Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s Safety and Performance Based 510k pathway, which offers a pathway for medical device manufacturers to use performance criteria in place of a predicate device for clearance. This option, previously known as an Abbreviated 510k, is only available for a select group of well-understood devices that meet FDA-identified performance criteria to demonstrate the device is as safe and effective as a legally marketed device. Specifically, we address a number of questions, including:

• What is the Safety and Performance 510k?
• How does it differ from other variations of the 510k, such as the traditional version or the Special 510k?
• When should a manufacturer consider using this 510k?
• How does using performance criteria differ from citing a predicate device?
• Is this simply another way to get “me too” products to market quicker or is there more to it than that?
• Is this a incentivized way to have companies use more recent products for the comparison without implementing a hardline “10 year” directive?
• What are the most important takeaways for device manufacturers with regard to this 510k pathway?

If you’d like to review the FDA’s Safety and Performance Based 510(k) program guidance document (finalized September 2019) before listening to this podcast, you can find it by clicking here.

Listen to this episode and see what you think of the Safety and Performance Based 510(k). If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at [email protected] so I can consider discussing them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

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In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s Special 510(k) program, which offers a pathway for medical device manufacturers making modifications to its own legally marketed device. It is a method for device makers to avoid the need to completely resubmit their device as a new device to the agency. Specifically, we address a number of questions, including:

• What is the Special 510(k) program and how does it differ from the standard 510(k) program?
• When is it appropriate for a device manufacturer to use this program?
• In January 2018, we discussed  the then new alternative 510(k) (click here to listen to that podcast). How is this different from that?
• Is this yet another specialized version of the 510(k) to better address the industry needs? Are we creating too many “special case” 510(k) variations or is this ultimately a good thing?
• What are the most important takeaways of this guidance listeners should keep in mind?

If you’d like to review the FDA’s Special 510(k) program guidance document (finalized September 2019) before listening to this podcast,  you can find it by clicking here.
Listen to this episode and see what you think of the Special 510(k). If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at [email protected] so I can consider discussing them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

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

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the brand new (in fact, yet-to-be-launched) Safer Technologies Program (click to review the guidance). Since it was only recently introduced, there are still a number of questions device manufacturers have about the program. With this in mind, we thought it would be a great topic to cover as part of this “Beyond 510(k)/PMA” series. Specifically, we address a number of questions, including:

• What is the safer technologies program?
• How does this program differ from the Breakthrough Designation Program?
• So like BDP, STeP is not a regulatory pathway on its own, correct?
• What are the criteria for eligibility into STeP?
• What are the mechanics of STeP?
• Is STeP an already active program?
• Are the BDP and now STeP part of an effort by the FDA to encourage true innovative technologies and perhaps disrupt the history of incremental innovation within the industry?
• I know the FDA is hosting a pair of webinars to help explain the program. Can you tell us why there are two of them and only a day apart?

Further, there is the mention of two webinars being conducted by the FDA that are relevant to this new regulatory option. You can find them via the following links. (Click the name of the webcast for information about how to view it.)

• Webinar—Safer Technologies Program: Draft Guidance (scheduled for November 6, 2019.)
• Webinar—Safety and Performance Based Pathway Performance Criteria (scheduled for November 7, 2019.)

Listen to this episode and see what you think of the Safer Technologies Program. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at [email protected] so I can consider discussing them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

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

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss two recently issued FDA guidance documents. As they can be coupled together, we discussed both in one podcast. They are:

• Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions (August, 2019) (Click here to read the guidance.)
• Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (August, 2019) (Click here to read the guidance.)

Specifically, we address a number of questions, including:

• Can you please provide a brief overview of what's in these guidances and what their purpose is? 
• Why is PMA, HDE and de novo included but 510k is NOT included in this guidance?
• When is higher risk acceptable and what is the tie-in to the term uncertainty?
• What else is important in these guidances and what are the most important takeaways for listeners?

Listen to this episode and see what you think of these two benefit risk determination guidances. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at [email protected] so I can consider discussing them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

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

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the still relatively new Breakthrough Devices Program (click to review the guidance). Since it was only introduced last year, there are still a number of questions device manufacturers have about the program. With this in mind, we thought it would be a great topic to cover as part of this “Beyond 510(k)/PMA” series. Specifically, we address a number of questions, including:

• What is the purpose of the Breakthrough Devices Program and why does it exist?
• Is the BDP a “pathway” to market like the 510k or PMA?
• How early in the product development lifecycle should we consider a BDP?
• What are the requirements of the Breakthrough Devices Program?
• What are the mechanics of the process?
• What goes into the BDP Pre-Sub Package?
• What is the benefit of BDP status?
• What if you don’t like FDA’s decision, can I appeal?
• Is there a database of BDP devices?
• Should we issue a press release announcing our BDP designation?
• What’s the most important thing to remember about the BDP program?

