Fenwick & West’s Post

"𝘚𝘰 𝘐 𝘫𝘶𝘴𝘵 𝘸𝘢𝘯𝘵 𝘵𝘰 𝘮𝘢𝘬𝘦 𝘴𝘶𝘳𝘦 𝘮𝘺 𝘶𝘯𝘥𝘦𝘳𝘴𝘵𝘢𝘯𝘥𝘪𝘯𝘨 𝘪𝘴 𝘤𝘰𝘳𝘳𝘦𝘤𝘵. 𝘚𝘰 𝘵𝘩𝘦 𝘤𝘭𝘢𝘴𝘴 𝘰𝘧 𝘵𝘩𝘦 𝘥𝘦𝘷𝘪𝘤𝘦 𝘪𝘴 𝘯𝘰𝘵 𝘤𝘰𝘳𝘳𝘦𝘭𝘢𝘵𝘪𝘷𝘦 𝘸𝘪𝘵𝘩 𝘵𝘩𝘦 𝘵𝘺𝘱𝘦 𝘰𝘧 𝘴𝘶𝘣𝘮𝘪𝘴𝘴𝘪𝘰𝘯 𝘵𝘩𝘢𝘵 𝘺𝘰𝘶 𝘩𝘢𝘷𝘦 𝘵𝘰 𝘥𝘰. 𝘍𝘰𝘳 𝘦𝘹𝘢𝘮𝘱𝘭𝘦, 𝘪𝘧 𝘦𝘷𝘦𝘯 𝘪𝘧 𝘺𝘰𝘶 𝘩𝘢𝘷𝘦 𝘢 𝘤𝘭𝘢𝘴𝘴 𝘵𝘩𝘳𝘦𝘦 𝘥𝘦𝘷𝘪𝘤𝘦, 𝘪𝘧 𝘺𝘰𝘶 𝘣𝘦𝘭𝘪𝘦𝘷𝘦 𝘵𝘩𝘢𝘵 𝘵𝘩𝘦𝘳𝘦'𝘴 𝘢 𝘳𝘦𝘢𝘴𝘰𝘯𝘢𝘣𝘭𝘦 𝘮𝘦𝘥𝘪𝘤𝘢𝘭 𝘱𝘳𝘦𝘥𝘪𝘤𝘢𝘵𝘦, 𝘵𝘩𝘦𝘯 𝘺𝘰𝘶 𝘤𝘢𝘯, 𝘺𝘰𝘶 𝘬𝘯𝘰𝘸, 𝘴𝘶𝘣𝘮𝘪𝘵 𝘵𝘩𝘢𝘵 𝘤𝘭𝘢𝘴𝘴 𝘵𝘩𝘳𝘦𝘦 𝘥𝘦𝘷𝘪𝘤𝘦 𝘸𝘪𝘵𝘩 𝘢 510𝘬, 𝘪𝘴 𝘵𝘩𝘢𝘵 𝘤𝘰𝘳𝘳𝘦𝘤𝘵, 𝘳𝘪𝘨𝘩𝘵?" No - the class III device will specify that it requires a PMA. The product code is going to specify both the classification of your device and your submission type, and 98-99% of the time, it will specify a PMA. One of the things in 21st Century Cures Act required FDA to make an effort to remove some of the misalignment in product codes and submission types. There used to be about 14 Class III product codes that required a 510k instead of a PMA, and they removed all of those, either up-classifying them to require a PMA or down-classifying them to a 510k. "𝘖𝘬𝘢𝘺, 𝘴𝘰 𝘪𝘯 𝘵𝘩𝘪𝘴 𝘴𝘪𝘵𝘶𝘢𝘵𝘪𝘰𝘯, 𝘪𝘧 𝘢 𝘮𝘢𝘯𝘶𝘧𝘢𝘤𝘵𝘶𝘳𝘦𝘳 𝘮𝘢𝘬𝘦𝘴 𝘢 𝘯𝘦𝘸 𝘢𝘰𝘳𝘵𝘪𝘤 𝘷𝘢𝘭𝘷𝘦 𝘱𝘳𝘰𝘴𝘵𝘩𝘦𝘴𝘪𝘴 𝘵𝘩𝘢𝘵'𝘴 𝘴𝘪𝘮𝘪𝘭𝘢𝘳 𝘪𝘯 𝘢 𝘭𝘰𝘵 𝘰𝘧 𝘸𝘢𝘺𝘴 𝘵𝘰 𝘵𝘩𝘦 𝘱𝘳𝘦𝘷𝘪𝘰𝘶𝘴 𝘢𝘰𝘳𝘵𝘪𝘤 𝘷𝘢𝘭𝘷𝘦 𝘱𝘳𝘰𝘴𝘵𝘩𝘦𝘴𝘪𝘴 𝘵𝘩𝘢𝘵 𝘩𝘢𝘴 𝘢 𝘗𝘔𝘈 𝘵𝘩𝘢𝘵 𝘵𝘩𝘦𝘺'𝘷𝘦 𝘱𝘶𝘵 𝘰𝘯 𝘵𝘩𝘦 𝘮𝘢𝘳𝘬𝘦𝘵, 𝘥𝘰 𝘵𝘩𝘦𝘺 𝘩𝘢𝘷𝘦 𝘵𝘰 𝘥𝘰 𝘢 𝘣𝘳𝘢𝘯𝘥-𝘯𝘦𝘸 𝘗𝘔𝘈, 𝘧𝘰𝘳 𝘵𝘩𝘦 𝘯𝘦𝘸 𝘷𝘢𝘭𝘷𝘦 𝘮𝘢𝘵𝘦𝘳𝘪𝘢𝘭?" They have to either do a brand new one, or see if it meets the the requirements for a supplement to that original PMA. It is possible that - for some reason - the FDA down-classified aortic valves. If they did, that would be the only situation where you wouldn't need to do a PMA, so always double-check the product code database to see what the requirements are. Check out the full presentation 𝘔𝘦𝘥𝘪𝘤𝘢𝘭 𝘋𝘦𝘷𝘪𝘤𝘦𝘴 101: 𝘈𝘯 𝘌𝘯𝘵𝘳𝘺-𝘓𝘦𝘷𝘦𝘭 𝘖𝘷𝘦𝘳𝘷𝘪𝘦𝘸 𝘵𝘰 𝘵𝘩𝘦 𝘍𝘋𝘈: https://lnkd.in/dM8KB6g3 #medicaldevices #regulatoryaffairs #FDA #submissions #510k #compliance #startup #medtech #biotech #qualitymanagement

