켐론FDA코리아

August 13, 2012

Dear Registered Establishment,

The FDA has issued Draft Guidance for Industry and Food and Drug Administration Staff - Refuse to Accept Policy for 510(k)s. This guidance explains the procedures and criteria FDA intends to use in assessing whether a 510(k) submission is administratively complete and should be accepted for substantive review.

The draft guidance modifies the existing “Refuse to Accept Policy for 510(k)s” to include an early review against specific acceptance criteria and to inform the submitter within the first 15 calendar days of receipt of the submission if the submission is sufficiently complete to allow a substantive review, or if not, to identify the missing element(s). [ 510(k)s submission시 자료가 충분하여 실질적 심사가 가능할 경우, 또는 자료가 불충분하여 심사가 불가능할 경우에는 Submission의 Receipt을 받은 후 15일 이내에 submitter에게 통지하도록 “Refuse to Accept Policy for 510(k)s”의 Draft Guidance를 변경하였습니다. ]

This guidance clarifies the necessary elements and contents of a complete 510(k) submission. The elements and contents outlined are applicable to all devices reviewed through the 510(k) notification process in CDRH and CBER and have been compiled into checklists for use by FDA review staff.

You may submit comments and suggestions regarding this draft document within 45 days. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.

For more information, please see http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM315014.pdf.

Thank you,

Center for Devices and Radiological Health

Food and Drug Administration