A second look at 510(k) changes
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The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters. In general, FDA does not return filings because the change described in them is not sufficiently "significant", and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k).
Therefore, it is up to the sponsor/manufacturer to determine whether this change will be significant or not. The decision has to be made by the manufacturer, subject to review by the FDA inspector. This talk will provide quality and regulatory personnel the means to help to the company make the right decision and document it fully, before the change goes through.
Why should you Attend: Failure to file a 510(k) for a change to a product which has already been cleared under 510(k) is one of the more frequent complaints in 483's and in warning letters. The result of this finding is the requirement to file a 510(k) for a product that is on the market, and usually, to file a 510(k) and have the change cleared before the product can be marketed with the change. In general, FDA will not insist on recalling product with the change already in the market unless they decide there is a safety issue, but even so, this means disruption of the manufacturing (already producing the changed product) and marketing for the product. The best approach is to understand what FDA means by a "significant change" and document completely the reasons why you believe the change does not warrant a filing.
Areas Covered in the Session:
Who Will Benefit:
- Background: the regulation
- Guidance and FDA expectations
- Concrete examples
- Analysis (consecutive changes)and checklist
- QA and RA specialists
- QA and RA managers
Anna Longwellis currently principal attorney of the Palo Alto Law firm, Longwell and Associates, which specializes in Food and Drug law. The firm has expertise in US FDA expectations, regulation and law, affecting the development and ultimate marketing of new medical products, drugs, devices and biologics.
They have served the regulatory needs of large (>$2 billion/year) divisions of Fortune 500 companies, and small (4 person) biotech start-ups. Prior to establishing the firm, Ms. Longwell was VP of Regulatory affairs for Becton Dickinson, Medical a > $2 billion/annum unit of BD engaged in global manufacture and sale of medical devices, consumer products and OTC drugs. In that context, she participated as regulatory expert in many pre-acquisition due diligence teams.
Prior work experience included a division of BD investigating monoclonal antibodies as therapy, and Alza Corporation during the period when they pioneered combination products. She has been a visiting lecturer in food and drug law at the University of Santa Clara school of law, a visiting lecturer in food law at the Institute of Agribusiness, University of Santa Clara School of Business, a visiting lecturer in regulatory topics at the Haas School of Business, UC Berkeley, and the UC Santa Cruz Extension (UCSC), and an instructor for the Food and Drug Law Institute (FDLI) internship program at Catholic University, Washington DC.
Currently, she is co-teaching a class in US Medical Device Regulation, winter quarters at UCSC. Ms. Longwell has coauthored a book chapter titled "Due Diligence Points to Consider" in the "Expert's Guide to Healthcare Product Due Diligence" published by FDLI.
Ms. Longwell holds a bachelor's degree in Chemistry from San Francisco College for Women (now USF), a Master's degree in Physical Science from Stanford University, and a JD and MBA from The University of Santa Clara School of Law and School of Business, respectively. She is a current member of the California Bar (#166040) and the US Patent bar (#50629).