Since 1994, under the direction of E J Smith, President, Smith Associates has specialized in regulatory services for the medical manufacturers of medical devices, in vitro diagnostics, cosmetics, biologics and blood. We have recently added Drug Monograph registration and consulting to our portfolio.
Smith Associates has extensive experience in all aspects of the regulatory processes of 510(k), 513(g), Pre-IDE, IDEs and PMA/BLA submissions. Our successes with 510(k)s, PMA, and IDEs, are summarized in our Projects.
Dealing with the Food and Drug Administration is no easy task. The Food and Drug Administration requires all medical device companies to have a comprehensive Quality System in place to ensure that the products they clear are the products being produced and shipped throughout the United States. Smith Associates can assist small and large companies in writing and implementing their Quality System, or enhancing their ISO Quality System to conformance to Part 820. Our Standard Operating Procedures, Forms and Work Instructions have been inspected many times by Food and Drug Administration Inspectors.
If you are planning on adding additional products to your existing line or are a start-up medical device company you need to be aware of 21 CFR 820.30 Design Control. The current thinking at the Food and Drug Administration is more in-depth inspections of the Design History File documentation (design inputs, design process, and design outputs), Device Master Record (DMR), Acceptance Criteria, Design Review Meeting minutes, verification and validation steps including Risk Analysis (ISO14197), Human Factor Studies, etc. Smith Associates has created a Step-by-Step Standard Operating Procedure to assist you in meeting the requirements of 21 CFR 820.30 from concept and feasibility to final finished product.
Food and Drug Administration 483 Observations are up due to the fact FDA has more Inspectors who have the time to performed in-depth inspections. Smith Associates can help you prepare for an upcoming FDA inspection by conducting a Pre-FDA Inspection audit and can assist your company in responding to any 483 Observations in a comprehensive manner. 483 Observation(s) have a very short turn-around time frame and many companies do not understand that responding to the FDA observations in less than a comprehensive manner can and will lead to a Warning Letter.
The Food and Drug Administration is now requiring all companies who have an at- home-use product to perform Human Studies to validate label comprehension and ease-of-use of the product. Smith Associates has conducted many Human Factor Studies and Simulated Clinical Use Studies over the past 5 years. We offer immediate availability to the target population and have 9 hospitals throughout the Washington/Baltimore area to assist in Simulated Clinical Use Studies.
Smith Associates has prepared dozens of IDE (clinical trials) and Clinical Administrative plans for presentation to the Food and Drug Administration. Smith Associates is contracted to handle medical device and in-vitro IDE/BLA submissions for the National Institutes of Health (NIH) National Heart, Lung, and Blood Institute, Office of Technology Transfer and Development.
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