Medical Device Legal News, a video series from McGuireWoods partner Sam Bernstein, covers recent compliance and legal developments of interest to #medicaldevice companies. In this episode, Sam discusses a regulatory affairs specialist who forged false letters purporting to show the #FDA had granted clearance to sell two different medical devices; a warning letter issued to a #dialysis machine manufacturer regarding its failure to submit a 510(k) or PMA addressing the addition of water filtration components to its product; and cases involving durable medical equipment and related telemarketing #fraud, among other topics. https://lnkd.in/gffwjkPi #compliance #kickback #DME #nephrology

Many people confuse between the Sterile and non-pyrogenic symbols on medical packaging. Let's clear up the confusion: ⚪ Sterile: This symbol indicates that the product has undergone a process to eliminate all viable microorganisms, ensuring it's free from bacteria, viruses, and fungi. It's crucial for medical devices, pharmaceuticals, and other healthcare products to be sterile to prevent infections and ensure patient safety. 🔥 Non-Pyrogenic: This symbol signifies that the product is free from fever-causing agents known as pyrogens. Pyrogens can trigger immune responses and lead to fever, making it essential for injectable medications, IV fluids, and other pharmaceuticals to be free from these contaminants. 👇🏻Check out the below post to know more about the "Sterilized using Irradiation" symbol. #Sterile #NonPyrogenic #HealthcareQuality #MedicalPackaging #PatientSafety

📣 News about labeling considerations for devices containing lubricious coatings used in the vasculature. 👉 The purpose of this post is to provide the medical devices industries recommendations for information to be included in the device labeling, as submitted in premarket applications (PMAs) or premarket notification submissions (510(k)s) for Class III and Class II devices, to enhance the consistency of coating-related information across these product areas, as well as to promote the safe use of these devices in the clinical setting. 👨⚕️ Since these recommendations are based on known safety issues, FDA recommends that this information be considered for inclusion as current product labeling is updated, and that labeling included as part of future premarket submissions for intravascular devices with lubricious coatings incorporate the recommendations. Consult now and get personalized advice from the experts: 🌐 www.igaviascience.com #FDA #regulations #medicaldevicesafety #medicaldevices #guide #FDAapprovedProduct #catheters #igavia #industries #MedicalIndustries #fdanews

