s**********8
发帖数: 25265 | 1 In fiscal year 2013, FDA’s Center for Devices and Radiological Health (CDRH
) issued 217 Warning Letters, seven more than the center issued in FY12. EAS
reviewed a total of 105 of the warning letters issued to manufacturers or
other establishments that market medical devices in the U.S. The following
were the Top 10 observations noted in those letters:
1. 21 CFR 803.17 - Failure to develop, maintain, and implement written
Medical Device Reporting procedures.
2.21 CFR 820.22 - Failure to establish procedures for quality audits and
conduct such audits to assure that the quality system is in compliance with
the established quality system requirements and to determine the
effectiveness of the quality system.
3.21 CFR 820.30(i) - Failure to establish and maintain procedures for the
identification, documentation, validation or, where appropriate,
verification, review, and approval of design changes.
4.21 CFR 820.50 - Failure to establish and maintain procedures to ensure all
purchased or otherwise received product and services conform to specified
requirements.
5.21 CFR 820.75(a) - Failure to ensure that when the results of a process
cannot be fully verified by subsequent inspection and testing, the process
shall be validated with a high degree of assurance and approved according to
established procedure.
6.21 CFR 820.90(a) - Failure to establish and maintain procedures to control
product that does not conform to specified requirements.
7.21 CFR 820.100(a) - Failure to establish and maintain procedures for
implementing corrective and preventive action.
8.21 CFR 820.181 - Failure to maintain adequate device master records (DMRs)
.
9.21 CFR 820.184 - Failure of the device history record to demonstrate the
device was manufactured in accordance with the Quality System Regulations.
10.21 CFR 820.198(a) - Failure to maintain complaint files and establish and
maintain procedures for receiving, reviewing, and evaluating complaints by
a formally designated unit. | c**a
发帖数: 98 | 2 another top reason...
Failure to submit responses for 483 form within 15 working days. | s**********8
发帖数: 25265 | 3 haha
【在 c**a 的大作中提到】
: another top reason...
: Failure to submit responses for 483 form within 15 working days.
| n*******n
发帖数: 515 | 4 为什么只分析了一百多个，qms是warning letter最大的原因，但究竟有多少wl，比例
是多少。803里的reporting是指mdr还是field action/recall reporting。。。
CDRH
EAS
with
【在 s**********8 的大作中提到】
: In fiscal year 2013, FDA’s Center for Devices and Radiological Health (CDRH
: ) issued 217 Warning Letters, seven more than the center issued in FY12. EAS
: reviewed a total of 105 of the warning letters issued to manufacturers or
: other establishments that market medical devices in the U.S. The following
: were the Top 10 observations noted in those letters:
: 1. 21 CFR 803.17 - Failure to develop, maintain, and implement written
: Medical Device Reporting procedures.
: 2.21 CFR 820.22 - Failure to establish procedures for quality audits and
: conduct such audits to assure that the quality system is in compliance with
: the established quality system requirements and to determine the
| s**********8
发帖数: 25265 | 5 MDR i guess
【在 n*******n 的大作中提到】
: 为什么只分析了一百多个，qms是warning letter最大的原因，但究竟有多少wl，比例
: 是多少。803里的reporting是指mdr还是field action/recall reporting。。。
:
: CDRH
: EAS
: with
|
|
