However, it does not name specific risk assessment procedures, but rather the kinds of risk assessment activities which will help a manufacturer determine whether to prepare a letter to file or 510(k) submission. You may in fact be right, that this might be the first software specific guidance, that I don't know. And now, to most people, that would seem, "Gee, what a trivial change? So Mike, welcome back to the program. (function () { But obviously, you are a guru when it comes to quality systems and design controls, have you seen anything like that in any of the company systems that you've dealt with? Legal Info, The Risk Management True Quality Summit Series is coming to your screen July 18-20, Understanding the New FDA Guidance on Changes to a 510(k), The Global Medical Device Podcast powered by. Assuming you want to keep those products on the market post-EUA, do you Why does FDA have three systems in place to address and handle risk for medical devices? But yes, really, this concept that you just described would fit into what I would refer to as product portfolio management, others look at it as product management, where you look at that product oftentimes, that's viewed as a marketing or a business activity which obviously, keeping on the straight, narrow, and on the right path from a regulatory perspective, is important. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. var zi = document.createElement('script'); Mike Drues: I don't go quite that far, but I very much understand what she means. Submitting a physical copy is now optional. id = ''; // Optional Custom ID for user in your system This may receive pushback from FDA during the RTA process, and may require additional discussion with FDA, but its worth having that conversation on your terms and timeline, rather than during an FDA inspection. Our website is made possible by displaying online advertisements to our visitors. And at the end of that process, and I've done this several times now, because the regulation does not have a formal pathway, there is no specific type of Pre-Sub meeting that you can request to notify FDA of a change like this, but the regulation does not say that you cannot do this either. Click through an interactive demo. Hello, Mr. Or Mrs FDA reviewer, come on in, have a seat, let's get a cup of coffee." gtag('js', new Date()); Yet another conversation in the future, and that is the difference between a draft versus final guidance. Provide all evidence for why the change is acceptable. The letter-to-file is usually the path that's chosen, even though there is no FDA guidance or template for an LTF that manufacturers can follow. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Join 200,000+ other medical device professionals outperforming their peers. Mike consults with FDA, he consults with Health Canada and other regulatory agencies all over the world. By the way, I'm not advocating that we create a PhD dissertation here by any means. Jon Speer: Yeah. And on today's episode of The Global Medical Device Podcast, Mike Drues and I talk about deciding what to do when you're changing a device that has received 510(k) clearance. The choice of a lawyer or other professional is an important decision and should not be based solely upon advertisements. PDF INVESTIGATIONAL PRODUCT DESTRUCTION FORM J - National Institute of Obviously, if any in your audience has specific situations, I'm happy to drill into those in much more detail, but that would be my best general advice. . Got It. Clients who would like to continue to send a physical copy to the FDA can do so by sending the letter to: Jessica Bernhardt In 2016, several instances show how serious a Refusal to File action can be for a small- to medium-size pharmaceutical company. The choice is not always clear. Modifications to a Cleared Device: Letter to File or New 510(k)? In completing the risk-based assessment, manufacturers should compare the changed device to the original device, which will usually be the device that was previously found to be substantially equivalent in their most recently cleared 510(k). Mike Drues: Well, I'm glad you like that idea Jon. Jon Speer: I have not, Mike, and I think we're still in this transition period where a lot of companies, when it comes to dealing with the agency are still very much kinda don't ask, don't tell with FDA, And I think, I'm seeing a lot of companies start to embrace, like the Pre-Sub model is a good example. No attorney-client or confidential relationship is formed by the transmission of information between you and the National Law Review website or any of the law firms, attorneys or other professionals or organizations who include content on the National Law Review website. The Letter of Authorization must be submitted on company letterhead and signed with a traditional handwritten signature. JavaScript is disabled. I see a lot of companies come to the FDA and say, "We have a quality system in place, it meets the requirements of blah, blah, blah," with all due respect, talk it's cheap. In a letter to manufacturers, Health and Human Services . Jon Speer: Right. FDA: Guidance Safety Labeling Changes - Policy & Medicine d.getElementsByTagName('head')[0].appendChild(i); If such testing produces any unexpected results, the manufacturer should re-consider the conclusion about whether a 510(k) is needed. 