OPEN LETTER TO MEDICAL DEVICE MANUFACTURERS

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OPEN LETTER TO MEDICAL DEVICE MANUFACTURERS

August 31, 1997

Dear Medical Device Manufacturer

I was recently reading that the FDA is proposing to change the 510(k) requirements for the medical device industry. The FDA is proposing to allow companies to use their Design Controls Procedures of the new GMP for product modifications as the main basis for making substantial equivalence determinations. This is being called "A New 510(k) Paradigm."

To get companies to use this method, the center is going out on a limb and saying that they will complete their review of 510(k) products handled in this way in 30 days.

The FDA has stated in this proposal that "tests results generated pursuant to the new design control requirements will be sufficient to serve as a basis for certain substantial equivalence decisions."

When design control results are submitted, the center will "forgo a detailed review of underlying data normally required in 501(k)s," it promises.

This is a very interesting proposal that the FDA has decided to provide to the industry. But, does it go far enough? In 1993 an article was published in the Medical Device Executive magazine describing exactly this scenario. The article, "Make the Revise GMP Worthwhile", by me, Alan Schwartz, (copy below) provides a detailed description of how the FDA should let this very costly and most difficult implementation of the new GMPs, the Design Review Section, be made of real valuable to the industry especially the small medical device manufacturer. But why can’t the FDA take their initiative even further as I discussed several years ago. With the right regulatory environment maybe it will.

Alan P. Schwartz, Executive Vice President