FDA 510(k) applicants should ensure that their submissions meet RTA screening criteria to avoid RTA letters that can delay their US market commercialization plans. Just have a look on the below five key reasons provided to avoid the RTA letter:
𝙁𝙞𝙫𝙚 𝙠𝙚𝙮 𝙧𝙚𝙖𝙨𝙤𝙣𝙨 𝙛𝙤𝙧 𝙧𝙚𝙘𝙚𝙞𝙫𝙞𝙣𝙜 𝙖𝙣 𝙁𝘿𝘼 𝙍𝙏𝘼 𝙡𝙚𝙩𝙩𝙚𝙧
1. Failure to comply with FDA guidance: Applicants should adhere to recommendations listed in the agency’s guidance documents on formatting Traditional, Special and Abbreviated 510(k) submissions. Some device sponsors may not understand how to compile and format their 510(k) submissions.
2. Failure to supply an eCopy: FDA 510(k) applicants must submit an electronic (eCopy) of their 510(k) applications to the agency.
3. Failure to understand the difference between different types of 510(k)s: There are three types of premarket notification submissions: Traditional (most common), Special (less common) and Abbreviated (rare). Some applicants do not understand the differences between these types of 510(k)s and submit the wrong type.
4. Failure to identify FDA guidance applicable to your device: In their submissions, 510(k) applicants should identify FDA guidance documents if applicable to their devices’ specific product code. If such information has not been included in a submission, FDA reviewers will deem your submission lacking.
5. Failure to provide test data applicable to your device: Virtually all 510(k) applications submitted for FDA review must include some type of test data (e.g., electromagnetic compatibility (EMC), electrical safety, sterilization, biocompatibility, shelf-life, mechanical performance, etc.)
"Why don't we see a more widespread use of virtual doctors? We see some here and there, but with the technology already available, why don't we see more?"
I put myself in the physicians shoes.
-Would I ADD computer screen virtual meetings with patients to my existing patient load? Where would I get the time to do that?
-Would I have to cut my existing patient load to add time for virtual meetings? If so, would I charge the same? Can I justify the same charge? Would the quality be the same?
Researchers have told us that over 90% of communication is non-verbal. This is why Webex meetings take longer than face to face meetings. It takes longer to understand something. in face to face encounters we capture feelings, perhaps see expressions that the camera would not catch, hear and feel things the microphone may not hear. We can sense despair, fear, and anxiety, which could lead us to better suited treatment paths.
Will quality of care go down with more virtual doctor visits, or up as some say? Or is it just about cost?
I would like to hear your thoughts.
Application-wise, right now I am looking for a material with similar strength and fatigue properties as titanium that may be easier to use in manufacturing, potentially injection molding.
Click on the following link to register for the webinar:
You will learn how the global technology leader in minimally invasive robotic-assisted surgery, Intuitive Surgical:
• Automated data integration processes, eliminating risk of manual errors
• Centralized label lifecycle management based on a single, compliance-ready platform for easy design, reliable production and cost effective dynamic change management in response to business needs
• Assured data integrity by sharing critical label data from core components of SAP ERP
• Centralized management and distributed production for labels
• Fully automated unattended label production from within SAP ERP
• Had support for changing labeling requirements driven by regulatory, supply chain, local language, postponement strategies and organizational profiles.
Register for this live webinar on 15th March. You can also watch the recording.
The webinar will be presented by Gyan Agarwal, Senior Program Manager, Digital Engagement at Intuitive Surgical and Chris Lentz - VP of SAP Business Development at PRISYM ID.
Please share the registration link with your colleagues http://bit.ly/2orIPKW.
Intuitive Surgical and PRISYM ID: Integrating Labeling with SAP for Label Content Integrity and Control
Date: 15 March | 8:30AM San Francisco/11:30AM New York/3:30PM LondonFor the label designer, creating the layout of a medical device or pharmaceutical label is just part of the story. The content required to populate the label including images, static
does anyone has insights into the interpretation of Article 45 of the MDR (Article 41 in the IVDR). It sais that as part of the market surveillance activities, there is a change that the competent auhorities will review the technical documentation of a product and that this may happen off- or on-site. I think this can be interpreted in two ways - either the CA will review the technical documentation during an audit of the NB or the CA audits the technical documentation during a NB audit of a manufacturer. Do manufacturers need to consider an authority sitting on the table during a NB-surveillance audit? Looking forward to see your thoughts on this.
