Page 74 - Biomedical Engineering and Design Handbook Volume 2, Applications

FDA MEDICAL DEVICE REQUIREMENTS 53

(6) Ensuring that information related to quality problems or nonconforming product is disseminated to those
directly responsible for assuring the quality of such product or the prevention of such problems; and
(7) Submitting relevant information on identified quality problems, as well as Corrective and Preventive
Actions, for management review.
Id. § 820.100(a).

FDA file personnel look to CAPA first to see the state of your business. CAPA tells what your
problems are, how you fixed them, and the quality of your processes for finding future issues.

Subpart K: Labeling and Packaging Control. The labeling of a medical device is as important a
component as any piece of hardware. The labeling defines what the product is. Remember there is a
distinction between the label and labeling. A label is what is affixed to the product or its container.
What you stick on the box is a label. That label plus whatever instructions go to the customer, constitute
labeling. All labeling is controlled. The QSR is concerned with two major aspects of labeling: (1) is the
content correct and (2) is the correct labeling applied to the product? Labeling requirements state
(a) Label integrity. Labels shall be printed and applied so as to remain legible and affixed during the cus-
tomary conditions of processing, storage, handling, distribution, and where appropriate use.
(b) Labeling inspection. Labeling shall not be released for storage or use until a designated individual(s)
has examined the labeling for accuracy including, where applicable, the correct expiration date, con-
trol number, storage instructions, handling instructions, and any additional processing instructions.
The release, including the date and signature of the individual(s) performing the examination, shall
be documented in the DHR.
(c) Labeling storage. Each manufacturer shall store labeling in a manner that provides proper identifica-
tion and is designed to prevent mixups.
(d) Labeling operations. Each manufacturer shall control labeling and packaging operations to prevent
labeling mixups. The label and labeling used for each production unit, lot, or batch shall be docu-
mented in the DHR.
(e) Control number. Where a control number is required by 820.65, that control number shall be on or
shall accompany the device through distribution.
Id. § 820.120.

Labeling errors result in many recalls of product. Putting the wrong label on a box or inserting
the wrong instructions-for-use in a box is a simple human error. It can, however, result in risk to
patients and interference with the provision of medical care. FDA investigators look to see if your
labeling and labels are carefully sorted and marked to prevent incorrect application. They also com-
monly look for crowded or poorly laid out labeling stations that confuse the personnel and increase
the risk of error.
Subpart L: Handling, Storage, Distribution, and Installation. While the handling and storage
provisions of this subpart apply to all processes, the most significant thing in the subpart is the exten-
sion of the QSR all the way through manufacturing to distribution.
Handling procedures must be in place throughout your system for preventing “mixups, damage,
∗
deterioration, contamination or other adverse effects.” You must also have adequate storage at all
steps along the manufacturing process to prevent these errors. †
Your distribution must be under a controlled procedure that ensures that goods which have dete-
‡
riorated or are beyond their shelf-life are not distributed. You must also keep records of
(1) The name and address of the initial consignee;
(2) The identification and quantity of devices shipped;

∗
Id. § 820.140.
†
Id. § 820.150
‡
Id. § 820.160(a).