The Pre-Submission is becoming an increasingly popular means to approach the FDA for assistance with various questions which a potential 510k, IDE or PMA submitter may have. In this more informal setting, the FDA has greater flexibility in answering your questions. Most testing performed for the 510(k) submission is based on FDA recognized standards. What do you do if the protocols for your test or study is outside of FDA’s recognized standard? Smith Associates will submit a Pre-Submission to the FDA, for a modest fee, to seek FDA’s input concerning your protocol or other questions you may have concerning your upcoming 510(k)/PMA submission. Bench Test Protocols Mechanical studies Biocompatibility Required testing clarification Draft clinical or draft Human Factor studies, etc. The Pre-Submission review is non-binding for both parties but will provide you with sufficient information to make an informed business decision concerning your route to approval, and may save your company’s investing capital from being spent on incorrect testing or clinical studies with less than beneficial outcomes. ABOUT US 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. QUICK LINKS Home Regulatory Services Quality System Human Factor Studies Our Projects Our Clients Contact Us COMPANY INFO Smith Associates P.O. Box 4341 Crofton, MD 21114 United States Local: (410) 451-0639 Fax: (410) 793-0448 Toll Free: (888) 729-9674 Copyright 2021 GLOCOM | All Rights Reserved | Powered by NWOL | English

fda22 About fda22 This author has not yet filled in any details. So far fda22 has created 0 blog entries. Search for: Recent Comments Archives Categories No categories Meta Log in Entries feed Comments feed WordPress.org Search for: Popular Recent Comments No posts have been published yet. Meta Log in Entries feed Comments feed WordPress.org Smith Associates P.O. Box 4341 Crofton, MD 21114 United States Local: (410) 451-0639 Fax: (410) 793-0448 Toll Free: (888) 729-9674 Copyright 2021 GLOCOM | All Rights Reserved | Powered by NWOL | English