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Revised FDA Import Alerts
February 15, 2011 by Elizabeth Parker|FDA and EPA

The Food and Drug Administration has posted revised versions of the following Import Alerts on the detention without physical examination of:

FDA Exempts Medical Device Data Systems from Premarket Notifications
February 15, 2011 by Kelly Sly|FDA and EPA

The Food and Drug Administration is issuing a final rule, effective April 18, 2011, to reclassify Medical Device Data Systems (MDDSs) from class III (premarket approval) into class I (general controls). MDDS devices are intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. FDA is exempting MDDSs from the premarket notification requirements.

FDA Says Greater Global Food & Drug Regulation Standards Needed
February 15, 2011 by Elizabeth Parker|FDA and EPA

On January 31, 2011, the Food and Drug Administration Commissioner Hamburg gave a speech at the Council on Foreign Relations New York Symposium, stating that there should be greater cooperation and enforcement of regulatory standards internationally due to the negative implications of globalization on food and drug safety.

Revised FDA Import Alerts
February 14, 2011 by Elizabeth Parker|FDA and EPA

The Food and Drug Administration has posted revised versions of the following Import Alerts on the detention without physical examination of:

Commissioner Nord Urges Finalization of "15(j)" Drawstring Rule
February 14, 2011 by Barbara Chaves|FDA and EPA

Commissioner Nord of the Consumer Product Safety Commission issued a statement on her vote to approve a proposed civil penalty settlement for Ms. Bubbles, Inc. regarding certain children's apparel drawstring hazards. She said she voted with some reservation as she would prefer the agency to finalize its proposed "15(j)" rule on drawstrings, rather than address the risk through ad hoc enforcement.

CPSC Lists CPSIA Certificate Requirements for Its Standards, Rules & Bans
February 14, 2011 by Barbara Chaves|FDA and EPA

The Consumer Product Safety Commission has posted a chart of its rules, standards and bans, listing which Consumer Product Safety Improvement Act of 2008 (CPSIA) certification requirements apply, the dates those requirements apply, and any stays of enforcement in place for these certification requirements.