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Medical Device & Diagnostic Industry Magazine
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An MD&DI May 1997 Column


Associate vice president and special counsel for HIMA commends FDA for its recent reforms but urges the agency to continue change.

If FDA wants to promote rather than stifle innovation, it must continue to modify its inspection procedures. In the past, an FDA inspection of a manufacturer's facility was often an adversarial encounter: FDA's goal was to collect evidence for prosecution or another type of regulatory action. But in the mid-1990s, reduced congressional funding forced the agency to reevaluate its operation. Practical suggestions from industry convinced forward-thinking FDA officials to take action. FDA has since begun the process of changing its procedures. Even though both industry and the White House have acknowledged FDA's efforts, much work remains to be done.


FDA's mission, which was revised in July 1995, states that the agency is a team of dedicated professionals working to protect and promote the health of the American people. FDA is responsible for ensuring that . . . products are in compliance with the law and FDA regulations; noncompliance is identified and corrected; and any unsafe or unlawful products are removed from the marketplace.

For many years FDA maintained a different stance. To carry out its mission, it developed manuals explaining its regulatory philosophy. These manuals, available to the public from the National Technical Information Service, specifically define an investigator's responsibility during each step of an FDA inspection. Subchapter 150 of the Investigations Operations Manual (IOM) explained,

All regulatory procedures are designed to discover and develop evidence of violations with the ultimate aim of assuring compliance with the law and protection of the public.

According to David Haggard, director of FDA's Division of Compliance Policy, this statement was not in line with the agency's philosophy and has been deleted from the manual. FDA's current philosophy for inspections, which, according to Haggard, is more appropriately reflected in section 502 of the IOM, states,

An establishment inspection is a careful, critical, official examination of a facility to determine its compliance with the laws administered by FDA. Inspections may be used to obtain evidence to support legal action when violations are found, or they may be directed to obtaining specific information on new technologies, good commercial practices, or data for establishing . . . regulations.

This subtle shift in philosophy shows that the agency is learning it must work with device companies to improve regulation. It has also modified its thinking about the objectives of the inspection process. Perhaps, after the new quality system regulation is implemented, the description might be further modified to reflect a more positive purpose, such as verifying that a company is producing safe and effective products that comply with its internal quality procedures.

Unfortunately, the IOM still encourages investigators to be aggressive when requesting records to which they are not legally entitled. Section 514 states,

Refusals must be also discussed in the EIR [establishment inspection report] whether or not it is [sic] a refusal of legally required information. Provide comprehensive details on all refusals in your EIR under the heading captioned "A Refusal to Permit Inspection."

FDA should delete this section from the IOM. Industry regulatory experts report that responding to an investigator's request for data that FDA is not entitled to is one of the most terrifying challenges they face.


In 1994, the Health Industry Manufacturers Association (HIMA) polled industry on its concerns and developed recommendations to improve the inspection process. Using these suggestions, HIMA officials began meeting regularly with Ron Chesemore, Gary Dykstra, and Debbie Ralston from FDA's Office of Regulatory Affairs and Bruce Burlington and Lillian Gill from the Center for Devices and Radiological Health. The suggested items included:

  • Conducting preannounced inspections.
  • Annotating the FDA-483 with completed or promised corrective actions.
  • Requiring that observations on the FDA-483 be put in context (e.g., the inspector examined 50 complaints and found that only 3 had not been reported as medical device reporting [MDR] items).
  • Promoting and recognizing investigators for working with industry to achieve compliance rather than initiating regulatory actions.
  • Having medical device specialists perform inspections.

After listening to these suggestions in meetings at FDA headquarters, in grassroots meetings around the country, and during FDA's teleconference on compliance, agency officials met with an industry group chaired by Wendell Gardner, senior vice president for COBE Laboratories, Inc. (Lakewood, CO). The agency, aware of its diminishing resources and the group's reasonable suggestions, decided to implement a pilot program that included the following features:

  • Preannouncing inspections.
  • Annotating the FDA-483 to include corrected items and putting observations in context.
  • Issuing close-out letters after inspections were completed.

The program was so successful that this March these pilot program features became part of FDA's standard operating procedures (SOPs) for conducting medical device inspections.

One important feature of the pilot program that was not incorporated into the SOPs was the provision allowing the companies under inspection to evaluate investigators for following the spirit of the pilot and to judge whether the program improved communication. The fact that investigators knew they would be evaluated when the inspection ended appeared to improve communication between the investigators and the companies.

FDA should reinstate this provision. To preserve anonymity and quash industry fears of retribution, FDA should have companies send evaluation forms directly to headquarters or to a third party rather than to the investigator's district director.

Another initiative that FDA has implemented is a certification program for medical device investigators. Its primary objective is to educate investigators about the medical device industry and specific technologies so they can conduct better investigations. In addition, the certification program promotes uniformity in the enforcement of FDA's regulatory responsibilities. Industry supports this effort, and medical device manufacturers are eager to work with FDA to provide training on emerging technologies.

