Smith Associates

Smith Associates is an FDA regulatory consulting firm founded in 1994 under the direction of President E.J. Smith. The firm specializes in assisting medical device, in vitro diagnostics, biologics, and blood product manufacturers navigate FDA compliance requirements. Located in Crofton, Maryland—approximately 20 minutes from FDA headquarters—the company maintains close proximity to the FDA Document Center for hand-delivering submissions and responses.

The firm offers comprehensive regulatory services including 510(k) submissions, pre-submissions, IDE applications, PMA/BLA submissions, human factors studies, quality system compliance, and US Agent services for foreign manufacturers. Smith Associates has completed over 280 successful 510(k) clearances across all CDRH reviewing branches. The company operates on a fixed-fee pricing model with 50% payment upfront and 50% due before submission, eliminating surprise costs during the regulatory process.

With over 100 combined years of FDA regulatory and business experience among its consultants, Smith Associates serves both domestic and international medical device companies. The firm offers free product classification services to help potential clients understand regulatory requirements before engagement.

Consider Smith Associates when geographic proximity to FDA headquarters provides strategic value for your submission timeline, particularly for devices requiring interactive review with tight response windows. The fixed-fee model suits companies with defined budgets seeking cost certainty throughout the 510(k) process.

The firm's experience across multiple device classifications and extensive international client roster makes them appropriate for both domestic manufacturers and foreign companies requiring US Agent representation alongside regulatory submission services.

Smith Associates exclusively serves the medical device regulatory sector, focusing on FDA compliance for manufacturers of medical devices, in vitro diagnostics, biologics, and blood products. The firm addresses the full spectrum of FDA submission pathways including 510(k), IDE, and PMA routes to market clearance.

Beyond submissions, the company provides quality system compliance services under 21 CFR Part 820, including SOP development, quality system audits, 483 observation responses, and recall management. Their US Agent services specifically address requirements for foreign establishments under CFR 807.40(b), including complaint handling and electronic MDR (Medical Device Reporting) submissions required as of August 2015.

Medical device manufacturers pursuing 510(k) clearance who value local FDA presence and require predictable consulting costs. Foreign manufacturers needing combined US Agent services and regulatory submission support. Companies with devices requiring rapid turnaround on FDA questions during active review periods, or those seeking consultants with business ownership perspective alongside regulatory expertise.