Afleveringen

  • The Most Dangerous Devices to Hit the Market

    The Most Dangerous Devices to Hit the Market

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re taking a look at several devices that unfortunately ended up being quite dangerous even though they made it to the market and were used by healthcare professionals. Some of these may have been brought up previously the Netflix documentary, The Bleeding Edge, was discussed but others are new. Specifically, the following questions are addressed:

    First Mike, can you provide a definition of what a dangerous device is?As I mentioned in the introduction, we previously discussed the 2018 documentary The Bleeding Edge, which featured some dangerous devices. How far back do dangerous devices go though? Are these a relatively newer problem?Another publisher’s website featured a slideshow of four dangerous devices. But do you have any sort of idea of how many others there may have been?With all the regulations in place, regulatory professionals that work in this industry, and FDA oversight, how do any “dangerous devices” make it to the market?Should we be adding regulations to address these devices so they don’t happen again?What are the takeaways?


    Listen to this discussion and see what you think of the system we have to attempt to prevent these types of devices from getting to market. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

    For more medtech news and information, visit www.mpomag.com.

  • Headline-Generating Medical Device Safety Concerns

    Headline-Generating Medical Device Safety Concerns

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re reviewing a few stories in the news that tie into the safety of medical devices. First, a story regarding plastic syringes made in China that were deemed not to be used by the FDA. The other story is about a report indicating third-party testing lab data may be unreliable and, in some cases, falsified. Specifically, the following questions are addressed:

    Can you give some additional insights into each of these news items and explain how they are connected?Given the medtech universe and all the different types of devices it encompasses, a syringe seems somewhat low on the list of advanced devices. What can we learn from this device?If a basic device like a syringe cracks or doesn’t function properly, how realistic is it that the issue is reported to the manufacturer or FDA?If my device includes a syringe but it’s not manufactured by one of the companies that received a warning letter (or maybe it’s not even made in China), do I have anything to worry about?Do you have an example to help illustrate this?Looking beyond syringes, obviously virtually all device manufacturers rely on testing data. If the FDA is warning makers about third-party labs providing fabricated, duplicated, or otherwise unreliable data, what should companies do who use third-party testing labs?What are the takeaways?


    Listen to this discussion and see what you think of these concerns regarding device safety. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

    For more medtech news and information, visit www.mpomag.com.

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  • Analyzing ECRI’s 2024 Top 10 Health Technology Hazards

    Analyzing ECRI’s 2024 Top 10 Health Technology Hazards

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re looking at the latest annual list put out by ECRI, an independent authority on healthcare technology and safety, on their top 10 health technology hazards for 2024. The full list is available at the organization’s website, which is at www.ecri.org. Specifically, the following questions are addressed:

    What is ECRI and what is the purpose of this list?Number one on the list is medical devices for the home. Specifically, they indicate medical devices may pose usability challenges for home users, risking misuse and patient harm. Can you please explain why this would be number one on the list? What’s the issue with usability?The second item on the list involves inadequate or onerous device cleaning instructions. So this isn’t really about cleaning protocols, but rather the instructions that indicate how the device should be cleaned. What’s the concern here?The fourth item is regarding the sustainability trend. Specifically, ECRI states this one as overlooked environmental impacts of patient care endanger public health. This is more of a product design issue, correct?Another hot topic item, number five calls out insufficient governance of AI used in medical technologies risks inappropriate care decisions. Is this indicating we should avoid relying too heavily on decisions indicated by AI and ensure clinician overview of findings?Still another hot button, cybersecurity issues ranks at number six on the list. Specifically, it is listed as ransomware targeting the healthcare sector remains a critical threat. This ties in directly to the significant efforts being put forth to ensure connected devices have a cybersecurity plan in place, correct?What are the takeaways?


    Listen to this discussion and see what you think of these items on the list or what was missed and should have been on the list. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

    For more medtech news and information, visit www.mpomag.com.

