I could plan for it, then it would be avoided. But it’s the things we won’t think of that will be challenging. After discussion, I did feel it was realistic to get to a point when a 510(k) submission could be submitted before the last 90 days of 2013. And since he believed 90 days with FDA would suffice, then this goal of getting to market before 2014 was in fact doable.

Yes, as of this post, there are less than 90 days left in 2013 and a submission has not gone it yet. However, we did have a period of over a month where we had to regroup and find a new design and development team. Despite this, the 2013 goal has still been in place. And we are so close. We are finishing up IEC electrical safety testing and should conduct head to head performance testing within a week or so. I anticipate being 510(k) ready within a couple weeks.

We have been fast and furious with the medical device product development. Some days things have gone smoothly. Others, not so much. From my perspective the fast has created some of the furious. I realize the importance of urgency and being driven toward an aggressive goal. When everything feels like an emergency, though, the sense of urgency loses its meaning and gets washed out. Of course every project manager would prefer a longer schedule–I’m no exception. I guess what I’m trying to say is that we have been running through this thing pretty quickly, sometimes taking business risks that if only we had waited another day or two might have resolved themselves. It feels furious almost every day. And lately, because of all the moving parts and pieces that must come in sync all together now, the fast suddenly feels slow–almost backward.

Fast and furious and medical device product development? Yeah, I think that’s fine. The challenge, in my opinion, is knowing when to slam the acclerator to the floor, when to ease off a bit, and when to apply the brakes.

When FDA Provides a Refuse Response on 510(k) It’s Time to Learn

I recently posted about FDA’s refuse to accept approach to 510(k) reviews. After the second (and hopefully last) RTA refuse response from a FDA reviewer which somewhat contradicted (in my opinion) the first review, I decided to communicate my concerns with the branch chief. The FDA branch chief was prompt to respond and suggested we discuss my concerns via teleconference.

Prior to the call, I was optimistic that the branch chief might just suggest that what was already provided was sufficient. Okay, you might say that’s more delusional than optimistic. The call happened and went, well neither good nor bad. Actually, the call was productive. We reviewed and discussed each of the questionable items in depth, identifying what we need to do to address the shortcomings. So I guess on that account, the call went as well as I could possibly hope.

I would definitely had preferred that the 510(k) passed the RTA review with an accept response. But going through this has been helpful. I don’t know yet how this will impact the current 510(k). I do believe going through a couple RTA rounds with FDA will make the next 510(k) submission that much stronger.

How Do You Feel About FDA 510(k) Refuse to Accept?

Have you had any experiences regarding the new(er) FDA approach for reviewing 510(k) submissions? The approach I’m referring to is the “refuse to accept” or RTA checklist. In a nutshell, once a 510(k) submission is received by FDA, there is an initial RTA review conducted to ensure that all elements of the 510(k) have been provided. This initial review happens within 15 days of receipt, and the sponsor is notified that their submission has either been accepted or refused. If accepted, the 510(k) goes to the next reviewer who will dig into the substance. If refused, a RTA checklist is provided to the sponsor, indicating where the submission shortcomings are.

Pretty sweet, right? Quick feedback from FDA on your 510(k). Yeah, not so fast.

The RTA feedback is provided pretty quickly. However, this review is described as a more administrative type of review. And based on my own experience and some anecdotes provided by colleagues, FDA seems to be seeking reasons to refuse 510(k)s and push them back to the sponsor to correct or update. I can tell you from my own experience, it definitely seems as though there is some nitpicking going on. I’ll elaborate.

In early July, I submitted a 510(k) for a fairly simple and straight forward disposable, single use device. The predicate was a very good match. Of course I followed FDA guidance documents, checklists, etc. for what to put into a 510(k). I also reviewed the RTA checklist as I compiled the 510(k) documents. Of course I felt the submission was complete. Why would I send it to FDA if otherwise? A couple weeks after submitting, I received a “refuse” response from FDA. The response included the RTA checklist with reviewer comments. I reviewed and obviously had a difference of opinion. I scheduled a call with the reviewer, where we walked through each concern one by one. I discussed an action plan for each and got buy in from the reviewer. She even confirmed the buy via email. It took us a few weeks, but we were able to address the shortcomings and reviewer comments.

In early August, the RTA response was submitted. A couple weeks later, I received a phone call from a FDA reviewer–someone different than the person who first reviewed the submission. He had a few questions, I had a few of my own. He said he would get back with me and did so the next day, this time with a few more questions. I was kind of confused at this point. Some of the things he asked about was marked as fine by the first reviewer. Other points of discussion pertained to how we addressed the issues identified by the first reviewer. Keep in mind, we discussed the specific action plan with the first reviewer who agreed with our plan. Any way, the second reviewer said he needed to discuss the issues with the branch chief and would get back with me.

He did later that day by sending another “refuse” response and the RTA checklist. I reviewed his remarks and was kind of baffled. He marked a couple things as unacceptable that were non-issues for the first reviewer. And the he was not satisfied with the objective evidence provided to address reviewer one’s concerns. I requested a phone call to discuss each item, which he obliged. During the call, I asked why FDA had changed their response from acceptable to unacceptable on some of the items and why the evidence provided to address the first reviewer’s concerns was determined insufficient. The reviewer told me I should just disregard the first reviewer’s comments, indicating they did not count and that he started the review over from the beginning.

