Originally Published MDDI March 2003
The Office of Device Evaluation takes most of the credit for the improved numbers. A closer look reveals industry deserves even more credit.
James G. Dickinson
In 2002, CDRH's Office of Device Evaluation (ODE) decreased its PMA review time by 11.4% from the previous year. The 68 review decisions ODE made last year averaged 364 days from submission to decision, compared with 411 days the year before. These statistics and others are presented in ODE's latest annual report.
ODE takes a good deal of credit for these numbers. But a closer look reveals that industry deserves even more credit, for such time-savers as better-quality submissions and better data organization in documents.
FDA time from PMA filing to making a decision fell from 218 days in 2001 to 203 days last year—a 7% improvement. On the other hand, non-FDA (sponsor) time in the same period fell from 47 to six days—an 83% improvement.
One table in the report gives an incorrect impression of worsening FDA performance in the review of PMAs. It shows an increase in FDA time from 129 days in 2001 to 160 days last year. This was picked up by some media reports, but ODE director Daniel Schultz told MD&DI that the misleading table counts only the final cycle of PMA reviews. Nearly all PMAs have more than one cycle, but although the final-cycle review time increased, FDA saved time in the review of earlier cycles.
Other review improvements in the report include the elimination of last year's backlog of pending PMA supplements that had existed since at least 1998. However, despite this positive change, FDA processing time for those supplements increased last year to an average 85 days, from 71 the year before.
In ODE's favor last year was the substantial decline in the number of original PMAs it received. Only 48 came in, which was 23 fewer than the number received in 2001.
Less encouraging are the statistics on 510(k)s. Here, ODE is still beleaguered by a lack of resources, something the Medical Device User Fee and Modernization Act will hopefully fix in 2003. After two years of slowly dwindling 510(k) receipts, last year there was a slight uptick to 4320 from the prior year's 4254. Average review time increased as well, by an average of four days, to 100.
Guidance on Sharps Injury Prevention Devices
CDRH has released a supplementary guidance for industry and FDA titled "Supplementary Guidance on Premarket Notifications for Medical
Devices with Sharps Injury Prevention Features." The December 31 document assists manufacturers, distributors, or importers submitting 510(k)s for devices incorporating a sharps injury prevention feature and for sharps injury prevention accessories. It also promotes consistency in 510(k) content and guides FDA staff in conducting and documenting 510(k) reviews for both devices with sharps injury prevention features and accessories for preventing sharps injury. The supplementary guidance supersedes 1995's "Draft Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions for Medical Devices with Sharps Injury Prevention Features (Antistick)."
The updated document states that a 510(k) for a device with sharps injury prevention features should contain seven main items. These include a cover letter, information required by the Safe Medical Devices Act of 1990, labels and labeling, a device description, a comparison to a legally marketed device, verification and validation test data, and a sample device. Labeling should be provided in sufficient detail to describe the device, its intended use, and the directions for its use. The draft guidance says FDA will assess the device based on the indications for use or intended use statements in the submitted labeling. If the labeling is not explicit, the applicant should cite the intended use that is commonly understood by healthcare professionals for the specific device. Included in the supplementary guidance are six directions for use that should be considered by a sharps injury prevention device sponsor.
FDA requires that each 510(k) submission identify a legally marketed device that is similar in intended use and technology. According to the guidance, the sponsor should compare and contrast the following aspects of its own sharps injury prevention device and the comparison device:
• Design features and specifications.
• Intended use.
• Other aspects of labeling.
• Materials of construction.
• Technological aspects.
For validation and verification testing, device sponsors are urged to submit bench, biocompatibility, and simulated clinical use test data. Preclinical and actual clinical use data should be submitted when requested, or as noted in the supplementary guidance. The draft supplementary guidance may be accessed at www.fda.gov/cdrh/ode/guidance/934.pdf.
FDA Seeks Quick Input from Industry
FDA wants quick input from industry to help clearly define different supplement submissions under the Medical Device User Fee and Modernization Act of 2002. Several provisions under the act require immediate implementation, the agency says, to track performance goals that FDA must meet in the coming years, and to collect fees. With regard to supplement submissions, FDA says it wants feedback on how best to define panel-track supplements, 180-day supplements, and real-time supplements.
FDA also seeks help in establishing a "bundling policy to define when bundling multiple devices, device modifications, or indications for use into a single submission is appropriate versus when separate applications should be submitted." Additionally, the agency is calling for comments on the implementation of its modular review program for PMAs. For more on FDA's request, visit www.fda.gov/cber/mdufma/mdufma.htm.
Ulatowski to Head Device Compliance at FDA
CDRH director David Feigal recommends Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices director Tim Ulatowski for Office of Compliance director. CDRH has been without a permanent compliance director since Lillian Gill joined Feigal's office as acting center director for science in June 2000.
According to an e-mail from Feigal, Ulatowski began working at FDA in 1974. He first served as a microbiologist in the C-Street labs conducting antibiotic analyses and sterility tests. Ulatowski then progressed to consumer safety officer (CSO) in the former Office of New Drug Evaluation. He was the executive secretary and product manager for the oncology, radiopharmaceutical, and antiinflammatory drug product groups. He moved to CDRH in 1980 and worked in the Office of Device Evaluation as a CSO with the program operations staff. He then became director of the investigational device evaluation staff before assuming his current role.
He earned a BS from Penn State and an MS from Georgetown University. His fields of study included microbiology, engineering, and computer science.
FDA Reassures Public on Dental Amalgams
In a recent FDA Consumer Update, the agency reiterated that dental amalgams used in dental restorations (fillings) are not harmful to patients. According to the agency, "no valid scientific evidence has shown that amalgams cause harm to patients with dental restorations, except in the rare case of allergy." In a previous Consumer Update, FDA also cited a lack of “valid scientific evidence” to disprove dental amalgam safety. Additionally, at a House government reform hearing last November, CDRH director David Feigal noted the lack of evidence linking amalgam use to systemic-disease onset.
However, FDA said it—as well as the U.S. Public Health Service (USPHS)—will continue its investigation into the safety of amalgams. "The USPHS," FDA said, "will continue gathering data about possible risks of dental amalgams and other restorative products, and pursuing new methods of dental treatment." The Consumer Update article can be accessed at www.fda.gov/cdrh/consumer/amalgams.html.
Warning on Diathermy Risks
FDA recently warned physicians against using shortwave or microwave diathermy devices on patients with implanted metallic leads or systems that may contain a lead. The agency said both heating and nonheating operational modes pose a risk of tissue destruction in these patients.
In the notice, CDRH director David Feigal said FDA has received reports of two patients with implanted deepbrain stimulators who died following diathermy therapy. One patient received diathermy following oral surgery, the other for treatment of chronic scoliosis. In both cases, he said, the interaction of the diathermy currents with the implanted device caused severe brain damage where the lead electrodes were implanted.
Feigal urged physicians who implant or monitor patients with leads or implanted systems with leads to explain to each patient what diathermy is and stress that patients should not receive shortwave or microwave diathermy. Healthcare professionals who use diathermy in practice were urged by Feigal to ask the patient about possible implants before deciding to administer diathermy therapy. He also requested that they not administer diathermy to a patient who has had an implant in the past unless they are absolutely certain that the implant and all leads have been removed. Feigal's notice can be viewed at www.fda.gov/cdrh/safety/121902.html.
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