  • Examining Institutional Review Boards

    Examining Institutional Review Boards

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re looking at IRBs, or institutional review boards. We’re taking a look at what these are, how they relate to medical device approvals, and why they are important. Specifically, the following questions are addressed:

    Could you please explain what an IRB or institutional review board is?If I’m a device maker and am looking to conduct a clinical trial for one of my devices, do I need IRB approval?Are there situations in which I would not need an IRB approval prior to a clinical trial?Do you have suggestions on selecting an IRB? What I would want to look for and perhaps what I’d want to avoid?What information do I need to provide to the IRB for its review?What kind of timeline should I expect with the IRB review process?Do I have any recourse if the IRB review comes back not in my favor?What are the takeaways?


    Listen to this discussion and see if you’ve gained insight for your next interaction with an IRB. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

    For more medtech news and information, visit www.mpomag.com.

  • Reimbursing Breakthrough Designation Products

    Reimbursing Breakthrough Designation Products

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the journey that’s occurred with regard to getting reimbursement tied to the FDA’s Breakthrough Designation Program (BDP). It’s been planned, called off by CMS, put into proposed legislation, but we still don’t have a definitive solution. Specifically, the following questions are addressed:

    Can you please explain what the Breakthrough Device Designation program is?When did the reimbursement component come into play with regard to the BDP?Why is it important for a BDP device to have reimbursement tied to it upon regulatory approval/clearance?What concerns did CMS have regarding the reimbursement portion of the BDP?This year, we’ve seen proposed legislation from Congress to force CMS to pay for devices that gain the BDP designation. What’s going on with these?Does the ridiculously low number of devices associated with the TCET demonstrate an underlying problem with all of this?What about the proposed “reasonable and necessary” caveat that’s also associated with the TCET? Do we need to clarify what this means or just replace it entirely?What are the takeaways?


    Listen to this discussion and see how you feel about the latest proposed reimbursement plan. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

    For more medtech news and information, visit www.mpomag.com.

  • Strengthening the 510k Program

    Strengthening the 510k Program

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at guidances published by FDA regarding the 510k regulatory pathway. The subject matter of the three were: best practices for selecting a predicate device, the need for clinical data in a submission, and evidentiary expectations with implanted devices. Specifically, the following questions are addressed:

    Can you please provide a brief explanation of the 510k pathway?Why is the agency attempting to strengthen the program? What is their ultimate goal?With the predicate device, we recently had a podcast on using a recalled device for a predicate. When they say “best practices,” are they suggesting avoiding doing that?What other best practices are tied to the predicate device selection?How do you gather clinical data on a device that’s not cleared or approved and just being submitted to the FDA?For what situations is the agency considering clinical data in a submission and why?For the third guidance, can you explain what this is? What are evidentiary expectations with implanted devices?What do these mean to you? What will they mean to medical device manufacturers?What are the takeaways?


    Listen to this discussion and let us know what you think of any or all of these guidances. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

    For more medtech news and information, visit www.mpomag.com.

  • Medical Device Manufacturing Recalls

    Medical Device Manufacturing Recalls

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at the recent rise in recalls that are being tied back to manufacturing issues. The discussion explores the recall mechanism itself and then move to the details behind the numbers. Finally, a strategy for mitigating risk is shared to help manufacturers avoid the potential for recalls. Specifically, the following questions are addressed:

    Before we get into the reasons around why, can give a very brief overview of what exactly a device recall is?Medical device recalls aren’t new, so why are we taking a closer look at them today?Should we have been able to see this coming? Was this foreseeable?Are all of these recalls, or really any recalls, equal in terms of how serious they are?Can you explain what is meant by faulty manufacturing? Are machines making bad parts and it’s not being recognized?Who’s job is it to set the specs?Why the sudden increase? In 2022, recalls hit their lowest level in a decade. So what changed that now in 2023, they are at such a high level?Moving forward, what could we do/should we do to mitigate these risks and minimize residual risk for devices in the future?What are the takeaways?


    Listen to this discussion and see if you feel more comfortable about avoiding a recall. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

    For more medtech news and information, visit www.mpomag.com.

  • AI Predetermined Change Control Plan

    AI Predetermined Change Control Plan

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a look at a guidance from the FDA that explains how product sponsors can submit a predetermined change control plan for artificial intelligence and machine learning technologies. These are critical as these types of software evolve over time to enhance the benefits they bring. Specifically, the following questions are addressed:

    Can you please give a brief overview of what an AI or ML product is?Can you explain how this product can, quote evolve, as the FDA puts it?Now can you cover what a predetermined change control plan is and how it relates to the AI/ML product in this discussion?So why is this important? Why is it important to enable an AI or ML device to evolve?Can you offer real world examples of how this all works?What are the takeaways? Or in this instance, perhaps you could reiterate the most important tasks a company needs to keep in mind for their AI/ML products.


