Page 75 - Biomedical Engineering and Design Handbook Volume 2, Applications

54 MEDICAL DEVICE DESIGN

(3) The date shipped; and
(4) Any control number(s) used.
Id. § 820.160(b).

∗
If you perform installation of your product, you must establish procedures for installation. This
continues the QSR right into your customer location.
Subpart M: Records. Since records are the lifeblood of a quality system, this subpart contains some
important issues. It defines that records must be legible and accessible, including for FDA inspectors.
This can be an issue if you are using paper records. If your manufacturing is not done at the same
location as design, you may have difficulty having all applicable records available for inspection. The
modern era of electronic systems prevents this by having one record, accessible by all.
This subpart also contains the statement that you can mark these records as confidential, limiting
FDA’s release of them to the public. Virtually all QSR records should be marked as confidential.
Records under the QSR must be kept for the expected life of the device, but in no case less than
2 years after commercial release.
Important exceptions to FDA’s access to QSR records are “reports required by 820.20(c)
Management review, 820.22 Quality audits, and supplier audit reports used to meet the requirements
of 820.50(a) Evaluation of suppliers, contractors, and consultants.” FDA wants to encourage robust
†
internal questioning of your quality system. FDA’s inspection of these records could cause hesitancy
to be forthright. Therefore they are placed off-limits for FDA investigators. Once a legal proceeding
begins, however, this limitation is no longer in effect.
This subpart defines a few of the most important QSR records, such as the device master record,
the device history record, and the quality system record. The most important definition is the section
on complaint files. A complaint is

any written, electronic, or oral communication that alleges deficiencies related to the identity, quality,
durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.
Id.§ 820.3(b).

A manufacturer must maintain complaint files, along with a procedure that ensures they are
processed in a timely manner, documented even if oral, and evaluated to see if they must be reported
as Medical Device Reports (see the following paragraph). Then each complaint must be evaluated to
determine whether an investigation is necessary. Such an investigation must be done if there is a
possible failure of the device, labeling or packaging to meet specification. ‡
Complaints usually are put into the CAPA system when investigation is needed. A record of the
investigation must include
(1) The name of the device;
(2) The date the complaint was received;
(3) Any device identification(s) and control number(s) used;
(4) The name, address, and phone number of the complainant;
(5) The nature and details of the complaint;
(6) The dates and results of the investigation;
(7) Any corrective action taken; and
(8) Any reply to the complainant.
Id. § 820.198(e).

* Id. § 820.170.
† Id. § 820.180(c).
‡ Id. § 820.198.