Originally Published MDDI December 2002
Implementation of the concept will help to expedite the availability of new technology, says the agency.
James G. Dickinson
After reviewing recommendations on the draft guidance, FDA has published the final least burdensome guidance. "When conscientiously applied," the agency states in its final least burdensome guidance, "we believe the least burdensome concept will help to expedite the availability of new device technologies without compromising scientific integrity in the decision-making process or FDA's ability to protect the public health."
The guidance, entitled, The Least Burdensome Provisions of the FDA Modernization Act of 1997; Concept and Principles; Final Guidance for FDA and Industry, says FDA has acceded to recommendations from draft guidance comments that it should develop additional in-depth training sessions to ensure that the least burdensome approach is incorporated at CDRH and CBER. The agency has also created tools for evaluating approach implementation, including checklists to be used following the early collaboration meetings called for by FDAMA.
The final guidance defines the term least burdensome as "a successful means of addressing a premarket issue that involves the most appropriate investment of time, effort, and resources on the part of industry and FDA." According to the final guidance, general applications for the least burdensome approach include a "systems approach" to device regulation. When requesting additional information to resolve a regulatory issue, the guidance says, FDA should follow four guidelines: one, identify the specific issue or question to be addressed; two, acknowledge the submitted information and explain why it is deficient; three, establish the relevance of the request to the determination that is being made (e.g., substantial equivalence or reasonable assurance of safety and efficacy); and four, remain open-minded to alternate ways to address the issue or question.
When responding to FDA's requests, industry "should make every attempt to respond completely and promptly." Industry should state the agency's issue and provide either the information requested or one of the following: an explanation of why the issue is irrelevant in determining substantial equivalence or a reasonable assurance of safety and efficacy, or alternative information and an explanation as to why this information adequately addresses the issue.
Additional applications of the least burdensome approach include a reliance on postmarket controls to reduce the burden associated with PMAs and 510(k)s, and an effective use of well-designed bench and animal testing. Whenever possible, industry should incorporate by reference other premarket submissions as a means of saving resources. According to the guidance, FDA should also avoid using premarket review to ensure compliance with statutes and regulations unrelated to the regulatory decision.
The guidance can be viewed at http://www.fda.gov/cdrh/ode/guidance/1332.html.
FDA told Gliatech Inc. (Cleveland) that it has adequately completed required audits and corrective actions under the agency's Application Integrity Policy (AIP), and that the agency will resume review of the company's submissions. Earlier this year, the troubled device maker entered into a plea agreement, which included a $1.2 million fine, with the U.S. Department of Justice to settle an FDA Office of Criminal Investigations probe into alleged wrongdoings involving its market-withdrawn, scar-inhibiting Adcon-L barrier gel.
The company's FDA problems began three years ago when the agency issued an import alert on the contract-manufactured product following an inspection and the issuance of a warning letter to its Netherlands-based supplier, Medical Contract Manufacturing. Further difficulties arose eight months later, when an FDA inspection questioned company data and the process it used in presenting the data in a supplemental PMA application for Adcon-L. The company subsequently removed the product from the U.S. market and FDA placed the firm on its AIP list.
According to Gliatech, FDA has said that for a period of two years all submissions related to Adcon must be certified by an independent auditor before they are submitted to the agency. Adcon-L has been relaunched outside of the United States. The Adcon product line is up for sale as part of the company's bankruptcy proceedings and if it is sold, the new sponsor will need to resubmit a PMA to the agency to market in the United States.
CDRH is developing a new framework of "probability" sampling of medical device company quality systems to look at areas where there could be an increased risk sufficient to warrant more-frequent or more-targeted inspections.
Center director David Feigal said at a Regulatory Affairs Professionals Society meeting on October 7 that this approach had recently been tested among about 100 companies that manufacture only Class I devices—a sector that for almost six years has been exempt from routine inspections. FDA selected the sampled firms for one-day inspections because of a recent rash of product recalls and because the agency identified the sample as representative of the 5000 companies that make only Class I devices.
