• 3D: Printed Products: What FDA expects you to know +

    3D Printed Products: What FDA expects you to know The regulatory classification of your device will most likely be the same regardless of the manufacturing methods, but for 3D printed products (additive manufacturing) FDA stresses the importance of Design Control and therefore, design validation. Some companies who have a Class I device may consider that the quality system regs (21 CFR 820) don’t apply to them but many Class I devices are not “GMP-exempt”. And although Design Controls do not apply to Class I devices, process validation certainly still may [ref 21 CFR 820.70 and .75]. We recommend the use Read More
  • Additive 3D Printing we wrote the book... +

    Paladin Medical® wrote the book on 3D printed medical devices. Well, not the book exactly, but the first 510(k) for a 3D-printed medical device. Paladin Medical secured the Stratasys FDM MedModeler 510(k) #971290 as a radiological accessory. Medical devices produced by 3D (additive) Manufacturing are the next big thing. But the US FDA issued a guidance on December 5, 2017: Technical Considerations for Additive Manufactured Medical Devices; and they have a lot to say. If you are considering employing 3D manufacturing in any capacity for a medical device, including making changes to an existing device for which you might already Read More
  • MEDICAL DEVICE STANDARDS- Can we shed a little light? +

    Sometimes identifying the standards that apply to your medical device can seem like looking down a dark tunnel. Is that a light at the end, or a train coming towards you? It could be both! Long ago and far away, clearance of a US device with FDA did not depend upon conformity to a standard. FDA, believe it or not, didn’t recognize “voluntary” standards and according to regulation, only FDA could issue a “performance” standard. Some years back, the ice broke and certain standards for evaluation of a device became “recognized”. One of the earliest was for the evaluation for Read More
  • The Basics Of UDI’s: Important Information For Medical Device Companies To Know +

    As with every industry, the only constants in the healthcare industry are change and change. Rising costs, new regulations and more continually offer a new take on the industry. One of these new changes brought upon by the FDA is unique device identification or UDI. The Basics & The Differences Of Unique Device IdentificationThe FDA has created UDIs in an attempt to adequately identify medical devices through the lifetime of the device, whether in distribution or use. The unique device identification system will be phased in over the course of many years. Once completed, the program will offer many benefits to Read More
  • Say Goodbye To Bias: Women In Engineering Are Here To Stay +

    Paladin Medical prides itself on being an organization with a talented and diverse group of individuals striving to make a difference. This starts at the top – as president of Paladin Medical, Elaine Duncan is focused on making a difference. She strives to do so by utilizing diversity. Appointed to the sub-committee on diversity at the University of Kentucky College of Engineering Dean’s Advisory Committee, Duncan is attempting to help the college deal with a number of problems involving diversity, mainly enrollment and retention issues for females and minorities. A Bigger Problem University of Kentucky is certainly not the only school Read More
  • Transfer a 510(k)? +

    Medical device manufacturers frequently acquire by merger and acquisition a 510(k) from a previous company. The FDA draft guidance issued December 22, 2014 provides information on how to notify FDA of such transfers. http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm427385.pdf This is the FDA’s current thinking on this perplexing issue. The recipient of the 510(k) assumes the responsibility to verify when a 510(k) changes hands that there has been no significant change of the device since the original 510(k) or when the device was most recently cleared by the FDA. The validity of the 510(k) becomes the responsibility of the purchaser once the sale or acquisition Read More
  • Good Laboratory Practice Q&A +

    FDA frequently issues guidance documents in the form of Questions and Answers. The August 28, 2013 draft is still lingering on the FDA website pending comments. But with the FDA’s Refuse to File Checklist, some companies may be in for a shock if preclinical studies are submitted without a statement of compliance to Good Laboratory Practices. For many years, device studies have been informally allowed to skim GLP regulations but future studies may be in peril if the sponsors don’t appreciate the risks involved in failure to demonstrate GLP compliance. The Good Laboratory Practice for Nonclinical Laboratory Studies Regulations, 21 Read More
  • Device Master File (MAF) +

    DEVICE MASTER FILE (MAF) Companies that sell materials, components or manufacturing services should consider the benefits of a DEVICE MASTER FILE (MAF) with the Center for Devices and Radiological Health (CDRH). A MASTER FILE is a service for your customers but also helps you to maintain control on your company’s proprietary information. Consider the content of a Device Master File, how it is used by the FDA and your customers, and how it provides a shield around your company’s intellectual property, while providing the quality information your customer needs for their medical device application. Originally conceived as a means for Read More
  • Run the FDA RTA & e-COPY 510(k) Gauntlet +

    Filing a 510(k) according to the current FDA “refuse to accept” policy can be challenging. The former checklist of a few pages is now more than 26 pages for a traditional 510(k). The new policy is supposed to help FDA focus its resources on those submissions which are complete. Unfortunately some of the quirks of the checklist and the UBER-interpretations of guidance documents and regulations have caught some folks with one or more recycles of their 510(k) submission. At Paladin Medical, Inc. we have the experience to help you avoid the recycling syndrome by working with you early to plan Read More
  • 510(k) Review Process Detailed by FDA +

    FDA has updated the explanation of how the Agency will process the review of a 510(k). The most important improvement on the webpage is a color coded chart which provides a time line for each major phase of review. New in 2013, FDA added the “pre-review” step known as “Refuse to Accept” (RTA). This first review follows a very detailed checklist based upon the type of submission. The trip wire in this new review process is the way FDA reviews submissions against any guidance documents and refuses to accept any submission that fails to address ANY item in the guidance Read More
  • QUALITY 101 a Hit +

    Elaine Duncan’s presentation to the LifeScience Alley REGULATORY 101 course was a hit with the attendees. It didn’t hurt that each attendee received a free mini-regulatory booklet which contains the regulations for PART 11, GLP regulations, IDE regulations and QSRs all in one collection. The talk demonstrated how the Quality System Regulations are a SYSTEM, interlocking the parts to provide a network of documentation of the quality efforts. Comparisons between ISO 13485:2003 and Part 820 were intended to help the audience understand where key differences could lead to difficulties with FDA inspection if they are not addressed. The presentation is Read More
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