新闻中心

FDA启动对诊断用X光设备的美国本土和美国境外制造商的为期3年的验厂程序

2008年5月15日消息，FDA启动对诊断用X光设备的美国本土和美国境外制造商的验厂程序，计划开始实施日期为2008年6月1日，计划结束日期为2011年6月1日，为期3年。涉及产品范围广泛。请国内制造商注意了解相关的信息并及时做出应对准备。

http://www.fda.gov/cdrh/ocer/guidance/7386.003a.html

Inspection of Domestic and Foreign Manufacturers of Diagnostic X Ray Equipment

Program 7386.003a CHAPTER 86 MEDICAL AND RADIOLOGICAL DEVICE MONITORING AND QUALITY CONFORMANCE

详细信息请访问FDA官方网站：

http://www.fda.gov/cdrh/ocer/guidance/7386.003a.html

FIELD REPORTING REQUIREMENTS

• Submit copies of all Establishment Inspection Reports (EIRs) and field test reports, attachments, exhibits, correspondence between the district and firm, and other documentation to:

Center for Devices and Radiological Health
Office of Communication, Education and Radiation Programs
ATTN: Diagnostic Devices Branch (HFZ-240)
1350 Piccard Dr .
Rockville MD 20850

Original documents are maintained by the home district.

• Copies of the EIRs and field test reports, attachments, exhibits, correspondence between the district and firm and other documentation should be routed to appropriate Radiological Health staff, as identified in Part VI of this program, to the accomplishing district and to the district where the firm is located (if located in a different district from the accomplishing district).

• All FACTS data should be entered by the accomplishing district where the operation was performed.

This document represents the agency’s current thinking on the enforcement of the Federal Food Drug and Cosmetic Act Electronic Product Radiation Control provisions and related regulations. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.

FACTS

·   All FACTS data should be entered by the investigator of record.

·   Comprehensive inspections are reported in FACTS for manufacturing plants producing certified diagnostic radiation-emitting electronic products on a recurring basis.

·   If the firm is not manufacturing or has not introduced any products into commerce, this time should be reported as investigations. Report all time spent for telephone calls and reviewing documentation that do not lead to on-site inspections under Operations Code 13 "Domestic investigations".

·   Report time spent on operations leading to on-site inspections of manufacturers as below;

o      Domestic inspections – use OP Code 12

o      Foreign inspections – use OP Code 11

·   Any training related to this program should be reported as below;

o      Training received – use OP Code 84

o      Training given – use OP Code 83

Attachment A: DIAGNOSTIC X-RAY PRODUCT CODES 涉及到的产品信息

详细信息请访问FDA官方网站：

http://www.fda.gov/cdrh/ocer/guidance/7386.003a.html

IRC编译整理

www.FDAChina.com