FDA report upbraids device applications

March 10, 1993

The Food and Drug Administration last week released an internalreview of the agency's medical device approval process that tookdevice manufacturers to task for submitting sloppy product approvalapplications. The review concluded that the poor quality of

The Food and Drug Administration last week released an internalreview of the agency's medical device approval process that tookdevice manufacturers to task for submitting sloppy product approvalapplications. The review concluded that the poor quality of applicationsis a factor in the ongoing gridlock of device approvals.

The Committee on Clinical Review was formed last April to reviewthe adequacy of clinical studies submitted by manufacturers tosupport premarket approval applications, investigational deviceexemptions and 510(k) applications. The committee is commonlyknown as the Temple committee, after its co-chair, Office of DrugEvaluation I director Dr. Robert Temple.

According to the Temple committee's report, some of the slowdownin the approval process could be due to deficiencies in clinicaldata submitted by manufacturers, deficiencies that were seriousenough to impede the agency's ability to review device applications.

"Applications containing deficiencies of the kind seenby the committee can require (Center for Devices and RadiologicalHealth) reviewers to spend tremendous resources bringing an applicationto an approvable state, necessitating repeated requests for additionaldata and prolonging the review period," the report concluded.

The committee recommended that manufacturers and CDRH reviewerswork more closely when studies are designed. The committee alsosuggested that a set of guidelines for study design and analysisbe developed and that advisory committees be used to improve thequality of data used in device applications.

Although some of the Temple committee's recommendations werewelcomed by the Health Industry Manufacturers Association, thedevice manufacturer group pointed out that the review was basedon an examination of only 29 applications out of the 5000 theagency reviews in a year.

BRIEFLY NOTED:

  • Advanced NMR and GE Medical strengthened their fast-MRIrelationship this week, providing the former with much-neededproduct security and a rosier business future. GE gained two-yearexclusive rights--with an option to extend--for the marketingand use of Advanced NMR's InstaScan echo-planar imaging technologyin its existing Signa MRI systems. GE will also use Advanced NMRtechnology in future Signa MRI systems if certain unspecifiedconditions are met.

Previously, GE had agreed to sell the Advanced NMR InstaScanecho-planar imaging product for use with the 1.5-tesla Signa MRIsystem and promised customers an upgrade path to future GE-developedEPI products (SCAN 12/16/92).

As part of the new agreement, GE guarantees Advanced NMR thatit will buy 100 InstaScan systems or other Advanced NMR productsby the end of next year, with delivery by the end of 1995. Thetwo companies also agreed to cooperate in future MRI-related productdevelopment.

  • ISG Technologies of Mississauga, Ontario, also signeda significant technical supply agreement with GE Medical thismonth. GE used the image processing firm's Imaging ApplicationsPlatform software development product in building applicationsfor its latest Advance positron emission tomography camera (SCAN12/16/92). The major imaging vendor will now make IAP availablefor use by its own engineers in developing software applicationsfor other modality products.

  • Lorad made progress last month in protecting its digitalmammography technology when the U.S. Patent Office allowed patentclaims related to its charge-coupled device camera. Lorad expectsthe patent to be issued in a few months.

Meanwhile Lorad nabbed a major mammography contract with theU.S. army. The Danbury, CT, subsidiary of Thermo Electron willsupply mammography and stereotactic-guided biopsy equipment foreight army hospitals. Lorad values the contract at over $1 million.It will be completed this year.

  • Cytogen acquired worldwide rights last month to the cancer-targetedmonoclonal antibody R&D program of Unipath, a medical subsidiaryof Unilever. The Princeton, NJ, biotechnology firm gains exclusiverights to five antibodies targeted at breast, colorectal and ovariantumors. Cytogen also has rights to relevant Unilever patents andtechnology, including its process for humanizing antibodies.