    Listen to this discussion and see if you think this guidance addresses the issues associated with AI/ML. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

    For more medtech news and information, visit www.mpomag.com.

  • Can You Use a Recalled Device as a Predicate?

    Can You Use a Recalled Device as a Predicate?

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine the FDA policy regarding the use of a recalled device as a predicate in a 510k submission. Is it a good idea? What considerations are there for doing so? Specifically, the following questions are addressed:

    First, would you please explain the various levels of a recall as it relates to a medical device and what each level means?Can you quickly remind us of how a predicate device is used in a 510k submission?Given we’ve laid the groundwork, can you now please explain how a recalled device can be used as a predicate device?Is there any argument that can be made for having it be valid to use a Class 1 recall device as a predicate?Do you think a recall should invalidate a device from being used as a predicate? Or, would you ever suggest a recalled device to a client to be used as a predicate?I know some have argued for a “cap” to a device being used as a predicate, for example, nothing older than 10 years. Should there be a minimum amount of time a device should be on the market in clinical use to be able to be used as a predicate?What are the most important takeaways?


    Listen to this discussion and see if you think using a recalled device as a predicate is a good regulatory strategy. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

    For more medtech news and information, visit www.mpomag.com.

  • Leading Issues from FDA Inspections (or History Repeating Itself)

    Leading Issues from FDA Inspections (or History Repeating Itself)

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the 483s and warning letters that resulted from FDA inspections in 2022. The list is alarmingly similar to previous years and the discussion explores why that’s the case. The discussion also centers around ways device manufacturers can avoid making many of these same mistakes that get other companies into trouble with the agency. Specifically, the following questions are addressed:

    Can run through the top reasons for 483s and warning letters?Can you provide some examples of CAPA problems and offer suggestions for avoiding them?Like CAPAs, design controls accounted for more than 12% of the list. Can you provide examples of these violations and suggestions on how to avoid them?Third among the top was complaint handling, almost 11% of all violations. Do you have examples of these and tips for avoiding them?Are these top three problems really identical to what we’ve seen in previous years? Are these the same mistakes again?What are the most important takeaways with regard to today’s discussion?


    Listen to this discussion and see if you might be vulnerable to a 483 upon your next inspection. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

    For more medtech news and information, visit www.mpomag.com.

  • To Regulate or Not to Regulate
LDTs, Part 2

    To Regulate or Not to Regulate…LDTs, Part 2

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue to discuss lab developed tests (LDTs) and whether or not the FDA should have the authority to regulate them. How would FDA oversight impact quality and timeliness of care? How do LDTs relate to what happened with Theranos? Specifically, the following questions are addressed between the two parts of this podcast presentation:

    Can you start today’s conversation by explaining why we’ve selected this topic for today’s discussion? Has there been an update to this debate?What is an LDT?Why do labs develop their own LDTs?Can you provide a couple of examples of LDTs?Currently, are LDTs regulated? Why and who is involved?You mentioned LDTs are low risk, but are LDTs truly low risk? What do you mean?Is there precedent we can examine for using enforcement discretion to not regulate LDTs?What is the relationship between LDTs and Theranos?What is your recommendation for companies developing LDTs and/or IVDs?Do you have suggestions for improving the status quo with regard to LDTs?What are the important takeaways from this discussion manufacturers should keep in mind?


    Listen to this two-part discussion and see how FDA oversight of LDTs could affect your company’s products. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

    For more medtech news and information, visit www.mpomag.com.

