ROCKVILLE, Md., Jan. 15 /PRNewswire/ -- FDA's Center for Devices and
Radiological Health (CDRH) premarket review program met all of its goals for
fiscal year 1998 (FY 98), which covers the period of October 1, 1997 to
September 30, 1998. The Center, which does not receive any user fees,
continued to make improvements over previous years' review of medical devices.
During FY 98, CDRH maintained for the second year in a row a "zero"
backlog of premarket approval applications (PMAs) for novel devices, PMA
supplements, and 510(k)s, submissions for products similar to others already
marketed.
CDRH approved 46 PMAs in FY 98, 11 of which represented important
diagnostic or therapeutic advances, and four were Humanitarian Device
Exemption (HDE) PMAs for so-called "orphan" devices manufactured for the
benefit of fewer than 4,000 patients.
Management initiatives that had been tested in pilots were implemented
throughout the Center's premarket review program. Communication with industry
continued to improve, with more companies taking advantage of the
opportunities to consult with FDA while planning clinical studies.
These factors contributed to further reductions in the Center's review
times. The average time from submission to approval for PMAs in FY 98 was 12.4
months, 25% less than the average review time of 16.6 months in FY 97 and 50%
less than the average of 25.9 months in FY 96. The median total time to
approval in 1998 was just 8.7 months.
This year CDRH had the shortest review time for any substantial number of
PMAs in a decade. Of the PMAs approved in the past fiscal year, 33% (15 of 46)
were approved in less than 180 days, and 63% (29 of 46) were approved in less
than 1 year. Furthermore, 28 of the 46 PMAs were never overdue in any review
cycle.
For 510(k) applications, the average total review time was 114 days, an
improvement over the average 130 days in FY 97 and 145 days in FY 96. This
translates to 59% of 510(k) reviews completed within 90 days, compared to 58%
in FY 97 and 50% in FY 96.
The median review time for 510(k)s cleared in FY 98 was 83 days. About 98
percent of medical devices marketed in the United States are 510(k) products,
which are similar to already existing devices.
In addition to the new devices cited in the FDA's Report on New Health
Care Products in 1998, CDRH approved in FY 98 the following significant PMA
products:
Two devices to evaluate an antigen produced by some breast cancer cells.
The results of the test are used to determine cancer prognosis of the patient
and take appropriate preventive measures.
* A thermal balloon system for treating women with uterine bleeding
disorders.
* A device to treat chronic, full-thickness skin ulcers that have not
responded to conventional therapy.
The following devices were approved under HDE PMAs:
* A finger joint replacement for people who have had implant failures
or for whom available alternatives would be unsatisfactory because they
work with their hands.
* A bladder stimulation device for children with neurogenic bladder
disorders as a result of spina bifida.
* A coronary bypass graft for people who don't have enough vessels
suitable for grafting.
* A device for hemophiliacs which lowers the levels of inhibitors of
factor XIII or IX, so that patients can resume receiving routine
clotting factor replacement.
The complete list of CDRH's 46 PMAs and HDEs approved in FY 98 is as
follows:
Coronary stent
Tissue heart valve
Replacement heart valve
Pacemaker lead removal device
Thermal balloon endometrial ablation therapy
UV-absorbing hydrophilic posterior chamber intraocular lens
Coronary stent
Fluorescence in situ hybridization DNA probe assay for qualitative
detection of HER-2/neu genomic sequences in human breast tissue
Pacing lead
Implantable pacemaker pulse generator
Percutaneous transluminal coronary angioplasty
Free prostate specific antigen, immunological test system for the
detection of prostate cancer
Ultrasound bone sonometer
Human alpha fetoprotein (AFP) assay
Contact lens cleansing solution
Rigid gas permeable contact lens solution
Salivary biochemical marker for risk assessment of spontaneous preterm
labor and preterm delivery
Rigid gas permeable contact lens solution
Interactive wound dressing
Peridural fibrosis inhibitor
Transurethral microwave thermotherapy
Ultrasound bone sonometer
SOURCE Food and Drug Administration
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