Smith Associates
Paving the Way to FDA Clearance

The FDA Quality System for Medical Devices is regulated under Part 820 of the Codes of Federal Regulations. These regulations recommend the documentation that will be needed when the FDA Investigator audits your quality system in areas such as design control, manufacturing, labeling, packaging, storage, installation, design, and servicing of all finished medical devices predetermined for human use and marketing in the U.S. They enable the manufacturers and specification developers to function normally while staying compliant with every code and its subpart.

Larger medical device corporations have trained in-house regulatory departments to assure the top management that all the Codes of Federal Regulations are met. Small start-ups and manufacturing businesses, on the other hand, struggle to stay compliant and operational due to the high overhead costs associated with writing and receiving FDA clearances and approvals and the postproduction compliance to codes of federal Regulation. Smith Associates’ mission statement is to provide comprehensive medical device consulting at a reasonable cost which is why we have fixed fee for most of our services. A small company needs a fixed budget.

Since 1994 our clients’ needs have shaped the company as the FDA’s compliance requirements changed.
• Emergency Use Authorization (EUA)
• Pre-market Approvals (PMA),
• Investigational Device Exemptions (IDE),
• Premarket Submissions (510K),
• De Novo submissions
• Humanitarian Device Exemptions (HDE),
• Human Factors Studies,
• Label reviews,
• Pre-submission and Q-Sub submissions,
• Quality Systems based on Part 820,
• Preparing medical device and certain drug
companies for FDA quality system inspections,
• Preparing medical device companies that have received 483 Observations in their response to the observations,
• U.S. Agent,
• Initial Importer,
• Responses to warning letters for medical and IVD companies, and
• Recalls and Corrections Having established years of experience in the medical device consulting space, Smith Associates understands there are many moving parts to any FDA application or submission that mandates expert guidance along every step of the journey.

“Our consultants have over 100 years of FDA regulatory and sales or marketing backgrounds and business ownership. We understand the regulatory side of submission and the marketing side of the business,” says E J Smith, President, Smith Associates.

We understand the financial pressures placed on businesses when trying to comply with FDA regulatory requirements and the costs of performing expensive testing to demonstrate the safety and effectiveness of their device to that of the predicate device.

As consultants it is vital that we Identify the correct reviewing branch, regulation number, product code based on the device’s intended use and Classification (I, II, III), and from that selected classification, the best predicate to support substantial equivalence. A comprehensive checklist is also developed from the information gathered and shared with the client.

“There is more to a submission than the submission itself,” says Yolanda Smith, Vice- President. We prepare the client for pre-production requirements in design control and quality system documentation that support the subject device when Office of Regulatory Affairs (ORA) Investigators audit their quality system. We ensure that the complete regulatory documentation submitted to the FDA as a 510k or PMA and all FDA communication during that process is provided to the owner for his design history files (DHF).

We encourage clients to call us with their regulatory 510(k) questions, and these are no charge conversations, in most cases” says Dennis A. Repella, Chief Scientific Officer and Process Validation Expert. Smith Associates, with an extraordinary medical device expertise team, and many years of medical device industry experience, has cleared over 300+ 510(k) medical devices, to date, in addition to PMA and IDEs and countless Presubmissions.

There is more to a submission than the submission itself. We prepare the client for post clearance in design control and quality system documentation that support the subject device when Office of Regulatory Affairs (ORA) Investigators audit their quality system. We encourage clients to call us with their regulatory 510(k) questions, and these are no charge conversations

The Pre-submission provides our client’s the means to interact with the FDA before filing their submission. Questions can be directed to the FDA from concept to feasibility phase to transfer to manufacturing. It helps smooth the submission process by pre-review of protocols, predicates or proposed testing. Having expensive Human Factor Studies and proposed third laboratory testing reviewed by the FDA can save significant time and money. It is to our advantage and the FDA’s to have these questions answered via Pre-submission rather than during the 510k review. It also gives the FDA a heads up that you are going to file and begins your relationship with the FDA.

“We had the luxury of scaling up and growing with our clients, which accounts for 29 years of experience in this field,” says Christian Smith, Principal, Smith Associates. Today, Smith Associates continues to be devoted to taking its clients’ FDA medical device approvals by assisting them in every step, ensuring quality consulting at an affordable fixed fee.