Beruflich Dokumente
Kultur Dokumente
OTHER
STAMP HERE
Table of Contents
1.0 Purpose..........................................................................................................................................................3
2.0 Scope.............................................................................................................................................................3
4.0 References.....................................................................................................................................................4
1.0 Purpose
To create a method for the correction or removal of a marketed product.
2.0 Scope
This procedure pertains to the correction or removal of all marketed products manufactured at the
facilities of [COMPANY NAME].
3.1 Recall
The correction or removal by [COMPANY NAME] of a marketed product which has a reasonable
probability of causing serious adverse health consequences or death, or a product which is in
violation of the laws administered by the Food and Drug Administration and would be subject to
legal action, such as seizure, by the FDA. Recall does not include a market withdrawal or a stock
recovery.
3.2 Removal
The physical removal of a product from its point of use to some other location for repair,
modification, adjustment, relabeling, destruction, or inspection.
3.3 Correction
Repair, modification, adjustment, relabeling, destruction, or inspection (including patient
monitoring) of a product without its physical removal from its point of use to some other
location.
3.4 FDA
US Federal Food and Drug Administration.
3.14.1 Class I
A situation in which there is a reasonable probability that the use of, or exposure to, the
product will cause serious adverse health consequences or death.
3.14.2 Class 11
A situation in which use of, or exposure to, the product may cause temporary or
medically reversible adverse health consequences or where the probability of serious
adverse health consequences is remote.
3.15 Consignee
Any person or firm that has received, purchased, or used the product. Consignee does not mean
lay individuals or patients, i.e., nonhealth professionals.
4.0 References
Marketed Product Correction/Removal Form
Vigilance System Final Report
Vigilance System Initial Incident Report
Enforcement Policy
Medical Device Corrections And Removals
Medical Device Recall Authority
Methods for Conducting Recall Effectiveness Checks, FDA Guidance
Active Implantable Medical Devices Directive
Medical Devices Directive
The Medical Devices Vigilance System, a European Commission Guidelines
For medical devices marketed in the European Community under the “CE” mark, in addition to the
requirements of this section (Section 6), a voluntary correction or removal must also comply with the
Medical Devices Vigilance system (Section 8).
This section (Section 6) is based on the requirements in 21 CFR Part 7, but is applicable to the
voluntary correction or removal of any marketed [COMPANY NAME] product, even if the FDA does
not regulate the product.
A correction or removal of [COMPANY NAME] marketed product begun and finalized by [COMPANY
NAME] is considered voluntary unless an order is received from a regulatory agency mandating the
action. A correction or removal recommended or suggested by a regulatory agency, but initiated by
[COMPANY NAME], is still considered voluntary. If at any time prior to or during a chosen correction
or removal, an order is received from a regulatory agency mandating the action, the action becomes
compulsory. See Section 7. Mandatory Actions.
Does the product present a health hazard, and if so, to what degree?
Is the product in violation of regulatory agency requirements, and if so, are violations
considered major or minor?
How many units of product have the problem, and where are those units in the distribution
chain?
6.3.4 Logistics
The strategy will also speak to such questions as: who, when, where, and how will the
correction or removal be performed; is correction, removal, or a combination of
correction and removal appropriate; availability of replacement units; etc.
6.4.1 Communications
[COMPANY NAME] will notify all consignees via verified written communication of
the correction or removal action. The written communication will be clearly marked
with the action type (correction, removal, recall, advisory, etc.), and will:
Be brief and to the point (no irrelevant information that may detract from the
message)
Clearly identify the product, including lot and serial numbers, and description
State the action, explain the reason for the action, and any health hazard
Provide specific instructions for product disposition
Provide a ready means of verifying to [COMPANY NAME] that the
communication was received (self addressed postcard, collect call, etc.)
If appropriate, provide instructions regarding extent of action (i.e. does strategy
require consignee to notify customers of action?)
The preparation and submission, if required, of status reports will cease when the correction or
notification is terminated.
6.7 Termination
When objectives of the correction or removal strategy have been met, and required actions
are complete, the correction or removal action should be terminated.
If regulatory agency concurrence is required for termination, a letter stating that the action
was effective, and including the last status report and the disposition of product, should be
sent to the appropriate regulatory agency office requesting termination.
If the regulatory agency concurs in writing, the action is
terminated.
If the regulatory agency does not concur, continue the
correction or removal action and address specific agency
concerns.
If concurrence from a regulatory agency is not required for termination, record the decision
to terminate in a letter to file, and terminate the action.
Products marketed outside of the USA also may be subject to mandatory actions by the countries in
which the products are sold. For medical devices marketed in the European Community under the “CE”
mark, in addition to the requirements of this section (Section 7, Mandatory Actions), must comply with
the Medical Devices Vigilance system (Section 8, Medical Devices Vigilance System).
For any mandatory action, [COMPANY NAME] will without delay comply with the action, appeal the
action if appropriate, complete requirements of the action, and have the action terminated.
The requirements of the Medical Devices Vigilance system are stated in Article 8 of the Active
Implantable Medical Devices Directive (90/385/EEC), and in Article 10 of the Medical Devices
Directive (93/42/EEC). Additional guidance is available in The Medical Devices Vigilance System, a
European Commission Guidelines.
To comply with the requirements of the Medical Devices Vigilance system consult the Directives and
Guidance for details. Use the Vigilance System Initial Incident Report form and the Vigilance System
Final Report form for filing the initial and final reports, respectively, with the appropriate Competent
Authority.