All the Best
Dozens of U.S. patients may have to undergo surgery to replace their Medtronic heart defibrillators following the discovery of a manufacturing problem that could render the devices unable to provide life-saving electric shocks.
It's pretty amazing these long-existing medical device manufacturers keep releasing products before they're fully (creatively) tested - and the implications are severe: death.
Please feel free to read the article I posted, and tell me what you think.
Medical Device Recalls – Do You See the Pattern…?
Whenever I review the latest entries on the FDA Recall List , I’m still surprised when I see the Reason for Recall information. Especially since several device manufacturers appear on the list – repeatedly. “XYZ Medical” is recalling the “ABC” Product...
The huge advantage of a Special-type submission is that the FDA timeline for decision on your submission is 30 days instead of 90 days. However, you need to make sure that you are making a minor modification to the device. If there are multiple changes, and the changes require multiple functional specialties to review your submission, then your submission will be converted to a Traditional-type of submission and clearance will be delayed.
One strategy that has been used successfully is to submit a series of minor device modifications as a series of Special 510(k) submissions. This is especially useful for software feature additions.
However, most design processes and 510(k) templates that companies use are specific to Traditional-type 510(k) submissions. You need to modify your templates, your submission strategy and your overall design plan for a Special-type submission.
Next Thursday, March 8 @ 1pm EST, I will be hosting a webinar to show people how I modify 510(k) templates for a Special 510(k). I will also explain different strategies for Special 510(k) submissions. Finally, you will learn how to change your approach to design planning for these minor device modifications.
If you are interested in participating in the free webinar, please register on the following webpage: http://medicaldeviceacademy.com/special-510k-submission-webinar/.
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On Thursday, March 8, 2018 @ 1pm – 2pm (EST), Rob Packard is presenting a Special 510k Submission Webinar to explain how your design plan should be different for a Special 510k Submission.
With that, I would like to open up a discussion into this and see what group members, especially senior executives who have successfully navigated these waters, think. More specifically, what are the key components and actions needed to give your new medical device and start-up company the best chances of commercialization success.
If I were trying to establish a relationship with a new supplier, I might spend 15 minutes on introductions--or more. The purpose of a pre-sub meeting is to ask the FDA questions that will help you prepare your submission. You should focus as much time as possible on asking your most important questions.
Names and titles of all attendees can be communicated in advance of the meeting. Five minutes is more than enough for introductions. After introductions, you should only ask the most important questions, and you shouldn’t waste time arguing with the FDA.
The most important question is if your predicate is acceptable. If you select the wrong predicate, your entire submission may be jeopardized, or you may have to repeat comparative testing with a new predicate. The balance of your questions should focus on testing requirements. But not all tests are critical. The critical tests are the tests that take the longest, and the tests that cost the most money. If the test is quick and inexpensive, save those questions for last. You can also ask clarification questions in a supplement to the pre-submission.
You definitely should summarize action items, but this does not require 15 minutes. Typical actions items are: 1) submitting draft meeting minutes, and 2) providing additional data to the FDA in a supplement. The FDA might even be responsible for getting you additional information. Five minutes is probably all you need.
If you want to learn more about 510(k) pre-submission meetings, register for Thursday’s free webinar:
His father askes if I had any ideas - stem cell are the only thought I had or an external body robot that could be strapped on.
I wonder, do you know of any researchers who are in that area of research. If you do, I would appreciate their names so I can help him.
If any group of professionals can, I know they will be in this group who have dedicated their careers to alleviating human and animal suffering.