In response to industry's concern about linking awards and promotions to an investigator's success in detecting and supporting regulatory actions, FDA in 1995 initiated the compliance achievement reporting system (CARS). This system allows frontline regulators to enter compliance accomplishments into a database. The information can be used to reward investigators for working with industry to achieve voluntary compliance. Industry applauds this initiative but wants to work with FDA in an oversight capacity to ensure that corrective actions are voluntary, and that individual investigators are not encouraging companies to change their procedures just so the investigator can receive recognition.

To get more feedback on specific initiatives, FDA invited industry from Dallas and Boston to meetings on ways to facilitate effective communication between FDA and industry. FDA has also met with industry during grassroots meetings in Atlanta, Charlotte, and Orlando. During these meetings, attendees were polled on ways to improve the inspection process. Their suggestions included:

  • Conduct joint training of industry and FDA investigators on the new requirements under the quality system regulation and MDR requirements. Rationale: Training FDA investigators and members of industry together minimizes the chance of interpreting specific requirements differently.
  • Provide EIRs automatically to companies after inspection. Rationale: If the purpose of an inspection is to judge a company's compliance with regulations, the company should have access to FDA's conclusions about its compliance status as soon as possible after inspection.
  • Mandate that FDA investigators be permited to request only that information to which they are specifically entitled under the law. Rationale: By having FDA investigators request only what they are specifically entitled to under the law, industry officials will be less intimidated during FDA inspections.
  • Issue warning letters from headquarters rather than from the field. Rationale: The industry needs to operate in an environment that is predictable and consistent throughout the country. Empowering individual districts to issue warning letters allows for various interpretations of the regulatory requirements and reduces predictability for companies that have plants in several districts. Having a centralized office at FDA issue or approve the issuance of warning letters will help ensure that similar conditions receive similar sanctions.
  • Do not include in a warning letter items that have been corrected or that the company has promised to correct. Rationale: Investigators annotate FDA-483 items with information about performed or promised corrective actions. The purpose of a warning letter is to put companies on notice that, if they fail to correct the listed conditions, FDA will take regulatory action against them. Because the FDA-483 already lists the conditions, repeating the items that companies have corrected or have promised to correct serves no useful purpose.
  • Give companies 5 to 10 days to respond to an FDA-483, include the response in the warning letter, and allow FDA 20 days to send out a warning letter. Rationale: By increasing time frames, companies will have more time to provide a thorough response to the FDA-483. Then FDA can read the response and include it in the warning letter if necessary.

In response to the suggestion to provide joint training, FDA's Southwest Region conducted joint training for FDA and industry personnel on how to comply with the MDR requirements. FDA also conducted joint training on how to comply with the design control portion of the new quality system regulation. Moreover, in response to the suggestion to provide EIRs automatically to companies after an inspection, the agency set up a pilot program to do so temporarily. Industry is optimistic that FDA will continue to conduct grassroots meetings and implement these suggestions and others that arise from those meetings.


Quality System Regulation. Although it mandates the requirements for quality systems, FDA's new regulation allows manufacturers to develop systems that meet their individual needs. Because the regulation is written in a nonprescriptive manner, investigators should not be prescriptive during inspections.

The National Performance Review. The National Performance Review program to reinvent government shows that the government realizes that the majority of firms in any industry, including the medical device manufacturing industry, want to comply with clear, reasonable, and predictable regulatory requirements. To keep in line with this philosophy, FDA should enter into productive partnerships with the majority of firms to allow innovation and promote voluntary compliance. By doing so, inspection time should not be focused on the majority, which are essentially in compliance with the law, but rather on the minority that seek to get around the rules.

In 1996, Jean Logan from the National Performance Review and Marie Urban from FDA's Office of Regulatory Affairs began to look for occasions on which FDA entered into productive partnerships with the medical device industry. On five occasions, FDA personnel from the districts and from headquarters were recognized for partnering with industry and received the National Performance Review's Hammer Award. On three of these occasions the industry partners of FDA--HIMA, FDLI, and Storz Instrument Co. (St. Louis, MO), respectively--were also presented with the award.

FDA Reform. The slowdown in product approval in the 1990s, competition from overseas companies, the drying up of venture capital, the movement of research and development overseas, and the Republican Congress have prompted industry to work to achieve legislative reform of FDA.

One goal of such reform is the establishment of a reasonable and predictable regulatory environment that does not depend on the incumbent FDA commissioner or center directors, but rather on a statute about which FDA officials have limited discretion. FDA has consistently contended that it needs unlimited power, and that industry should trust it to use that power judiciously. Conversely, industry's position has been that FDA should be given power judiciously.

Industry's efforts to achieve legislative reform may have motivated FDA to implement many of industry's suggestions. Although industry is pleased by FDA's actions, without legislative reform there is no guarantee that the changes will be permanent.

FDA, industry, and Congress need to work together to develop regulation that allows companies to operate in a reasonable and predictable regulatory environment based on law rather than on the discretion of the officials who are charged with carrying out the law.


In any regulatory system, abuses can occur when the government operates in isolation. For the past few years, the White House, Congress, and the press have focused on the challenges brought on by FDA regulation. On the positive side, FDA has worked with industry on many new programs to produce a regulatory environment that is more reasonable and predictable than before. Industry's continuous assistance will help the agency build on its recent successes.

Copyright ©1997 Medical Device & Diagnostic Industry
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