8. Highly Legal: Will Congress Legalize Mushrooms Before Marijuana? }("1249", document.location.href, document)); 2023 Greenlight Guru. Additionally, applications will no longer include delivery instructions or require you to upload a mailing label. Jon Speer: I know. Well, Mike, I appreciate you as always, and I enjoy this conversation that we had today and Mike Drues: Thanks Jon. (function(w,q){w['QualifiedObject']=q;w[q]=w[q]||function(){ Instructions for Completing an Investigational Product Destruction Form Any legal analysis, legislative updates or other content and links should not be construed as legal or professional advice or a substitute for such advice. This could include an intent to significantly improve clinical outcomes, to mitigate a known risk, [or] in response to adverse events. A changeintendedto significantly affect the safety or effectiveness of the device is considered to be a change that couldsignificantly affect the safety or effectiveness of the device under 21 C.F.R. If the change is not intended to significantly affect the safety or effectiveness of the device, the manufacturer should conduct a risk-based assessment of whether or not the change could significantly affect the devices safety or effectiveness, either positively or negatively. A manufacturer should consider whether a change could have unintended consequences that affect safety or device performance. Change in address on ERLM US FDA: Implications to import. Lets take a look at four costly letter to file mistakes you cant afford to make. So we should not fear the FDA. Because youre literally proving substantial equivalence to a predicate device which, in this case, is itself.The letter to file isnt some kind of dodge. Certain IHCTOA letters were publicly posted prior to the update of this website, and remain available here. FDA Form 3455 - Investigator Financial Interest Disclosure. Get a personalized demo of SMART-TRIAL by Greenlight Guru today. Short-Term, Limited Duration Insurance: How Long Is Too Long? Jon Speer: Alright. zi.type = 'text/javascript'; And as I said earlier, I don't see it that way at all. The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media. S. So have a respect for the FDA absolutely, but do not fear them. This is not simply a regulatory decision, this is a business decision that we decided that this particular change was not necessary to tell FDA or anybody else. But in any event, what you're asking is a very fundamental question, how many changes can you make in an existing medical device? Using this method for evaluating risks with a medical device change can answer some important questions, such as: What impact will this product change have? I will let the audience know that Mike and I obviously chat every so often. Jon Speer: Hello, this is Jon Speer, the founder and VP of Quality and Regulatory at greenlight.guru and welcome to The Global Medical Device Podcast. Mike Drues: It's funny you mentioned that Jon, I'll give you one example where I have actually created a way to do exactly this. The final guidances explain that a new risk is a new hazard or hazardous situation that did not exist for the original device. Dear Manufacturer Letter Regarding Changes to Process Filings i = document.createElement('script'); Ready to learn more? })(); Deciding whether to submit a new 510(k) for a device modification is a significant and sometimes difficult issue for device manufacturers, which can have regulatory consequences if a decision to take the letter-to-file approach is challenged by FDA. Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Before sharing sensitive information, make sure you're on a federal government site. FDA Applications - 12 Free Templates in PDF, Word, Excel Download Mike Drues: The important thing for your audience to understand, and this is at least my approach, is that the information that goes into either of those approaches, whether it's letter to file or Special 510(k) or PMA supplement, the information is exactly the same. Thefirst guidanceprovides recommendations on medical device changes and modifications generally, while thesecond guidancefocuses specifically on software changes and modifications. DHF Template - Format and Content of Design History File The Wash Sales Rule and How Cryptocurrencies are Categorized. Institutional Data. A Warning Letter is the agency's principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act (the Act)." Consistent with Chapter 4-1-13 of the RPM on . Official FDA applications and submissions forms. I'll give you a very quick example. And regrettably, I see a lot of companies get in trouble, and by the way, in situations, it doesn't happen often, but sometimes, when companies screw this up, they find themselves not just dealing with the FDA, but also dealing with the FBI. Form FDA 0766 - Application for Authorization to Relabel or to Perform Action. Letter-to-File 101: Are You Sure You're Preparing Yours Correctly? Electronic Regulatory Submission and Review. In assessing whether a new 510(k) is required when these techniques are used, the final guidance states that in addition to considering thecomplexityof the change, manufacturers should also consider the changesimpact on risk controls or performance. ISO 13485:2016 - Medical Device Quality Management Systems, Time for a Special 510k? I get calls