Really? The first review didn’t count. We’re starting over? Sorry, but WTF! Do you think I can just say to the startup “. . .  Well, we the last month didn’t really count. Our project is delayed and we are no closer to getting to market. It’s no big deal though. We’re starting the review over from scratch.” And then I wonder if this is how it’s going to be when I send my next RTA response to FDA.

I decided to do something about it. I contacted the branch chief and FDA ombudsman. The concern I expressed is the inconsistency in responses and direction from one reviewer to the next. I’m waiting on a response and will let you know what I learn. The decision to send a message to the branch chief was a little difficult. I already have one submission with FDA. Two others are planned soon. But at the same time, just rolling over and taking it didn’t seem like an option either. It helped to learn that a few colleagues are also dealing with similar issues.

Let’s just say it seems as though FDA is still learning how to apply the RTA process. And it’s definitely clear the opinions vary from reviewer to reviewer. It also seems as though there is a decent about of review on the actual substance happening in this phase. I know it’s the FDA way these day, no matter how frustrating.

Medical Device Accelerator in Memphis, TN

The medical device industry has several geographic pockets. Memphis, TN is one of these, especially in orthopedics.

I recently read about this medical device accelerator located in Memphis called ZeroTo510. They seem to have all the key pieces for a medical device concept to get off the starting blocks. Part incubator, part educator, part investor, part mentor. The program is geared towards helping medical device inventors and entrepreneurs get to a FDA 510(k) submission, while providing guidance and direction along the way

While I have no idea how successful this program has been, the model is very intriguing. So much so that I wonder if something like this could be piloted in central Indiana.

Medical Device Product Development in 12 Months

Can it be done? I guess before you answer, it might be helpful for me to share a few more details.

  • Device is pretty clearly a class II with dozens of potential predicates.
  • This is essentially a “me too” product.
  • The project seems to be well-funded.
  • Product development has been outsourced to firms with expertise.

So do you think this medical device can be brought to market in 12 months time?

I believe so. Granted there isn’t much wiggle room in the schedule. And of course, there will be a FDA 510(k) submission involved. But getting this product ready for launch in a year seems feasible.

We had the project kickoff on November 26, 2012 and really got started the first part of December. So far, we have finished the planning phase, including definition of clear, objective design input requirements. The rest of the schedule is laid out. Yes, we all know that medical device product development is full of uncertainties and surprises.

I’ll keep you posted as to our progress along the way.


Helping Medical Device Inventors Get Started

Do you remember a couple years ago when I put the message out there that Creo Quality was looking to meet “garage inventors”? Ever since, we have been making connections with medical device inventors, entrepreneurs, and startups. It’s been fantastic!

In fact, right now, I am working closely with two very early stage medical device inventors. Both ideas are novel and seem to solve a real problem. In both cases, the inventors seem to be great people who are open to suggestion and are not afraid to admit that there are just things about this process they don’t know.

In both cases, I shared the Building a Business Case questionnaire with the inventor and received the completed responses within a few days. The completed questionnaires are very helpful for a couple reasons–the biggest of which is the fact that the inventor actually took the time to provide responses is an indicator that he is willing to see this thing through. A leap of faith–maybe. But I’ve had plenty of so-called inventors whom I have not heard from since sending the questions.

And for an aspiring medical device inventor who wants a little help and guidance on what to do and when to do it, I’m telling you now you will get some of my time for FREE if you are willing to complete the Buidling the Business Case questionnaire. The links above should guide you to downloading the survey and you can email it to me if you want a little help.

Reprocessing Medical Devices Scares Me

I’m investigating an issue for a client on a medical device of theirs which appears to have been reprocessed by a third party vendor. A sales rep recently discovered that one of the company’s products had been reprocessed because it had reached expiration date. The reprocessor took the product and repackaged and re-sterilized it and charged the hospital.

Here are some immediate concerns I had when discovering this:

  • The product was originally sterilized by the original manufacturer (my client) via gamma sterilization. The reprocessor sterilized with ethylene oxide.
  • The reprocessor did not list a new expiration date. A representative from the hospital claims he was told “it’s good forever”.
  • The reprocessed product was listed with the exact same part number as it was from the original manufacturer.
  • The reprocessor did not include the product’s instructions for use.
The customer willingly sent the suspect product back. I had a chance to evaluate it. When I opened the pouches, I removed each component and visually examined. One of the components had a significant curve–one that is not supposed to be there–which could have an impact during its use. And in the event there is an issue during a procedure, there is a good chance the original manufacturer (my client) will receive the complaint.

I realize that FDA allows reprocessors to do their thing, with one significant caveat. The reprocessor is required to receive 510(k) clearance first.

So I checked the 510(k) clearances for this particular reprocessor. They have not received 510(k) clearance to reprocess this product.

I’m completing my investigation and will be making several recommendations to my client.

Frankly, as a potential patient, reprocessed medical devices scare me. Maybe it’s because I know too much about the process for bringing medical devices to market. I mean single-use medical devices are designed and tested prior to reaching hospitals. The packaging, sterilization, shelf-life, performance, and so on have all been proven. For a third party who does not have access to any of this data on the product to come in and repackage, re-sterilize, and suggest that the single-use device is as good as new is just preposterous.