An MD&DI August 1999 Column
WASHINGTON WRAP-UPPrivate-sector reviews of 510(k) submissions average 33% faster than those conducted by the agency.
- Agency Will Audit Device Data for Y2K Compliance
- FDA Guidance on Reporting Y2K Problems
- Advisory Committee Questions Now on the Web
- FDA Approves Bone-Density Test Device
- Inspectors Going High-Tech
- Withdrawn Flush Syringe Is Approved
- Bladder Cancer Test Needs More Data for FDA Approval
- Down-Classifying Shoulder Prostheses
- Home Uterine Monitor 510(k) Draft Guidance
You always suspected it: private-sector device reviews for marketing approval just had to be faster than anything FDA could do. Although a full-scale third-party device review program isn't yet up and running (why pay for something FDA does for free?), limited experimentation with private device reviews bears out your canny instincts.
In May, FDA's Office of Device Evaluation (ODE) reported that the median review time of its pilot third-party review program for selected low- and moderate-risk devices that ended on November 21, 1998, was 29 days faster than the median review time of the agency staff for 510(k)s. Total elapsed time from the date of a third party's receipt of a 510(k) to the date of the final FDA decision was a median of 54 days (with an average of 78 days), while the median review time for all in-house 510(k)s was 83 days. More than 90% of all third-party reviews had less-than-90-day FDA cycles.
The ODE annual report for fiscal year 1998, posted on the agency Web site in May, reports that the 31 510(k)s that had been reviewed by third parties were received between August 1996 and July 1998. By the end of the fiscal year, ODE had issued final decisions on 30 of the 510(k)s, with one held for additional information. ODE's final decision matched the third-party reviewer's recommendation in 29 of 30 applications and was issued without the need for additional information in 55% of the submissions. Once the pilot review program ended on November 21, 1998, it was replaced by the Accredited Persons program established under FDAMA.
The ODE report also indicates that the average review time for premarket approval (PMA) applications was cut by 25% compared with the previous year. During FY 1998, there were 46 PMAs approved, 7 under expedited review and 4 as humanitarian device exemptions. Of the 46 approved PMAs, 18 took 180 days or less, and 37 were completed in less than one year. Also approved were 427 PMA supplements, with 139 reviewed in real time. Average FDA review time for original PMAs reaching final action decreased from 207 days in FY 1997 to 154 days in FY 1998. The total average review time decreased to 6.4 months, marking the fourth consecutive year the total average review time has gone down.
Reversing an earlier stance, FDA now says it plans to audit the data of a sample of medical device manufacturers to ensure the devices will not malfunction in 2000 as a result of computer problems. Acting deputy commissioner for policy William Hubbard testified in May before a joint hearing of the House Commerce Committee's subcommittee on health and the environment and the House Oversight and Investigations Committee that the agency is seeking funding to audit data of manufacturers of 60 high-risk devices that could threaten patient health or safety if they malfunction on January 1, 2000.
FDA had said it saw no need to verify Y2K information provided by device manufacturers, but that position had been challenged by the General Accounting Office (GAO), Congress's investigating and research body. The GAO reported that some hospitals had tested devices shown on the FDA Web site as being Y2K compliant and found that they malfunctioned.
Even though the audit is to be done, Hubbard explained, the potential medical device problem is not as serious as some observers have claimed. "FDA believes that the information received to date confirms our original expectation that the year 2000 problems with medical devices will not be significant or wide-spread if facilities take appropriate actions to address this issue. There will be specific problems that need correction; however, the current assessment is that they are much more likely to disrupt patient care rather than be of direct danger to patients."
GAO Y2K expert Joel Willemssen testified that "organizations such as FDA can provide medical device users with a greater level of confidence that their equipment is Y2K compliant through independent reviews of manufacturers' compliance test results." He said that FDA-proposed audits would meet GAO's concerns.
The Center for Devices and Radiological Health (CDRH) has issued a guidance on reporting date-related medical device problems associated with Y2K or other date issues, such as 9/9/99 and 2/29/2000. Device manufacturers are required to report a death or serious injury, whether or not the event was a result of Y2K failure. They must also file a report when they become aware of information that reasonably suggests that a device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
The guidance says that manufacturers need not report malfunctions such as failure of a device to change to the year 2000 in a recordkeeping function not likely to result in an adverse event or a device that performs properly but displays an error message such as "set clock." Similar requirements are set forth for user facilities and importers. The guidance reviews reporting exemptions available for recurring date events and says it intends to develop a separate exemption to cover Y2K events for which a manufacturer or importer takes no remedial action.