from companies frequently, they followed everything in a final guidance and yet they're still having problems, and I often say to them, "Well, why would you assume that final means final?" A Regulatory Perspective: FDA Final Guidance for Design Changes I think that obviously, that's just good sound engineering practices as we've talked about. Get a personalized demo of SMART-TRIAL by Greenlight Guru today. gd.src = '//j.6sc.co/6si.min.js'; Mike Drues: Yes Jon, FDA has put out a number of guidances in this topic over the years, but two most recent that you're referring to came out just on August 8, as a matter of fact. CDRH Finalizes Two Points The site is secure. And quite frankly, if I can go just a tiny bit further, the reason why this is so important to our audience Jon, is because what I really want to avoid is a scenario as follows, you make a change to your device at some months in the future, a knock comes on your door, it's the FDA, they say, "Hey, we notice that you've changed your device. i.type = 'application/javascript'; Is it possible to change IFU only for China? (CNN) - Updated COVID-19 shots should be ready by the end of September. FDA regulatory forms and application information, Official FDA applications and submissions forms, Information about review and electronic submission of regulatory information, An official website of the United States government, : Export documents for human medical device products that CDRH regulates will be issued electronically as downloadable PDFs through the CDRH Export Certification Application and Tracking System (CECATS). The .gov means its official.Federal government websites often end in .gov or .mil. function gtag(){dataLayer.push(arguments);} So the premise here is that I have a device, whether mechanical, hardware, software, it doesn't matter, but a device that has received 510(k) clearance and now I'm making a change, it's gonna happen, every single medical device is gonna have a change, it's somewhere along the way in it's life cycle. Metallic Make Up for Orthopedic Materials, Infection Control Strategies Offer a Plan of Pathogen Attack, Multi-Dimensional Approaches to Orthopedic Implant Manufacturing, Fitting the Mold of Ortho Device Manufacturing, restor3ds All-Metal PSI to Boost Growth in Ankle Replacement Market, Osteotec Opens New Offices in Ireland & Sweden, Himed & Lithoz Enter Long-Term Strategic Materials Research Partnership Agreement, AAOS Releases New Appropriate Use Criteria, AlloSource's AceConnex Pre-Sutured Fascia for Hips Earns FDA Nod, Stryker Rolls Out Q Guidance System with Cranial Guidance Software, Meeting the Challenges of the Medical Device Industry with Compact Manufacturing Innovation, Managing Risk in the Age of Rising Orthopedic Automation, Deep Diving into AI Assistance for X-Ray Diagnosis, Envisioning Access Pioneers Technological Breakthroughs for People with Physical Disabilities, Smith+Nephew Implements High-Tech Surface Finishing for Orthopedic Implants, Linda Braddon, Ph.D., President and CEO, Secure BioMed Evaluations, Technology, Engineering, or Performance Change, Evolution Devices Launches EvoWalk Platform Pilot Program, Kleiner Device Labs KG2 Surge Flow-Thru Interbody System Cleared by FDA, Exactech's Equinoxe Stemless Shoulder Replacement Debuts in Europe, HD Lifesciences Changes Name to NanoHive Medical, Accelus Introduces TiHawk9 Expandable Interbody Cage, Orthofix Launches Magnesium-Based Settable Bone Void Filler, Precision Coating Merges with N2 Biomedical, IncludeHealth Launches Proprietary Musculoskeletal Operating System with Google and ProMedica, Spinal Elements Rolls Out Luna XD and Orbit Systems, Stryker Releases Citrelock Tendon Fixation Device System, Bone Cancer: The Global Burden and Medtech Opportunity, The Impact of Bioresorbables in OrthopedicsAn Orthopedic Innovators Q&A, Powering the Wearable Orthopedic Devices of the Future, NuVasive Appoints Chief Commercial Officer and Chief Technology Officer. Note to File Examples - Research - Washington University in St. Louis Another option would be to wait for a significant change that requires a Special 510(k) submission, and include all the changes for full disclosure. More than a Quality Management System: Tools for the entire MedTech Lifecycle. A letter to file (LTF) is reserved for design changes that do not need a new regulatory submission. The part that I love about the guidance document, there's all the descriptive part, the words that go along with it, but the parts that I really enjoy are the decision tree flowcharts that are included. One thing I wanna clarify on the onset is, these two new documents, they are currently draft guidances. Mike Drues: You're exactly right, 1997. The first called, deciding when to submit a 510(k) for a change, to an existing medical device, and the second, deciding when to submit a 510(k) for a software change to an existing medical device. Experience the #1 QMS software for medical device companies first-hand. Looking for a design control solution to help you bring safer medical devices to market faster with less risk? Looking for a design control solution to help you bring safer medical devices to market faster with less risk? Dear Medical Device Manufacturer: The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH . Re: Authorization Letter. Because in my case, most of the companies that I work with at least before they start working with me, I've never seen any kind of a requirement in there were after X number of letter to files, you need to look at the changes in the aggregate to do an evaluation. Annual Report Template. '&l='+l:'';j.async=true;j.src= I don't wanna be in a situation where you sit, where we have to say "Oh, gee, we forgot," or worse, "Oh, you caught us." Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. The FECV will be accessed using the URL address or QR code displayed at the bottom of each certificate. const cpTenantDomain = "greenlight"; Jon Speer: Right. window.dataLayer = window.dataLayer || []; 3WFN, Room 7C34. I wanna be able to say, "Oh, welcome. Do you want to improve your bone health? Building off of those general questions, there are three main areas that must be addressed when preparing your letter to file: Description of the change. So, I'm not saying, "Don't follow the flowcharts, don't follow the regulation," I'm just simply saying use that as a starting point, but at the end of the day, it's not a substitute for good engineering logic or regulatory logic or whatever you want to call it. Appendix K: Sample Authorization Letter | FDA any copies of destruction certificates or memos must be kept in the pharmacy files and a copy sent to the PM within 21 days of destruction. However, there are ways to improve this informal system. window._6si.push(['setEndpoint', 'b.6sc.co']); The guidance specific to software changes applies to software that is embedded within or a component of a medical device, that is an accessory to another medical device, or that is intended to be used for one or more medical purposes that performs these purposes without being part of a hardware medical device. Deciding When to Submit a 510(k) for a Change to an Existing Device, Deciding When to Submit a 510(k) for a Software Change to an Existing Device, All regulations in general should be thought of as a work in progress, Sometimes when companies screw this up, they find themselves dealing with the FDA and the FBI, Have a respect for the FDA, but do not fear them.. So, I think if we include that, look at how is this product doing, and we bring in the performance history from a complaint standpoint or from a customer feedback standpoint, and just use that opportunity to evaluate all the changes that we made, I think that could be a good vehicle. On October 25, 2017, FDAs Center for Devices and Radiological Health (CDRH) issued two final guidance documents that provide FDAs current thinking regarding whether a modification to a 510(k)-cleared device will require the submission of a new 510(k), or may be documented in a letter to file as part of the manufacturers quality system. (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start': In both final guidances, CDRH provides manufacturers ten guiding principles to bear in mind when analyzing device or software modifications or changes. Why would we have to do any paperwork? Imagine a supplier changes the color of a device part, or a different kind of screw is used for assembly. Visit their website to. What should it contain? Womble Continues West Coast Expansion, Combines With Southern California Governor Newsom Signs Legislation Intended to Facilitate What Does Affirmative Actions Death Knell Mean for Employers? (Prior notice is discussed in Chapter 10 of the Regulatory Procedures Manual. Mike Drues: Well, that's very unfortunate. Episode 7: Data Privacy Deadline for Colorado and Connecticut [ CFPB Teams with HHS and Treasury to Examine Medical Financial Products. Why? Attorney Advertising Notice: Prior results do not guarantee a similar outcome. All rights reserved. var gd = document.createElement('script'); There's just one last thing I'd like to share with your audience, very, very quickly, along the lines of what you said at the end there, don't fear the FDA. Well, Mike, see, we're mid-late August, and I think it was just a couple of weeks ago, maybe that even, that FDA came out with new draft guides documents on this topic of changes to a device that has 510(k) clearance, I'm sure you read those right away. Some device changes may appear so minuscule that it seems anything more than a letter to file would be a waste of FDA's time. CDRH generally posts these letters to ensure widest distribution of messaging. Medical device manufacturers make changes to existing products all the time. The key thing is to have an actual documented "letter to file" that you can retrieve, and that you can present and that you can show. Center for Devices and Radiological Health Such changes in design or manufacturing are very common in the industry, so its important to understand the regulations as it pertains to your device. Maybe each of these changes are small enough that you can handle them individually as a letter to file, but eventually, you're gonna come to a point obviously, when all those changes add up to become quite significant, where you would have to notify FDA perhaps as a Special 510(k), or maybe even it would create an entirely new medical device. It's as important as other aspects of managing a particular product. Critically, if the manufacturer has previously made changes to the device without submitting a new 510(k), they still must compare the changes being considered to the original device.