Biomedical Engineering Reference
In-Depth Information
An
investigational device exemption
(IDE) application (refer 21 CFR 812
for more details) required for many companies to continue forward with a
clinical trial, particularly for devices that pose a significant risk to patients
participating in a clinical trial. IDE approval allows a company that would
otherwise be subject to premarket approval to ship the device for the purpose
of conducting a clinical trial.
A
humanitarian device exemption
(HDE) application if the device qualifies
under this category, which is determined by the absence of a comparable
device available to treat or diagnose the disease or condition. Institutional
review board (IRB) approval is necessary prior to usage and for the FDA-
approved indication.
Product Development Protocol (PDP)
for class III devices with significant
literature data and the existence of recognized protocols.
11.5.3 Compliance Requirements
For the medical device industry, documenting new product development activities
from concept, design, and manufacturing to sales and distribution in a controlled
manner is detailed in the quality system regulation (QSR) 21 of the Code of Federal
Regulations (CFR) 820. The FDA also publishes guidance documents intended to
state the current thinking on a topic to manufacturers and FDA reviewers. Guid-
ance documents are written by FDA staff and specify what the FDA believes will as-
sist in the determination of safety and effectiveness. However, guidance documents
do not create or confer any rights for or on any person and do not operate to bind
the FDA or the public. Alternative approaches can be used as long as applicable
statutes and regulations are satisfied. Recognizing the important role of informa-
tion technology, the FDA issued regulations regarding the use of electronic records
and electronic signatures (21 CFR Part 11) [8]. 21 CFR part 11 provides basic
principles for the use of electronic records and electronic signatures in complying
with other FDA regulations, specifically where record keeping, documentation, or
authorization is specified. In the context of 21 CFR part 11, FDA regulations such
as those concerning manufacturing practices, laboratory practices, adverse event
reporting, and product tracking are referred to by the agency as predicate rules.
Whenever a company chooses to comply with predicate rules by means of electronic
records or electronic signatures, 21 CFR part 11 must be followed. Manufacturers
must be certain that the computer systems they use to replace paperwork are at least
as effective in complying with FDA regulations.
A quality system is meant to establish the ways in which the company will
comply with applicable regulations. The documents are developed specifically for
the ways in which manufacturers actually do business. In practice, these documents
consist of a quality manual, standard operating procedures (SOPs), forms, audit
records of suppliers, and training files, and describe the procedures to follow in
order to comply with the regulations. The design process is a good illustration of an
operation that requires quality system documents. Different SOPs may be required
for varying operations. If someone is making an engineering drawing or creating a
prototype, an SOP for design controls is required. Design control records must be