The FDA released two 510(k) guidance documents in 2016: 1) how to apply ISO 10993-1, and 2) applying human factors engineering. Those two guidance documents resulted in a large number of 510(k) deficiency letters. By 2017, I had completely changed my mind.
A pre-submission meeting should always be requested, even if there is a special controls guidance document. Now I start every new project with a 510(k) pre-submission request. In fact, I had three pre-submission meetings scheduled for the same week in January of this year.
On Thursday, February 22 I’m offering an updated live webinar on 510(k) pre-submissions (Free). Please visit the following webpage to register: http://medicaldeviceacademy.com/510k-pre-submission-webinar/.
In addition, we still have opening for our 2-day, 510(k) workshop in Las Vegas on March 21-22 ($995). To register, please visit the following webpage: http://medicaldeviceacademy.com/las-vegas-510k-workshop/.
Nelson Labs is offering a 1-day seminar the day before the 510(k) workshop on biocompatibility ($499): https://news.nelsonlabs.com/education/events/biocompatibility-testing-for-medical-devices-seminar.
Eisner Safety is also offering a half-day course on electrical safety ($200): https://www.eisnersafety.com/iec-60601-1-basics-workshop-las-vegas-20-mar-2018/.
Hey Joe, How's it goin'? Listen, me and the guys are gettin' together and makin' this thing. It's gonna be big. So if you know any big shots from one of your schools or businesses or anybody with a lot of money, tell them about us, okay? I'm tellin' you, you can get in on the ground floor of this thing and it's gonna be big. Call me, all right? We'll get a slice.This is no way to raise money, people. The message came from someone I hardly know who asked to connect with me here on LinkedIn. I did; he's in the industry, and we have 200 connections in common. I won't be sending him any leads. In fact, I'd delete it out of hand if it weren't so outrageous that it compelled me to stop what I was doing to write this piece. Giving him the benefit of the doubt, here's what he's saying.
Joe, you're a person of influence so I thought I'd write you. Please learn about my company, our strategy, our management, our intellectual property, our capitalization, and our likelihood of ever launching a product that will convince our target markets to switch their behaviors in favor of the behaviors that would enrich us.I suppose the next logical step would be:
I assume you know a lot of people with money. Please use your reputation and influence with them for my benefit? You might say, "Hello. It's been a while since we last spoke. Since you trust me, I'd like to tell you about someone I met. I did a deep dive into his company and while I've never spoken with him directly nor am I personally taking an equity stake, I think you should invest your money with him, or at least hear what he has to say. I wouldn't waste your time if I didn't believe in this. Good luck! And let me know what you end up doing!Sadly, that was the good scenario. The less generous interpretation is:
I'm looking for money and it would be great if you forwarded this message to anyone who might possibly invest in us.In that last one, my cash-poor friend didn't even stop long enough to consider how fast-and-loose he was playing with my reputation.
Moral of the storyDon't do that. Instead, consider what Mark Kraus, a member of the world's largest angel investor network, advised members of the Medical Devices Group back in 2015. He says: "When I am approached about a company, I generally ask for two pieces of information: • A one or two page summary of their business; and, • A short slide deck that the company uses in a 7- to 10-minute pitch for fundraising. The 1-2 page summary should include the following, each with a concise, single paragraph and/or bullet points. It's important to be concise – it's not a full business plan! Company Contact Info – name, address, url, key management, board, advisors, contact info for CEO Company Overview – elevator pitch summary of the company Market Problem – what problem / opportunity is the company trying to address? Solution – What product / service is the company developing to address that market problem? Market – Short description of overall market segment (overall size, revenue, segmentation and competition) Regulatory – What is the regulatory status or plans for the company’s product / service? Intellectual Property – Describe any patents granted, patents applied for, licenses, university/other commercialization agreements Business Model – How will your company make money? How will investors make money (exit, IPO, partnership, etc.)? Deal Terms – Prior funding summary, pre-money valuation, deal terms for current raise The slide deck needs to address the above points as well, albeit in a presentation format. Graphs, pictures, timelines, prototype examples, simple tables are often used. Generally a little more detail on financial than the above one pager allows, but important to keep it high level and not a detailed, complex spreadsheet. Overall, the presentation needs to tell a story that captures the essence of the company and why this is a great investment opportunity." Mark said if company executives can't provide the above, they probably aren't ready for his money.