Listen to this episode and see what you think of the Breakthrough Devices Program. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at [email protected] so I can consider discussing them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

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

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the third most commonly used (although still substantially less than the 510(k) and PMA) regulatory pathway available to medical device manufacturers. Since it is not nearly as common as the two primarily used pathways, the De Novo is not nearly as understood as them. In order to shed light on when this option could be most beneficial or be the best option for a regulatory submission, we attempt to provide an overview of it—a De Novo 101, if you will. Specifically, we address a number of questions, including:

• What is the De Novo regulatory pathway?
• How does the De Novo differ from the PMA and 510(k) regulatory pathways?
• For what situation or type of device is the best case to use the De Novo pathway?
• When shouldn’t the De Novo be used?
• Do you have any suggestions or best practices for using a pre-sub meeting when planning to use the De Novo pathway?

Listen to this episode and see what you think of this regulatory pathway. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at [email protected] so I can consider discussing them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

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

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the subject of my latest Editor’s Letter, which appeared in the June issue of MPO (click here to read that Letter). It features yet another PR hit on the industry along with recommendations on what can be done to fix the problem (click here to read the NY Times Editorial Board statement). Of course, those fixes are rather general in how they are presented, but we dig into each of the three and share our own thoughts on the proposed solutions. Specifically, we address a number of questions, including:

• Should products that are intended to reside in the body for an extended period of time require a PMA pathway? How would that compare to the current protocol?
• Would an "implantable 510(k)" be a middle ground to address the issue—does not require a full PMA, but updates to implantable products can’t go through the standard 510(k) pathway either?
• Might making sub-pathways or application specific pathways open up a problematic can of worms or would application specific approvals be a good idea?
• What are the problems with the current system for post-market surveillance?
• The statement claims that some companies don’t do appropriate post-market surveillance even when ordered. Why wouldn’t the FDA step in when this occurs and withdraw the company’s ability to market a product if they aren’t fulfilling their responsibilities?
• Does the fact that the device industry funding the FDA’s work make them “customers” as the statement claims? Are the fees contingent on speed of approval and the least restrictive pathway possible?

Listen to this episode and see what you think regarding the FDA’s decision to cancel the alternative summary reporting program. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at [email protected] so I can consider discussing them with Mike in an upcoming episode.

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

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the recently announced cancellation of the FDA’s alternative summary reporting program, the reasons it existed, why it was cancelled, and what manufacturers will need to do going forward. Specifically, we address a number of questions, including:

• What is the alternative summary reporting program?
• Was the reporting of the “discovery” of this program fair or was it media hype?
• Why did the FDA recently cancel the program?
• What will medical device manufacturers be required to do now?
• What is the ultimate result of this ban/change?
• What are the takeaways and/or lessons to be learned?

Listen to this episode and see what you think regarding the FDA’s decision to cancel the alternative summary reporting program. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at [email protected] so I can consider discussing them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as iTunes or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

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

In the second part of this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we continue our discussion of a recently released guidance from the FDA, “Nonbinding Feedback After Certain FDA Inspections of Device Establishments,” or more simply, a sort of pre-sub for 483s. The discussion revolves around the timeline for the communication with the agency, types of 483s involved, definition of non-binding, what happens if a manufacturer ignores the FDA recommendation, and the most important takeaways from the guidance.

Listen to this episode and see what you think regarding the FDA’s new guidance for this type of communication with the agency. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at [email protected] so I can consider discussing them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as iTunes or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

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

In the first part of this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the recently released guidance from the FDA, “Nonbinding Feedback After Certain FDA Inspections of Device Establishments,” or more simply, a sort of pre-sub for 483s. The discussion revolves around what this guidance is, what’s new about it, and whether or not it’s actually something we need. Specifically, we address a number of questions, including:

• What’s lead to this new guidance? Do we really need it?
• Why is FDA doing more inspections?
• What is the goal of this guidance/program?
• What is the difference between Form 483 and Warning Letter?
• What is the process described in this guidance?
• What does FDA respond with?

Listen to this episode and see what you think regarding the FDA’s new guidance for this type of communication with the agency. If you’d like to share thoughts and comments with us or have questions on the topic, please reach out to me with them at [email protected] so I can consider discussing them with Mike in an upcoming episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as iTunes or Spotify.

Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me and we’ll try to respond in an upcoming Mike on Medtech podcast.

Send us Fan Mail

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