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
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.