Originally published February 1996
The FDA good manufacturing practices (GMP) inspection process can be something of a mystery even to well-established medical device companies. Start-up companies have even less knowledge of what the agency focuses on during its inspections and may stumble badly during a preapproval or routine GMP inspection. Fortunately, the agency has a program to help all types of FDA-regulated industries achieve voluntary compliance with the laws and regulations it enforces. FDA's Small Business Assistance Program offers a unique opportunity for small and start-up companies to obtain confidential advice on compliance and to avoid situations that could delay product approval.
The objectives of this service program are to provide an efficient way for small businesses to obtain general guidance for compliance requirements and to reduce the complexities faced by small businesses in dealing with a large bureaucratic organization.
FDA's Office of Regulatory Affairs (ORA) is divided into six regions, each with a small business representative. The representative administers the regional Small Business Assistance Program and responds to industry inquiries about current FDA policies and legal and regulatory requirements. The response can vary from sending out forms and publications to providing regulatory guidance and technical assistance through phone calls or on-site visits. Through these regional representatives, manufacturers receive help much more rapidly than if they had telephoned or sent written requests to a headquarters office. Representatives also participate in industry meetings, conferences, and workshops and provide guidance pertaining to regulated products and regulatory policy.
The regional representatives are responsible for addressing the needs of all FDA-regulated industries, including foods, drugs, cosmetics, medical devices, biologics, and veterinary products. The Division of Small Manufacturers Assistance (DSMA) in the Center for Devices and Radiological Health is specifically focused on the needs of the medical device industry. Although the field representatives are part of ORA and not directly connected to DSMA, they do work closely with the division, as well as with the Office of Compliance and the Office of Device Evaluation, on issues that affect the medical device industry.
One of the most valuable services this program makes available to industry is the on-site visit. While on-site, the representative may conduct informal audits of the company's compliance with FDA requirements or participate in employee training programs, detailing the laws and regulations pertaining to their products. For instance, the forthcoming revision of FDA's medical device GMP regulation makes reevaluation of a firm's operations essential.
These visits also allow a company to express its concerns about proposed, pending, or revised regulations; the representative can then convey those concerns to the appropriate headquarters center office. Based on personal experience and suggestions from local small manufacturers, the representative can also advise the appropriate FDA center about the need for new educational programs and help develop such programs.
Representatives do not report to a local or headquarters compliance office. Unless an obvious and imminent health hazard is detected, representatives make no report about the company's compliance status. Local district offices are restricted from inspecting a facility for 60 days after a representative's visit, allowing the company time to voluntarily correct any noncompliant conditions. In the Pacific region, for example, since the program's inception in 1979 no on-site visit has resulted in a direct regulatory follow-up inspection or in FDA action against a company by the local district office. Representatives do maintain contact with the local compliance office and will not visit a firm that is currently involved in regulatory action unless asked to do so by the local district management and the company.
This program is intended to help the small business community achieve voluntary compliance before a regulatory inspection takes place, and to prevent regulatory problems before they occur. Industry is encouraged to use this program whenever it has doubts about whether a particular process or procedure is in compliance with the requirements set forth in the regulations. Whether a company needs information related to getting its product approved and on the market or needs copies of an FDA regulation, this FDA program can help. Unlike the Small Business Administration, FDA does not define a "small" business as one with fewer than 500 employees. The agency will assist any company that requests help regardless of the number of its employees.
The program does have some restrictions. For example, regional representatives can-not intervene between a company and the local district office following an inspection that reveals noncompliant conditions. Nor can representatives change or remove any item noted as objectionable during a compliance inspection.
Although FDA is actively reorganizing, it currently has six headquarters centers and 162 field offices. In each of the six regional offices, FDA has a small business representative who is available expressly to assist with the special concerns of small and start-up companies new to the regulatory arena.
The small business representative can clarify agency laws and regulations, suggest methods for meeting these requirements, respond to specific problem- or product- related inquiries, conduct or participate in workshops and conferences, and visit a company's facility at its request. Companies that believe a site visit to their facilities would be helpful should contact the representative in the regional office that serves their location.
Mark Roh has administered FDA's Small Business Assistance Program in the Pacific Region since 1990.