  • To Regulate or Not to Regulate
Lab Developed Tests, Part 1

    To Regulate or Not to Regulate…Lab Developed Tests, Part 1

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the debate over lab developed tests (LDTs) and whether or not the FDA should have the authority to regulate them. What would this type of oversight do to the need for speed with these types of tests? Would FDA supervision make things safer and also avoid future situations like the Theranos debacle? Specifically, the following questions are addressed between the two parts of this podcast presentation:

    Can you start today’s conversation by explaining why we’ve selected this topic for today’s discussion? Has there been an update to this debate?What is an LDT?Why do labs develop their own LDTs?Can you provide a couple of examples of LDTs?Currently, are LDTs regulated? Why and who is involved?You mentioned LDTs are low risk, but are LDTs truly low risk? What do you mean?Is there precedent we can examine for using enforcement discretion to not regulate LDTs?What is the relationship between LDTs and Theranos?What is your recommendation for companies developing LDTs and/or IVDs?Do you have suggestions for improving the status quo with regard to LDTs?What are the important takeaways from this discussion manufacturers should keep in mind?


    Listen to this two-part discussion and see how FDA oversight of LDTs could affect your company’s products. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

    For more medtech news and information, visit www.mpomag.com.

  • What Happens When the EUA Period Ends?

    What Happens When the EUA Period Ends?

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at what happens to products on the market under the FDA’s emergency use authorization (EUA). Once the EUA period ends, what happens to these products? As President Biden has already declared the pandemic to be over, this timeframe will be approaching quickly. Specifically, the following questions are addressed:

    Could you please explain what an EUA is within the regulatory context of the pandemic?Under whose authority is the pandemic deemed over such that the status of devices on the market under EUAs become a concern?How will the FDA handle these EUA products?What should companies be doing now if they want to keep their products on the market after the EUAs expire?Are there any considerations companies should keep in mind with an EUA product?Are there any reasons a company may not want an EUA product to go through a full regulatory review?What are the most important takeaways with all of this for medical device manufacturers?


    Listen to this episode and see if the end of EUAs impacts your company. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

    For more medtech news and information, visit www.mpomag.com.

  • What Does 510k Exempt Actually Mean?

    What Does 510k Exempt Actually Mean?

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA’s use of the word “exempt” and what it means for medical device manufacturers. During this discussion, we look at the relationship between 510k exempt and Class of device. Specifically, the following questions are addressed:

    Could you please explain what 510k exempt actually means?Are all Class I medical devices exempt and all Class II devices not exempt?What’s the difference between Class I exempt and Class II exempt?What is the difference between general controls and special controls? How are these relevant to exempt status?Could you give some examples of products that are Class I exempt and explain why they are afforded that status?Now could you do the same for Class II products that are exempt and give reasons why?What are the most important takeaways with all of this for medical device manufacturers?


    Listen to this episode and see how 510k exempt may affect your company’s products and future regulatory submissions. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

    For more medtech news and information, visit www.mpomag.com.

  • How Can Off-Label Use Be Promoted?

    How Can Off-Label Use Be Promoted?

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at how a company can promote the off-label use of a medical device. It would seem to go against FDA regulation to do so, but there are acceptable methods that can be utilized that essentially promote the off-label use. Specifically, the following questions are addressed:

    Since this discussion came out of the last podcast on intended use, can you give a very quick summation of that rule?Can you speak to the relationship between intended use and off-label use?When it comes to a medical device manufacturer promoting the off-label use of a device, how can that happen without raising a red flag with the FDA?To what degree can a promotion take place? Could it be an advertisement, collateral material provided to a doctor, or messaging from a sales person? Or all of the above?Can you share a couple real-world examples of acceptable off-label promotion?Where is the cut-off? In other words, what should companies be sure they AREN’T doing with regard to off-label promotion?What are the most important takeaways with all of this for medical device manufacturers?


    Listen to this episode and see if you’re able to promote an off-label use of one of your devices. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

    For more medtech news and information, visit www.mpomag.com.

  • FDA's Intended Use Rule’s Relation to Labeling

    FDA's Intended Use Rule’s Relation to Labeling

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA’s Intended Use rule and how it impacts device labeling. It is also revealed how labeling can be used by medical device OEMs as a competitive advantage. Specifically, the following questions are addressed:

    Could you please explain exactly what we mean by labeling, and further, clarify the difference between high level and low level labeling?How can labeling, both high level and low level, be used as a strategic advantage?Could you please explain the difference between intended use and indications for use?What is this intended use rule and why is it important to medical device manufacturers?What is meant by manufacturer's objective intent?Do you have examples you can provide?What are the most important takeaways with all of this for medical device manufacturers?