For further reading, all these Medical Devices Group discussions:• Creative Funding in a Difficult Medical Device Environment http://medgroup.biz/creative-funding • How much money do you need to raise? http://bit.ly/how-much-raise • Why can't I get my start-up funded? http://bit.ly/why-not-funded • What 3 things must a startup do to get funding? http://bit.ly/get-medtech-funding • Is a prototype enough? http://bit.ly/ptotype • Medical Device Funding’s Dead Zone http://medgroup.biz/dead-zone • Got a $10-million idea? Who cares! http://bit.ly/10-mil-who-cares About the author: Joe Hage leads the world’s largest Medical Devices Group (350,000+ members), the industry’s only spam-free, curated forum for intelligent conversations with medical device thought leaders. Mr. Hage’s medical device marketing services help companies engage qualified prospects and his 10x Medical Device Conference unites Medical Devices Group members in an fun and educational forum each year.
So if anyone can suggest suitable trade shows it would be greatly appreciated or companies that we should be talking to.
• SWOT “review your QMS to improve or verify compliance.” Back in my day, we called this an internal audit. How is the intent this example different from an internal audit?
• HACCP “an area of improvement in the QMS process then triggers use of a more detailed analysis.” So in the internal audit system, deficiencies and areas of improvement are identified in an audit report. Typically, each item is investigated in an audit response that involves a root cause investigation. Sounds like a “more detailed analysis” to me.
• Project Plan “create a strong project plan for improvement to address identified weaknesses.”Again, most audit response systems I have seen involve a corrective and preventive action plan coupled with effectiveness evaluation. How is a corrective or preventive action plan different from a “strong project plan for improvement”?
I fail to see why the Guide recommends creating a multi-layered risk-based analysis system when existing, long-standing systems within the QMS could be augmented with more risk-based concepts. The last thing small manufacturers need is to reinvent the wheel when existing systems can be utilized to fulfill the intent of the new risk-based approach requirement.
My last point of contention with the example is the number of layers and tools needed to conduct a comprehensive analysis of the QMS. Lets estimate the math.
• 1 SWOT x 5 major subsystems = at least 5 SWOT
• 5 SWOTS x identified 2 areas for improvement per system = 10 HACCP’s
• 10 HACCP’s x identified 3 areas in need of a project plan = 30 project plans
That’s a minimum of 45 new documents to effectively manage. This resource-intense example isn’t practical to small and mid sized manufacturers. And what does modeling a risk of not meeting a regulatory requirement look like? https://wp.me/p6wmF6-eG
Death by Risk-based Approach: The Practical Guide to the ISO 13485:2016 Practical Guide Part 3
This is the third post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide”. (See the first installment and second installment.) This post explores examples and applicat…
In my experience, one unintended consequence is an undercapitalized startup, starved for cash and struggling to achieve milestones with inadequate resources. I own stock in one enterprise that has projected accomplishing its next important big step in six months for the last seven years. With the passage of time, the danger of another new market entrant eating their lunch grows. They could well save on their fare but miss the boat.
Other founders have told me that they loathe raising money, hustling to convince angel investors and or VCs to get attention to make a pitch, and facing serial rejections – even from people who stared at their mobile devices during the presentation. Worse yet, some potential investors do not respond definitively one way or the other. They seemed to endlessly discuss the idea with their partners, or ask for more information, or wait for another investor to move first. No wonder that so many entrepreneurs find the process highly frustrating, even when they are confident that they will eventually succeed at raising the next round.
The balance of risks is a difficult question. Whether it is more dangerous to raise money and risk control and share of the pie, or to shun new money and perhaps slow growth or even invite getting blind-sided by new competitors. Equity-stingy founders may fail to ask the question openly, or exert a genuine effort to answer it honestly, or to revisit the question at appropriate intervals. That kind of mistake could prove fatal.