So far, Feigal said, the inspection data are preliminary, but "there were only a small fraction of firms found to be violative." But he also noted that only nine firms had in place corrective and preventive action systems and other good quality systems. Over the next year as it analyzes the data, the center will report on quality systems issues and common deficiencies for this segment of the industry.
Feigal sees probability sampling fitting into his center's risk-based strategy. He said this tool and others will help the agency move from coverage-based inspections to those that deal with identified issues. Gone are the days when the center measured success by reporting that 40% of Class II devices had been inspected during a specific year. "We'll now be talking about the kinds of risks that we are aware of and how we targeted the inspectional process to reduce those risks, and what are our findings."
The important thing, Feigal said, is to provide industry with information on the common inspectional findings FDA is discovering, so these situations can be addressed and corrected if they potentially can occur in other areas of manufacturing.
According to Venetec International (San Diego), FDA should ban the use of sutures for securing catheters because the needles unnecessarily expose physicians and nurses to viruses such as hepatitis C and HIV. So said the company in recent comments on a two-year-old Public Citizen petition seeking such a ban. The petition asked FDA to ban all intravenous catheters, blood collection devices, blood collection needle sets (also known as butterfly syringes), glass capillary tubes, and intravenous infusion equipment that do not use needleless technology or recessed needles, including intravenous catheters and related infusion equipment.
In its comments, Venetec noted several reasons for an FDA ban on suture securement. Sutures have been used in the past only by default, in the absence of proven alternative technology, the company said, and a proven alternative now exists, in the form of sutureless securement devices (i.e., Venetec's Statlock device). Also, sutureless securement devices comply with the federal Needlestick Safety and Prevention Act, as well as with regulations issued by the Occupational Safety and Health Administration, and sutureless securement devices have been recognized by the congressional authors of the Needlestick Safety and Prevention Act. Furthermore, sutureless securement devices are widely available and used in numerous U.S. healthcare institutions.
In a related move, the National Alliance for the Primary Prevention of Sharps Injuries (NAPPSI), founded by Venetec International, petitioned FDA to post and distribute its Needlestick Safety Device List—an up-to-date compilation of technologies that reduce or eliminate healthcare workers' exposure to needlestick injuries.
FDA is expected to rule in the coming months on Venetec's requests, as well as on the initial petition from Public Citizen.
Monitoring temporary pacemaker connections, selecting a third-party reprocessor, and hazards in patient-controlled analgesia are among the topics addressed in the latest issue of User Facility Reporting—CDRH's quarterly bulletin to assist hospitals, nursing homes, and other device-user facilities. The issue provides a brief synopsis of each topic with links to the information on-line.
In the article "Monitoring Temporary Pacemaker Connections," Diane Dwyer, a CDRH Office of Surveillance and Biometrics nurse consultant, describes a case in which a patient admitted to an ICU died following the insertion of a temporary invasive cardiac-pacing catheter. Because the catheter pin design was incompatible with the pacer adapter, Dwyer says, it could not be connected to the pulse generator. The patient was instead connected to a transcutaneous pacemaker and died shortly after arrival at another facility.
Another article advised facilities selecting a third-party reprocessor of single-use devices (SUDs) to talk with other hospitals to determine their experiences, and to arrange a visit to the reprocessor's facilities. Questions to consider asking a potential reprocessor include:
- When did FDA last inspect the facility? What were the inspection results?
- Does the facility have documentation that the company is approved or cleared for each type of SUD reprocessed?
- How does the facility monitor manufacturing processes and what records are maintained in compliance with FDA's quality system regulation?
- What aspects of the overall process have been validated?
- Has the company set limits on the number of times an SUD can be reprocessed? If yes, how was that number determined and what procedures are in place to make sure that number is not exceeded?
To view the latest issue of User Facility Reporting, visit http://www.fda.gov/cdrh/fusenews/ufb40.html.
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