    Listen to this episode and see how Intended Use affects your device labeling. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

    For more medtech news and information, visit www.mpomag.com.

  • Gaining an Advantage Through Class II Special Controls

    Gaining an Advantage Through Class II Special Controls

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the Special Controls that are part of the FDA’s regulatory requirements for Class II devices. During the conversation, the purpose of these Special Controls is presented. Additionally, ways to use these regulatory requirements to gain a competitive advantage is also discussed. Specifically, the following questions are addressed:

    Would you please explain what we mean by Special Controls? What are they, and how and when are they used?What makes these “special”?Would you mind providing some real-world examples of Special Controls?How do Special Controls vary based on the regulatory pathway? In other words, how are they different from 510k vs a de novo?With regard to Special Controls, what are the most important takeaways to keep in mind?


    Listen to this episode and see if you can leverage Special Controls to gain a competitive advantage. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

    For more medtech news and information, visit www.mpomag.com.

  • FDA’s Refuse to Accept Policy for 510(k)s

    FDA’s Refuse to Accept Policy for 510(k)s

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA’s policy known as Refuse to Accept (RTA) as it relates to 510k submissions. Sadly, some companies are rejected due to Refuse to Accept as many as three times, which is a completely avoidable problem. Specifically, the following questions are addressed:

    Please start with an explanation of the FDA’s review process. What happens after the agency receives a submission?This is the third Refuse to Accept guidance from FDA. Can you provide an overview of all three and explain how they should be used?What was the agency’s goal in releasing these guidance documents?Do you have examples you can share of submissions rejected on RTA review?The agency has tried to modernize with the offering of some etools. Can you explain what these are and what advantages and disadvantages there are to using them?How should a medical device manufacturer view these documents and how should they use them?What are the options for a device maker upon the rejection of a submission?What are today’s takeaways with regard to Refuse to Accept guidance from the FDA?


    Listen to this episode and see if you better understand how to avoid a Refuse to Accept rejection. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

    For more medtech news and information, visit www.mpomag.com.

  • Initiating a Voluntary Medical Device Recall

    Initiating a Voluntary Medical Device Recall

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we examine medical device recalls. More specifically, the focus of the discussion is on voluntary recalls, why they occur, and why companies need to be ready to conduct a recall. The FDA’s involvement with a recall is also presented as well as what “recall ready” means. Specifically, the following questions are addressed:

    Can you start by explaining what a voluntary recall is and why or when it’s used?Is there any differences in the process for a voluntary recall across any of FDA’s categories, such as pharma, medical device, food, etc.?Is there a non-voluntary recall (or one that is ordered)? If so, how is that different?The FDA states a company within a product distribution chain needs to be “recall ready.” What does this mean?What are the steps in a voluntary recall?Is the FDA involved in a voluntary recall beyond being notified? If so, how?How do you ensure everyone who needs to be contacted about a recall is reached?What are the most important takeaways companies need to keep in mind about voluntary recalls?


    Listen to this episode and see if you better understand voluntary recalls. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

    For more medtech news and information, visit www.mpomag.com.

  • A Letter to File Deep Dive

    A Letter to File Deep Dive

    · Medtech Matters

    In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we take a deep dive on the letter to file tool that companies can use for certain situations. But what are those situation and how do you know when it’s appropriate to use this pathway? Also, how do you ensure you are using a letter to file correctly so as to avoid challenges that could arise with the FDA? Specifically, the following questions are addressed:

    While we’ve mentioned letter to file a number of times in other podcasts, can you please take a minute to explain exactly what a letter to file is and when it should be used?Why is a letter to file important?When does a medical device company submit a letter to file to the FDA?Does the FDA provide any guidance on a letter to file or offer a template to use for it?What goes into a Letter to file?Can you provide some real-world examples of when to consider using a letter to file versus not using one? Does the type of change matter?Are there situations where using a letter to file could result in an adverse effect to what was intended?When it comes to a letter to file, what are the most important takeaways for listeners to keep in mind?

    Listen to this episode and see if you better understand the point of the letter to file and when to use it. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at [email protected] and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

    For more medtech news and information, visit www.mpomag.com.

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