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, biologics and blood. This includes the most common route to clearance in the United States, the 510(k) submission (PMN), and also Pre Submissions, Pre-IDE, PMA, and Human Factors studies required for validation of the device by the intended use for inclusion in 510(k)s.
510(k) Pre-Submission | IDE | PMA
Smith Associates has extensive experience in all aspects of the regulatory processes of 510(k), Pre-Submissions, IDEs and PMA/BLA submissions. Our successes with 510(k)s, PMA, and IDEs, are summarized in our Projects.
Equally important to the clearance to market in the US, whether by a PMN or PMA is compliance to the Quality System requirements. The FDA expects your Quality System to be compliant to Part 820, 803 and 807 and your product developed under Design Control 820.30.
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 implemented, audited and inspected by the FDA and has successfully fulfilled the FDA’s requirements.
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.
Quality System Audits
and Preparation for FDA Inspection
E.J. Smith, President, has a long and extensive experience in auditing and preparing factories for Quality System compliance and inspections, from Class III implant factories or in vitro diagnostics facilities to the Class I two person device company. All are audited and all are required to have a Quality System in place.
Human Factors & Design Control & 510(k) Submissions
We have performed Human Factor studies by the lay user and the clinician since the very beginning of validation by the intended user. As the years have passed there is increased demand by the FDA for this type of verification in the Design Control process and 510k submissions.
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 10 years.
483 and Warning Letter Response
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.