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By Dale McGeehon The U.S. Food and Drug Administration (FDA) issued draft guidance July 9, 2013, for medical device manufacturers that proposes forma...

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|Aug 20|magazine13 min read

 

By Dale McGeehon

 

The U.S. Food and Drug Administration (FDA) issued draft guidance July 9, 2013, for medical device manufacturers that proposes formal changes to existing 1997 guidance, most notably dropping the two-year rule for malfunctions and obligations after selling a 510(k).

The changes either are new or put into writing what has been FDA practice over the last few years, say two FDA and healthcare practice attorneys with Morgan, Lewis & Bockius LLP, who summarized the guidance in an article in The National Law Review. Medical device manufacturers should carefully consider the draft guidance and determine whether they want to submit comments before the October 7, 2013, deadline, say the attorneys.

Medical Device Reports Revised

"The new draft guidance provides detailed recommendations and clarifications on manufacturers' obligations for submitting medical device reports (MDRs), maintaining MDR procedures, and related recordkeeping requirements," write the attorneys, Elizabeth Bierman and Michele Buenafe. "The draft guidance also includes sections addressing frequently asked questions and common reporting errors."

MDR regulations require manufacturers, importers, and user facilities to report significant adverse events -- such as a death or serious injury -- involving medical devices to the FDA. The manufacturers also must report to the FDA when they learn that one of their devices has malfunctioned and would likely cause or contribute to a death or serious injury if the malfunction occurred again.

Removal of Two-Year Rule on Reporting Devices Malfunctions

One of the changes involves the removal of the so-called two-year rule for malfunctions. Historically, the FDA has taken the position that if a malfunction causes a death or serious injury, future malfunctions of the same type must be reported. The existing 1997 guidance says that the presumption would cease if the malfunction did not cause or contribute to a significant event for two years.

The new draft guidance, however, says that if manufacturers want to stop reporting a malfunction that had contributed to a serious injury or a death they will need to send in a request to the FDA for an exemption. That request will need to be supported with evidence that the malfunction had not contributed to any other serious injuries or deaths.

The attorneys point out that it's not clear in the draft guidance how much data -- such as one year's or two years' worth -- would be needed support the request for the exemption. Perhaps that is what those who wish to comment on the guidance can speak about.

Changes to Contract Manufacturer Arrangements

"FDA would expect only one report from either the specifications developer or the contract manufacturer for one reportable event," says the agency in its 1997 guidance regarding contract manufacturer arrangements. "Nevertheless, there must be a written agreement which identifies which party is responsible for completing Form 3500A."

This is the form used by distributors, importers, applicants, and manufacturers to report adverse events and product problems. It is mandatory in such events.

In the past few years, the FDA has been requiring what is not stated in the 1997 guidance: that it needs an exemption when only one entity reports in a contract manufacturer arrangement. The new draft guidance puts into writing this practice. It states that both the specifications developer and contract manufacturer must submit MDR reports unless the agency issues an exemption to allow reporting by only one entity.

Obligations After Selling a 510(k)

The draft guidelines provide a clarification when a device requiring marketing certification is sold from one manufacturer to another. In such instances, manufacturers need to submit a 510(k) that demonstrates that the device to be marketed is safe and effective.

The draft guidelines say that seller of the device will remain responsible for submitting MDRs for all of the devices that it made before the sale. The requirement would be in effect even if the parties have agreed that the buyer will assume the MDR responsibility. However, FDA can grant an exemption.

Reporting Events in Scientific Articles

Manufacturers of medical devices may need to keep track of serious adverse events that are reported in scientific articles and other literature, under the new draft guidance. If those articles report adverse events, then the manufacturers may need to contact the authors and obtain additional information about those events.

The manufacturers may be allowed to describe multiple events in one report if the maker is unable to obtain sufficient information for a complete report for each reportable event. However, the draft guidance recommends that the maker submit a separate report for each event type, if multiple events are identified, and for each device, if more than one generic device type is implicated, the attorneys say.

 

About the Author

Dale McGeehon is the head blogger for Polymer Solutions Incorporated, a medical device testing lab that solves complex challenges for medical product manufacturers. Dale has been a science journalist and editor for three decades, and covers material testing on the PSI blog.