Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
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...
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Regulatory News In Brief
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...
PMA filing checklist
Financial disclosure requirements for clinical investigators (21 CFR 54) must be met for CDRH to file a premarket application, updated "1Checklist for Filing Decision for PMAs" specifies. Posted on the agency's website Jan. 24, the document also notes that environmental assessment under 21 CFR 25.20(n) is limited to first of a kind devices. Copies of key articles referenced in bibliographic sections should be submitted to FDA in English...
TC-210 Strives To Compose Harmonized QS Device Guidance In Timely Manner
ISO 14969:1999 is expected to be revised and issued as a stand-alone technical specification document as a result of the changes that were made in the updated ISO 9000 family of standards.