How in the world can I get past the HR filtering nightmare... and how do I know If I did?
Key take-aways include:
• Justify all requirements or quality system elements deemed not appropriate with a written rationale. While a written justification is not required by the standard or Guide, having the rationale documented will help avoid discussions with an auditor debating the “appropriateness” of a particular requirement.
• Interpret “proportionate to the effects” to be synonymous with applying a risk-based approach.
• Apply a “risk-based approach” or justification to every QMS element.
Note these recommendations are based on my own conclusions after reading the ambiguous information available on risk-based approach. The take-aways are not meant to infer a requirement from the standard or guide but rather reflect my own ideas on implementation.
Take a look at the post and let me know your thoughts on risk-based approach and associated terminology.
Risk-based approach as clear as mud: The Practical Guide to the ISO 13485:2016 Practical Guide Post 2
This is the second post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide.” If you missed the first installment, catch up by reading it here. This post explores how the Pract…
When I see bad numbers staying bad I suspect systemic flaws. So, I am starting a research campaign. I will be calling a select group of 100 industry practitioners to get their take on the problem and the pains it inflicts on them and their organizations.
You can jump ahead of the line and contact me directly to contribute your thoughts. Be prepared to take a quick 5 question problem survey. You can also volunteer for a deeper interview on where the industry should head. Feel free to reply to this post. Also, get more information and be proactive on my website www.menloparkassociates.com. I look forward the conversation we can have.
Eager to know, if there exist vendors/platform to connect multiple health parameters (BP, TP, Glucose, ECG & much more) from monitoring devices of the patient.
This is basically to monitor the patients remotely.
We are not a manufacturer and there are no local regulation or obligation that sales site shall apply ISO14971 to my knowledge. But, I heard from someone that we should do. Is there anyone that in similar situation?
If sales site should adopt ISO14971, anyone can advise how to? ISO14971 is very much focused on product related risk for its lifecycle and I don't have idea how to apply the standard for commercial process independently.
Any advice or idea sharing will be appreciated!
5 Tips for Medical Device Engineers on FDA Design Controls
If you are an engineer in the medical device industry, you probably have a love/hate relationship with the FDA-mandated design controls process. While implementing design controls can feel like a majo
- The practical guide is huge…but it still doesn’t contain all the details industry needs.
- The practical guide does not differentiate between new ISO 13485:2016 and old (2003/2012) requirements
- The Practical Guide’s guidance on the risk-based approach (perhaps one of the most significant changes to the 2016 standard) is limited.
I discuss these points in detail in my latest blog. What were you expecting of the guide? What did you like or dislike? What was helpful to you?
The Practical Guide to the ISO 13485:2016 Practical Guide
Three things to consider before picking up the ISO 13485:2016 Practical Guide Manufacturers everywhere have been waiting a year and a half for additional guidance on the requirements of ISO 13485:2…
Philips Healthcare Trick or Treat
If you have not been scared enough by Halloween, read this consent decree announcement made by the FDA on November 1 to Philips Healthcare concerning quality control issues with their automatic ext…
Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices
How to implement and maintain a risk-based CAPA process while avoiding the most common pitfalls at your medical device company.
1- " shall document a procedure"
2- "shall document procedures"?
Does 1 mean that we need to implement one procedure per subject ( internal audit, control of documents..) and 2 means that we can implement the requirements (example 7.3.9 design changes ) in other procedures ?
Do you know if the FDA can inspect your emails if you used email as a record as a proof of compliance?
Joe Hage: That’s because they're doing it so quickly we can afford the extra room, right?
Terry Sweeney: Well, right now they’re fully staffed.
Joe Hage: That was a joke.
Terry Sweeney: Ha, yes. It's a question of user fees going up, if this budget proposal goes through as it is, the user fees will go up by 71 percent starting in 2018. If there's a shortfall, that’ll go up even higher.
Joe Hage: So, can I think of it as pay for service?
Terry Sweeney: Oh yes, it's a user fee, definitely.
