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510(k) Route to Market Under New Attack
Two new pointers to the inadequacy of Sec.
510(k) to protect public health and safety emerged last week in a New York Times exposé of vaginal sling toxicity and new medical literature reporting elevated safety issues with new
ophthalmic lasers. Both devices, substantially different from the “predicate” devices they referenced in their
“substantially equivalent” 510(k) submissions to FDA, are now the subjects of liability or malpractice lawsuits.
They add to a growing list of earlier examples of problems with 510(k) reviews in CDRH that cited other devices and are
currently under Congressional scrutiny. One, ReGen Biologics’ Menaflex, is the focus of an internal FDA re-examination ordered by acting commissioner Joshua
Sharfstein.
FDA’s current advice on what makes a device “substantially equivalent” relies on whether, “in comparison to a predicate, it: - has the same intended use as the predicate; and
- has the same technological characteristics as the predicate;
or - has the same intended use as the predicate; and
- has different technological characteristics
and the information submitted to FDA;
- does not raise new questions of safety and effectiveness; and
- demonstrates that the device is at least as safe and effective as the
legally marketed device.”
In practice, a predicate can be a device that has been marketed for so short a period of time it has not established
a meaningful safety record, and it can be a part of a string of such predicates.
The New York Times exposé cited adverse reactions
leading to repeated surgeries for women using Mentor Corp.’s ObTape internally to control urinary leaks. The device
was approved under a 510(k) that asserted it was “substantially equivalent” to older products, Johnson & Johnson’s
Tension Free Vaginal Tape System and American Medical Systems’ Sparc Sling System which were themselves, in turn, 510(k)’d
as “substantially equivalent” to J&J’s Protegen sling, recalled in 1999 and described by FDA then as
“adulterated and misbranded.” The newspaper recounted life-altering miseries characterized
by persistent, painful and often bloody vaginal discharges, fear of cancer and a feeling that “I’m stuck with
this for the rest of my life.”
In the ophthalmic lasers
example, injured LASIK patients circulated on the Internet a Journal of Cataract & Refractive Surgery editorial by William J. Dupps, Jr. that commented on a University of Toronto clinical study of 149 eyes treated with a 15kHz Intralase
femtosecond laser in which 56% were associated with an adverse event called opaque bubble layer (OBL). New-generation lasers
with higher pulse frequencies may be less likely to cause OBL, Dupps said. All these devices entered the market through 510(k)
clearances. Although OBL only rarely impacts visual acuity at three months post-procedure, it is part of a growing number
of “a new array of complications” with femtosecond lasers, which are used to bladelessly create corneal flaps
preparatory to LASIK reshaping. According to injured patients, these include corrugated corneal stromal bed, extreme light
sensitivity, partial flaps, rainbow glare, torn flap, vertical gas breakthrough, epithelial ingrowth, flap necrosis, diffuse
lamellar keratitis (DLK), corneal perforation, incomplete flap, decentered flaps, small flaps, slipped flaps, flap folds,
traumatic flap dislocation, gas bubbles in the anterior chamber, optic nerve damage, flap tears, haze, macular hemorrhage,
infection, stromal cell necrosis, inflammation, keratocyte cell death, corneal nerve damage, goblet cell reduction, and interface
particles.
The Intralase devices were cleared on the basis of their “substantial equivalence” to a string of six
other Intralase 510(k)’d predicates going back to 1999. The study Dupps
cited concluded that OBL was associated with thicker corneas and smaller corneal flaps and “did not seem to have detrimental
long-term sequelae, although a small harmful effect could not be ruled out.” (READ THE FULL REPORT AT www.fdaweb.com) This complimentary article is provided by FDA Webview (www.fdaweb.com) — the Internet's leading FDA news and information site for regulated industry.
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