Originally Published MDDI August 2004

Reflections

A newly regulated medical device industry found itself in need of lots of training. FDA and industry worked closely together to make it a success.

Andrew Lowery

Andrew Lowery spent 20 years as associate director of quality systems  at FDA's Division of Small Manu- facturers Assistance (Rockville, MD). He is currently a consultant to the medical device industry.

In the early years after Congress mandated the regulation of the medical device industry, FDA sought the assistance of other organizations to help educate the industry on the 1976 Medical Device Amendments and related regulations. Canon Communications held a unique position in the medical device industry when it began publishing MD&DI in 1979. As a primary industry resource, MD&DI was ideally suited to its role as an educational tool for manufacturers and FDA alike.

Small Steps

When the Medical Device Amendments were added to the Food, Drug, and Cosmetic Act in 1976, Congress recognized that the medical device industry, particularly small manufacturers, would need to be brought up to speed quickly on the implications of the new regulations. When the good manufacturing practices (GMP) regulation was about to be published, FDA's Office of Regulatory Affairs and Bureau of Medical Devices (BMD, now CDRH) Office of Compliance conducted a road show around the United States. FDA continued with GMP seminars and, in 1978, it began educational visits to manufacturers. Its training materials consisted primarily of a compendium of commonly asked GMP questions and answers, a concordance of the GMP regulation, and a copy of the preamble to the GMP. 

BMD's director recognized that the GMP training program was being presented from a regulatory perspective, and the terminology was new and unfamiliar to manufacturers. Manufacturers needed information that related the new regulations to their own accepted quality practices. Problems communicating existed on both sides. For example, during inspections, FDA investigators would ask manufacturing personnel whether the company had a device master record (DMR) on file. The manufacturers would often reply, “No,” which thus resulted in the apparent GMP deficiency appearing on the investigator's FDA 483 List of Observations for the company.

In most cases, the manufacturers actually did have and did use a set of engineering drawings and procedures for producing their devices—FDA's definition of a device master record. Sometimes, though, neither the investigator nor the manufacturer knew the two were one and the same. It was obvious that both FDA and industry needed cross-training on GMP requirements and terminology.

The BMD director hired industry specialists in 1979 to augment the existing training provided by FDA GMP experts. The agency also greatly expanded the amount of its training activities. The result was a broad-based and extensive training program. However, the medical device industry was growing very rapidly. FDA educators had difficulty meeting the demand for seminars, and staffers could barely keep up with the questions streaming over the phone lines. FDA educators in the Office of Small Manufacturer's Assistance (OSMA) and in the Office of Compliance found themselves eating lunch with one hand while answering the phones with the other.

To address the problem, FDA produced a series of manuals, including a regulatory manual that covered registration, listing, importing, and 510(k) and premarket approval (PMA) applications; a GMP manual; and a sterility manual. The manuals were developed by OSMA (later DSMA, and then DSMICA) with input and review from the Office of Compliance, the Office of Device Evaluation (ODE), FDA legal counsel, and other agency offices.

Giant Leaps

The manuals and associated seminars that began in 1981 were a giant leap forward, but they still fell short of addressing the response level needed. The agency could not accommodate the sheer volume of requests for regulatory information. It was also nearly impossible to adequately address the many technical and scientific issues related to the development of devices and the development and control of manufacturing processes. It became clear that the industry needed to provide more of its own regulatory education, including related technical and scientific issues, on a continuing basis.

In response, several industry organizations expanded or modified their educational programs in the early 1980s. Canon Communications was in a unique position to make significant contributions to this area through its conferences and magazines. The pages of MD&DI offered a wealth of information on major conferences, consultants, device components, raw materials, quality assurance, materials, and equipment. Articles focused on the development, labeling, safety, regulatory clearance, production, control, and distribution of medical devices. Its conferences each year covered these same topics. All of this was synergistic with the FDA educational program and its congressional mandate. In addition to ongoing regulatory topics, FDA worked closely with Canon and other industry organizations to provide conference speakers for topics that needed special emphasis.

The Fast Track

In the last 25 years, the industry has made much progress, and its relationship with FDA has been more like a partnership. FDA training still involves speaking at conferences and meeting one-on-one with industry, but these activities have been supplemented with regularly published guidance documents and improved access to reviewers. Moreover, the Internet and e-mail have opened a whole new door for providing information to industry quickly and efficiently. Not only has FDA been able to disseminate much information via its own Web site, but Canon's www.devicelink.com also provides critical industry information in a way never offered before.

Congress may have given FDA and the device industry a giant hurdle, but together we've managed to clear it with room to spare. The journey wasn't always easy. However, with FDA officials and staff committed to helping the industry and the dedication of the industry and its organizations, the process has been one of communication, cooperation, and success. 

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