Joe Hage: If I don't need their counsel for clearance I don't need to pay?
Terry Sweeney: You know, you don't pay unless you need a clearance, but the question is most products coming to the market do require the FDA review. Very few do not, that are exempt from that review process. PMA pre-market approval, typically our new innovation technologies, could go up to almost $500,000 per submission. To pay for the review of the submission, no guarantee you'll get it cleared. But likewise, the De Novo and further 510(k) submission cost will go up right along with that.
Joe Hage: Any idea what those are?
Terry Sweeney: De Novo could go up close to $90,000, 510(k) could be up on the order of $20,000.
Joe Hage: Sounds like a start-up will need to do a seed round.
Terry Sweeney: Start-ups should be able to get some reduction in that was based on the size of their company. FDA will cut them a break on that, but larger companies, mid-sized, companies will be looking at those fees.
Joe Hage: Do you believe that this will impact small companies, and actually hinder innovation?
Terry Sweeney: Well again the availability of the reviewers and the ability for a small company to interact with those reviewers, will be impacted negatively if that budget goes through.
Joe Hage: As a counselor to Phillips but perhaps if you were engaging for small clients, how would you help them navigate this new reality?
Terry Sweeney: Not an easy question, they definitely have to get a regulatory adviser to help them out, whether it be on staff or somebody to consult with them that is knowledgeable these new areas. It's going be a brave new world out there for them, to go through this regulatory scheme. All bets are off! Things are looking good right now in 2017, but 2018 will be totally different.
Joe Hage: Will it be less expensive to get clearances overseas?
Terry Sweeney: Yeah, but it won't help you get to the United States, which is the big market so it's the most problematic situation.
Joe Hage: Does it further the argument that it's better to innovate in Europe first?
Terry Sweeney: You still have to pay for your product clearances in Europe. The industry pays a hundred percent of those, it's just that we're not used to having to pay these high fees to the US FDA.
If you want to learn more abou the FY 2018 user fees and the strategic implications, the following blog article was posted yesterday:
Applying for small business qualification is best approach to reduce you costs of FDA regulatory submissions. If you have not completed a small business qualification form before, you can learn how to prepare your application for small business qualification by registering for a webinar this Friday, September 8, 2017:
FDA User Fee Increase for FY 2018 – Strategic Implications
This article identifies strategic implications of the FDA user fee increase for FY 2018 that was published by the FDA last week.
Trends in EU regulation of software as medical device
Presentation at the Personal Connected Health Alliance about regulatory trends in EU regulation of software as medical device
New legal obligations and liability under MDR and IVDR
Presentation at the MedTech Summit in Amsterdam on 19 June 2017 on the product liability regime under the MDR and IVDR, its nexus with the EU Product Liability Directive and its impact on other provisions in the MDR / IVDR
The following webpage provides FDA guidance on software documentation required in 510(k) submissions: https://www.fda.gov/RegulatoryInformation/Guidances/ucm089543.htm.
To determine the level of concern, you need to answer 7 questions found in the guidance document. If all 7 questions are negative, then the software is a minor level of concern by default.
It is important to read all questions and answer the questions as if you were the FDA. In many companies, the people performing risk analysis will identify risks of delay in treatment as being insignificant risks. However, the FDA typically scores the potential severity of harm much higher. Therefore, it is important to review any guidance documentation provided for your product classification to see if the FDA has already identified the level of concern for your software. If a guidance exists, but the FDA does not specify the level of concern, I recommend sending an email to the person that is responsible for the guidance at the FDA.
For minor and moderate levels of concern, the guidance indicates that less documentation for software validation needs to be submitted as part of your 510(k) submission.
The guidance DOES NOT say that you need to do less software validation or document less. The FDA allows you to submit less documentation for a 510(k), but you still have to do the same work.
A new, 2-day 510(k) workshop will be hosted in Amsterdam by Factory-CRO and my consulting firm. The dates of the workshop are October 11-12, 2017. For more information, please visit the following webpage: http://medicaldeviceacademy.com/amsterdam-510k-workshop/ .