Updates Discussion Paper - Request for Comment 3D Printing Medical Devices at the Point of Care: Discussion Paper The discussion paper provides background information on 3D printing and proposes potential PoC manufacturing scenarios for public comment. The discussion paper does not constitute guidance; instead, its purpose is to gather feedback from the public to inform future policy development. The discussion paper: - Considers relevant background, including terminology, the FDA regulation of devices and 3D printing, and how capabilities at a 3D printing facility factor into device safety and effectiveness.
- Identifies challenges presented by 3D printed medical devices at PoC and presents a potential approach for regulatory oversight under various scenarios to inform future policy development.
- Poses key questions to facilitate public comment.
The FDA is seeking input on each of these topics and on 16 questions posed in the discussion paper. Submitting Comments on the Discussion Paper As part of its commitment to innovations in device design and functions, the FDA is sharing 3D Printing Medical Devices at the Point of Care for review and comment. The FDA encourages stakeholders to provide comments. Consumer Updates Dermal Filler Do's and Don'ts for Wrinkles, Lips and More People are seeking treatments to smooth smile lines and crow's feet and plump up their lips, cheeks, and hands. Injecting dermal fillers into the face and hands can improve the appearance of facial lines and volume loss caused by age or certain medical conditions. In studies of dermal fillers approved by the U.S. Food and Drug Administration, people generally report they are satisfied with their treatment results. Know Your Treatment Options for COVID-19 Patients today have more treatment options in the battle against coronavirus disease. The U.S. Food and Drug Administration has approved one drug treatment for COVID-19 and has authorized others for emergency use during this public health emergency. In addition, many more therapies are being tested in clinical trials to evaluate whether they are safe and effective in combating COVID-19. Here's a closer look at some of the available COVID-19 treatments and how to get more information about them and others. Talk to your health care provider about available treatment options if you have COVID-19. Your provider will know the best option for you, based on your symptoms, risks, and health history. Weight Loss, Male Enhancement and Other Products Sold Online or in Stores May Be Dangerous Whether you're looking to buy weight loss, male enhancement, or certain other products, these days you're apt to look for them online, rather than at a physical store. But buyer, beware. When you buy such products, you may actually be getting an illegal product; and that product may contain potentially dangerous ingredients that are not on the label. This is not a new development. Over the past decade, the U.S. Food and Drug Administration (FDA) has frequently warned consumers that certain products sold over-the-counter (OTC)—including those sold over the "virtual" counter—contain hidden active ingredients that could be harmful. Hidden ingredients are a problem in products promoted for weight loss, body building, pain relief, sleep aids, and sexual enhancement. Often, products containing active ingredients in FDA-approved drugs are falsely represented as dietary supplements. Beware of Vaping Products with Unproven Health Claims The U.S. Food and Drug Administration wants consumers to know certain "wellness" vaping products containing vitamins and/or essential oils are being illegally sold with unproven claims and could be harmful if used. Currently, no vaping products are approved by the FDA to prevent or treat any health conditions or diseases. Some vaping products are being illegally offered for sale with unproven health or wellness claims, including improving mental clarity or treating tumors or asthma. Medical Device Cybersecurity: What You Need to Know Pacemakers, insulin pumps and other medical devices are becoming more advanced. Most contain software and connect to the internet, hospital networks, your mobile phone, or other devices to share information. Because of this, it is important to make sure medical devices are cyber secure. New technologies are being applied to all different types of devices—those that are implantable or wearable or used at home or in health care settings. The advances can offer care that is safer, more timely and more convenient. For example, patients with an implanted heart device can be monitored remotely, potentially reducing the number of visits to the doctor's office. People with diabetes have new options for managing their blood-sugar levels because some glucose meters and insulin pumps can essentially talk to each other. Hospitals aiming to improve care and efficiency are using more devices that are networked together to share data. Webinars and Virtual Workshops Conversation on Cancer: "50 Years and Counting: Engaging the Generations on Future Cancer Equity Opportunities" The FDA Oncology Center of Excellence (OCE) joins the entire cancer community in recognizing the 50th anniversary of the National Cancer Act. The Conversations on Cancer public panel discussion "50 Years and Counting: Engaging the Generations on Future Cancer Equity Opportunities" will address important cancer drug development achievements during the last five decades. The discussion will feature some of the nation's leading cancer experts focusing on the promise of cancer research and cancer equity for future generations of patients and families. December 13, 2021; 2:00 PM - 3:30 PM ET Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation The FDA hosts regular virtual Town Halls for SARS-CoV-2 test developers. The purpose of these Town Halls is to help answer technical questions about the development and validation of tests for SARS-CoV-2. December 15, 2021; 12:15 PM - 1:15 PM ET Registration is not required. OTC Monograph Reform: Deemed Final Orders This webinar will discuss: - An overview of Over-the-Counter (OTC) Monograph Reform and will highlight Deemed Final Orders (DFOs).
- Certain final administrative orders (final orders), including for OTC drug monographs, that were deemed to be final orders by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which added a new section to the Federal Food, Drug, and Cosmetic Act (FD&C Act).
- The process for making these final orders available.
- The new web portal, OTC Monographs@FDA, which:
- Provides a resource for the public to view proposed, final, and interim final orders for OTC monograph drugs.
- Facilitates the submission of comments and data from the public for proposed and interim final administrative orders, except if otherwise specified.
December 15, 2021; 1:00 PM - 2:00 PM ET OTC Monograph Reform: OTC Sunscreen Drugs On September 24, 2021, FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs. FDA posted the deemed final order (DFO) for sunscreens which sets the current requirements for marketing OTC sunscreen products. FDA also posted the proposed order for sunscreens to amend and revise this deemed final order for OTC sunscreens products. December 15, 2021; 3:00 PM - 4:00 PM ET Endpoint Considerations to Facilitate Drug Development for Niemann-Pick Type C (NPC) Public Workshop The FDA and Duke-Margolis will host a virtual public workshop on endpoint considerations to facilitate drug development for NPC. During this workshop, participants will discuss clinical endpoints relevant to NPC clinical trials and innovative strategies to support therapeutic development for patients with NPC. The workshop is open to the public and will include representation from the patient community, health care providers, industry, and other federal partners. January 24 - 25, 2022; 12:00 PM - 3:30 PM ET About Us The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations. Did someone forward you this email? Sign up below! |
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