The “Sterilized using irradiation” symbol indicates that the medical device has been subjected to a sterilization method involving ionizing radiation. 👇Check out the post below to know more.   RegTrac offers Labelling and Artwork services to the Medical Device manufacturers. Reach out to us at sales@reg-trac.com | www.reg-trac.com. #RegTrac #eu #uk #products #regulatoryaffairs #labelling #artwork #labels #packaging #healthcare #symbols #FDA #europe #safety #regulatorycompliance #products #insert #medicaldevices #devices #identification #manufacturing #caution #precautions #sterile #sterileprocessing #sterilization #sterility #radiation

Inviting the #FDA smackdown? Case Study – Consumer Product or Medical Device It’s common for early-stage companies to take the path of least regulatory resistance. Sometimes that means avoiding FDA all together.   Here’s an example..   Compression Socks – consumer product or medical device?   Well, it depends what you say..   If you say: > “Provides compression on ankles..” > “Provides lower leg protection..” > “Improves lower leg comfort..”   Those things are not medical claims. Perfectly safe to say in marketing..   But do they compel adoption? Probably not..   Here’s what this company says on its website: > "Provides instant relief from chronic neuropathy pain" > "Improves blood circulation" > "Heals damaged tissues" > "Nerve Damage Reversing" I perused this company's website and couldn't find anything related to medical device status. Moreover, I searched Devices@FDA and 510k database -- couldn't find any filings from this company (or the Hong Kong based holding co).. So, my guess is that they are taking the consumer route and hoping to avoid FDA scrutiny.. (Could be wrong though.)   The regulatory bar for compression stockings is fairly low:   Class II, 510K Exempt, FDA Code DWL: "A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg." (Curious about this carve-out: ".. other than prevention of pooling of blood in the leg." Any #regulatory wisdom on why this is excluded?) Even if the company took this Class II route, it’s not able to say whatever it wants in promotional materials.   These claims need to be backed by clinical data with a study design and clear endpoints that are negotiated with FDA.   Without those things, this company may be awaiting an FDA smackdown. Ulrich, Kristen - What's your take? #medtech #medicaldevices #consumerproducts

The FDA has just released final guidance on remanufacturing medical devices, bringing clarity and detailed regulatory requirements into the spotlight. This long-awaited update is meticulously crafted to delineate the boundary between servicing and remanufacturing, guaranteeing top-notch safety and performance levels are maintained. Whether you're an original equipment manufacturer or a service provider, this guidance sheds light on the rules that keep our medical devices at their best. #FDA #MedicalDevices #Remanufacturing

Did you know, as many as 4,500 drugs and medical devices are recalled in the U.S. each year over safety concerns? Patients and providers relying on these products are often unaware that there is a recall, let alone what to do about it. I was honored to speak today at an FDA listening session about modernizing the U.S. recall system - a system designed to protect consumers from tainted products and save lives. No patient should be harmed or die because of a (predictable and all-too-common!) break-down in vital recall information.

Continuing our discussion last week on the FDA's new guidance for 506J FD&C Act in November of 2023. (Click to read below) https://lnkd.in/e_3hKRWi How do you think this will impact the efficiency of Medical Device companies? Let's discuss in the comments below. #MedTech #MedDevice #FDAGuidance #IndustryInsights #RA

RED FLAGS. 🚩 ⚠️ MEDICAL DEVICES REGULATORY DELAYING TACTICS Update Glossary : Notified Bodies : PRIVATE, LIMITED LIABILITY COMPANIES with Public Duties TÜVrheinland : NEGLIENT PRIVATE LIMITED LIABILITY company & notified body #PIPimplants #PIPcrimes EUROPEAN COMMISSION : opaque, unaccountable Industry Lobby group PIP Implants : Toxic, carcinogenic, immunogenic, teratogenic chemical cocktail used in the manufacture of PIP Breast implants by former chemical company salesman. On the global market and implanted into 100,000s of women worldwide. Deaths and serious injuries HIDDEN by commerical secrecy clauses in medical devices regulations. Commercial Secrecy : Medical devices Regulations are LOADED with commercial secrecy clauses and exemptions from chemical exposure legislation and labelling. CE : Criminal Endangerment Medical Devices Crimes : disproportionately impact on the health and lives of women and children IMPLANT files : international investigative journalists expose of medical devices industry RAPS REPORT 👇 “The European Commission’s Medical Device Coordination Group (MDCG) is telling medtech manufacturers to get certified under the new device and diagnostics regulations as soon as possible, in what is possibly the strongest warning to the industry yet.“