FDA'a latest bulletin
Just received by e-mail................................
Device and Diagnostics Manufacturers Will Need Different Quality Systems
for U.S. and International Markets
The FDA’s Devices Center has said that it does not intend to update its Quality System Regulation (QSR) to match coming changes in international quality standards. If the QSR is not harmonized with international standards, manufacturers will have to implement different standards for products sold in the U.S. and those marketed in the rest of the world.
The International Organization for Standardization (ISO) is updating its medical device quality standard, which takes effect in November 2003 as ISO 13485-2003. The European Union (E.U.) will also revise its medical device directive within the next two to three years. In the interim, E.U. authorities will recognize ISO 13485-2003. There are enough differences between the QSR and ISO 13485-2003 that manufacturers will need to establish quality systems that meet both sets of requirements.
These developments mean new regulatory obstacles could hinder your ability to drive products to market and keep them there. Find out how you can accommodate the latest requirements with The GMP Letter. Each month, it delivers in-depth analysis of trends in regulatory development and enforcement for medical device and diagnostics manufacturers. Each issue of The GMP Letter also reviews actual warning letters, recalls, EIRs and 483s, so you’ll learn what areas FDA inspectors are scrutinizing
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The FDA has jurisdiction on frames, lenses and all products that go on them.
Device and Diagnostics Manufacturers Will Need Different Quality Systems
for U.S. and International Markets
The FDA’s Devices Center has said that it does not intend to update its Quality System Regulation (QSR) to match coming changes in international quality standards. If the QSR is not harmonized with international standards, manufacturers will have to implement different standards for products sold in the U.S. and those marketed in the rest of the world.
The International Organization for Standardization (ISO) is updating its medical device quality standard, which takes effect in November 2003 as ISO 13485-2003. The European Union (E.U.) will also revise its medical device directive within the next two to three years. In the interim, E.U. authorities will recognize ISO 13485-2003. There are enough differences between the QSR and ISO 13485-2003 that manufacturers will need to establish quality systems that meet both sets of requirements.
These developments mean new regulatory obstacles could hinder your ability to drive products to market and keep them there. Find out how you can accommodate the latest requirements with The GMP Letter. Each month, it delivers in-depth analysis of trends in regulatory development and enforcement for medical device and diagnostics manufacturers. Each issue of The GMP Letter also reviews actual warning letters, recalls, EIRs and 483s, so you’ll learn what areas FDA inspectors are scrutinizing
---------------------------------------------------------
The FDA has jurisdiction on frames, lenses and all products that go on them.
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