Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
FDA export rule stayed: Agency will delay implementation of the final rule on export notification and recordkeeping requirements until June 19, according to a 1May 14 Federal Register notice. Issued in December 2001, the rule was scheduled to take effect in March (2"The Gray Sheet" Dec. 24, 2001, p 4). Three petitions and one letter stating that "certain parties would be unable to comply by the original March 19 effective date and that some parties were confused as to the final rule's applicability to certain products," prompted the agency's decision to stay the rule. The rule implements provisions of FDA's Export Reform & Enhancement Act of 1996...
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Regulatory News In Brief
FDAMA six-year rule: Provision allowing information from a PMA submission, six years after approval, to be applied in support of other PMA decisions "conceivably...could be used in biocompatibility" tests, CDRH Director David Feigal notes at a Jan. 31 National Forum on Biomedical Imaging in Oncology meeting. Safety and effectiveness data from six-year-old PMAs may be "sort of like an automatic cross reference," Feigal said. The option will be available in two years...
FDA Final Export Rule Adds U.S. Corporate Official Certification Option
Notification and recordkeeping requirements for exporters of unapproved devices and biologicals under sections 801 or 802 of the FD&C Act will allow U.S. corporate officials at the executive-VP level and higher to certify that products do not conflict with foreign laws, according to FDA
ENDOSSEOUS BLADE IMPLANTS SHOULD REMAIN IN CLASS III, FDA PANEL SAYS; AGENCY OPEN TO FUTURE DOWNCLASSIFICATION; ROOT FORM IMPLANTS, ABUTMENTS TO CLASS II
FDA is open to receiving additional data to support the downclassification of blade-type endosseous implants and is not planning to call for premarket approval applications for the devices in the near future, agency staffers say. Blade implants are the only type of endosseous devices that FDA should keep in Class III, FDA's Dental Products Advisory Panel recommended at a Jan. 13 meeting in Rockville, Maryland.