The guidance can be found at http://www.fda.gov/cdrh/postsurv/2299.html.
Device manufacturers now have another reason to visit FDA's Web site: to check out the questions the agency will ask device advisory committees in advance of panel meetings.
The innovative practice of providing such information was first seen in May, when CDRH posted two multipart questions for the Ear, Nose, and Throat Advisory Panel on its home page three weeks before for the panel met on June 18. The questions concerned "the significant issues of safety and effectiveness" of implantable middle-ear amplification devices and were part of the center's development of a guidance document for industry.
"I think it will become the norm," CDRH's Harry R. Sauberman said in commenting on the posting. "We wanted to do it to be more equitable for everyone." Device manufacturers and other interested parties can now know ahead of time what FDA's issues are and can be better informed if they want to call in for clarification before an advisory committee meets.
If the practice becomes widespread, it will go a long way toward eliminating persistent complaints that companies can be "blindsided" or "ambushed" by FDA at advisory committee meetings.
CompuMed Inc., of Manhattan Beach, CA, said in May that FDA had approved the marketing under a 510(k) of its OsteoGram 2000, an automated device to enable physicians to perform bone-density tests in their offices using their existing standard x-ray equipment. The system comprises a desktop scanner, a standard personal computer, and special software. According to company officials, the procedure involves taking an x-ray of the patient's hand and scanning it into the computer for automated analysis. Officials also reported that in a three-year study sponsored by Merck, the U.S. Public Health Service, and the Hawaii Osteoporosis Foundation, the OsteoGram outperformed competing devices in terms of osteoporosis prediction scores. It is also said to precisely measure changes in bone mass over time.
Every FDA inspector will be equipped with both a laptop computer and a portable scanner, if new FDA associate commissioner for regulatory affairs Dennis Baker has his way. Heading into his second month on the job, the former Texas state regulator remarked in May that the only thing holding him back in this objective was resources, but that he was hopeful of getting funds for such purchases in the next FDA budget, which so far is heading higher in Congress.
The laptops will enable investigators to begin each inspection with the current compliance profile of the firm, together with inspection reports not only on the facility to be inspected but on related company sites. And the scanners will save a lot of time by enabling investigators to enter product, equipment, and certain record information directly into the computers, Baker said.
Sabratek Corp. of Skokie, IL, announced in May that FDA had approved its 510(k) application for a normal saline IV flush syringe. Company officials said they had voluntarily stopped distribution of the product this past November pending 510(k) approval. The company reports that it is working with its suppliers in order to resume production and shipments to customers as quickly as possible.
DiagnoCure Inc. of Sainte-Foy, PQ, Canada, said in May it had been told that FDA needs additional information on the company's ImmunoCyt, a test for early diagnosis of bladder cancer, before the agency can act on the firm's application for approval to market the test in the United States. Company officials indicated the agency wants additional data on efficacy of the test among subjects of different races as well as on reproducibility of test results by different laboratories. They added that data on a clinical trial involving different races are being analyzed and can be submitted quickly and that laboratories have been selected for the interlab assessment. According to the company, the test has been approved in Canada and 12 other countries.
Ten voluntary standards from the American Society for Testing and Materials (ASTM) and five FDA guidance documents should together be enough to allow the reclassification of certain shoulder-joint prostheses, FDA has announced. In a May 29 Federal Register notice, FDA stated that it is reclassifying metal/polymer/metal nonconstrained or semiconstrained, porous-coated, uncemented prostheses into Class II from Class III. The agency sought public comment until last August 26 on an Orthopedic and Rehabilitation Devices Panel recommendation to down-classify these devices. The panel made its recommendation in January 1998, following review of a petition for reclassification submitted by the Orthopedic Surgical Manufacturers Association.
FDA-recommended special controls for Class II home uterine activity monitors can be found in CDRH's just-released draft guidance Home Uterine Activity Monitors: Guidance for the Submission of 510(k) Premarket Notifications. In the draft guidance, CDRH asks for results from a small clinical study showing that the device produces tracings at the receiving station that are readable. The guidance also elaborates on ways of providing a comparison with the predicate device and on cleaning and disinfecting, electrical safety testing, bench validation testing, and intended use.
The guidance can be found at http://www.fda.gov/cdrh/newpg.html.