Thank you to those who were able to attend the recent Orthopedic Intelligence webinar presented by Jeffrey D. Zigler, J.D. on The Future for Spine Reimbursement. For those who were not able to attend the webinar, please be aware that a recording of the webinar is available for viewing below.
To learn about future webinars, please visit here.
“Do any of the products that you produce or plan to market have unique design elements that you consider to be important to your product differentiation?”
This is a question posed by a new online tool released by the U.S. Patent and Trademark Office (USPTO) to “help manufacturers, small businesses, entrepreneurs and independent inventors easily assess their knowledge of intellectual property (IP).” The assessment guides you through a set of 62 questions to help you investigate your position with respect to trademarks, copyrights, design patents, trade secrets, utility patents, using technology of others, licensing technology to others, international IP rights and IP asset tracking. Upon completing the assessment, you will receive a customized set of IP strategies and best practices based on your responses.
If your answer to the question above was yes, you may benefit from obtaining a design patent. A design patent differs from its more well-known cousin the utility patent in that the design patent protects the look of a product while a utility patent protects how it is used or works. To continue reviewing your IP position, check out the full assessment for more great questions.
If this assessment raises issues that you would like to address, we at MCRA would welcome the opportunity to help. We provide high quality patent searches for medical devices and other medical technologies and are always happy to discuss your search requirements and give you a complimentary quote.
MCRA’s Senior Director of Quality Assurance, Steve Mounts, will be presenting on the topic of Regulatory Requirements and Validation at the Orthopedic Design & Technology Forum in Memphis on May 3, 2012.
Operational challenges often can lead to weaknesses and gaps in systems that deliver and sustain the validated state for devices and processes. As regulatory enforcement continues to grow, companies are discovering vulnerabilities in their validation programs that were intended to assure requirements are met and deliver safe and effective products. Steve’s presentation will help companies learn how to identify gaps in their validation program and discuss means to deliver prioritized and sustained remediation.
If you will be in attendence at the ODT Forum and interested in this topic, please be sure to attend Steve’s presentation which will take place at 11:45 am – 12:30 pm CDT.
Many individuals new to the medical device industry in the United States may be confused when they hear the acronym QSR. The Food and Drug Administration (FDA) Quality System Regulation (QSR) is based on the Federal Food, Drug and Cosmetic Act, otherwise known as The Act in our industry. The Act is contained in the United States Code (i.e., federal laws), the laws passed by the United States Congress. The QSR can be found in the Code of Federal Regulations (CFR) which is periodically updated and published by Congress. The actual location for the QSR is The Code of Federal Regulations, Title 21 – Food and Drugs, Part 820. In our industry this is commonly abbreviated by 21 CFR Part 820.
QSR is often called current good manufacturing practices and is the basis used by FDA to perform a facility inspection following the Quality System Inspection Technique (QSIT). As the name implies, QSR is the regulation for medical devices. Quoting from the regulation, “this part establishes basic requirements applicable to manufacturers ….” Manufacturers of class II and class III (and certain class I) medical devices sold in the United States are required to comply with this regulation. The regulation states it is to be applied to any finished device “manufactured, imported or offered for import ….” And most importantly the regulation has requirements “intended to ensure that finished devices will be safe and effective ….” What this means is if the medical device is to be available for sale in the United States, the manufacturer must meet the requirements in the regulation.
QSR is not a quality management system for medical devices. The well-known standard in the medical device industry for a quality management system is ISO 13485:2003 Medical devices – quality management systems – requirements for regulatory purposes. The QSR differs from ISO 13485 in many facets, including procedures, records and required investigations. When one reads through the QSR and makes a comparison with ISO 13485, you will notice a significant wording difference. The QSR states ‘the manufacturer shall establish and maintain …” versus the wording of “the organization shall …” found in ISO 13485. The QSR is a regulation and ISO 13485 is a standard.
Failure to meet the regulation is a violation and may result in a warning letter from FDA. A failure to respond to the warning letter in the mandatory fifteen (15) business days after the receipt of the warning letter will result in further consequences for the firm. A hold on the review of regulatory submissions, the refusal to allow the product into the United States, seizure, injunction, and monetary fines are some of the avenues utilized by FDA to resolve a violation. Between January 6, 2012, and April 19, 2012, FDA has issued 160 warning letters with 37 of the warning letters issued to medical device firms for violations of the QSR.
The bottom line – FDA expects compliance with the regulation.
Follow Us: