“Corrective Fix” a Negative Connotation for Medical Device Manufacturers
04-20-2010
By Willie Bryant
The medical device industry and trade associations representing device manufacturers are expressing considerable concern about proposals and comments concerning the term “corrective fix” as defined by the FDA’s Center for Device and Radiological Health (CDRH). The term “corrective fix” suggests the need for a medical device recall even though it appears on the surface that it should not be needed. CDRH management has indicated that a manufacturer bringing a newly improved device into the marketplace would be expected to recover earlier models of that device from consignees. Medical device manufacturers whose devices fall into this category must be prepared to follow recall procedures and adhere to recall regulations throughout the process.
Since at least 1976, FDA guidance and precedent has been clear that the “correction” in place, or “removal” of a medical device from consignees, is a recall only when the device violates FDA regulations. According to the Code of Federal Regulations Part 7.40 Recall Policy, “Recall is an effective method of removing or correcting consumer products that are in violation of laws administered by the Food and Drug Administration.” A recall occurs when a medical device is defective, is a risk to health, or both. Types of FDA action that may be considered a recall include:
- Inspecting the device for problems;
- Repairing the device;
- Adjusting settings on the device;
- Re-labeling the device;
- Destroying the device;
- Notifying patients of a problem; and
- Monitoring patients for health issues.
Device manufacturers are understandably concerned that the agency would expect them to replace older devices after manufacturing and marketing an improved version. But I am not aware of any precedent for requesting or expecting such a product replacement and, at this point, the FDA has no authority to request such action. However, manufacturers bringing an improved product to market must give strong consideration to the reasons for the improvement. If the improvement was made in order to deal with any of the circumstances described above that could have resulted in a potential health hazard, the manufacturer must consider whether the older product is, in fact, subject to a recall, either for correction or removal from the market.
As long as the older device meets all specifications, is not defective, and presents no unusual or unexpected hazard, there may not be a legal justification for its removal. However, there is a precedent for removing approved products from commerce in the pharmaceutical industry. For example, Vioxx was removed from the market voluntarily by the manufacturer because unexpected post-approval data raised safety concerns. Removal of approved products that meet all specifications are classed by the FDA as “market withdrawals” rather than recalls.
Regardless of the eventual outcome of a regulatory science meeting held in February, or of any changes in recall policy that may be recommended by at CDRH internal task force charged with evaluating science practices, now is a good time to review and update your current recall plan. FDA guidance recommends that you have a recall plan in place and that it is sufficient to quickly handle any recall event that might arise, either for correction or removal. It is also good practice to test your plan periodically with a Mock Recall. And be sure to review the exercise carefully and make appropriate adjustments to your plan immediately. This may well include identifying and contacting outside resources to manage recall logistics that you find you cannot handle internally.
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[...] recently discussed on this blog concerns that the medical device industry has about FDA’s new “corrective fix” pilot program. This pilot program may require some manufacturers to recall older devices when FDA’s Center for [...]