Page 70 - Biomedical Engineering and Design Handbook Volume 2, Applications

FDA MEDICAL DEVICE REQUIREMENTS 49

Subpart G includes a list of requirements that look very broad and general. These are interpreted
by FDA to require a company to use what is viewed as the current standard of care in the industry.
That is, the requirements grow and change as technology advances. Among the requirements are
• Environmental control—The manufacturer must control environmental conditions that could
affect product quality. This includes inspecting and verifying that the equipment is adequate and
functioning properly.
• Personnel—You need requirements for the health, cleanliness, personal practices, and clothing of
personnel if they can affect product quality.
• Contamination—You need to prevent contamination of equipment or product.
• Buildings—Buildings must be suitable for manufacturing your product and must contain suffi-
cient space to manufacture without mix-ups.
• Equipment—Your equipment must meet process specifications and must be designed, constructed,
placed, and installed to facilitate maintenance, adjustment, cleaning, and use.
• Maintenance schedule—You need documented schedules for adjustment, cleaning, and other
maintenance of equipment.
• Inspection—There must be scheduled periodic inspections to ensure that maintenance has been
done according to procedure.
• Adjustment—Limitations or allowable tolerances must be posted on equipment that requires
periodic adjustment.
• Manufacturing material—Any manufacturing material that could negatively affect product quality
must be removed from the manufacturing area.
• Automated processes—Any software used in computers or automated processing must be vali-
dated. Any changes must be validated before implementation.

While these requirements may look general, there is a whole history of industry meaning built
into every one. Most of these requirements vary with the complexity of the device being manufac-
tured and the risk to the end user. Great flexibility is built into the QSR so that manufacturers may
develop processes appropriate to the product. The QSR is a little more precise and prescriptive when
it comes to calibration:

Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical,
automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable
of producing valid results. Each manufacturer shall establish and maintain procedures to ensure that equip-
ment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions
for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained.
Id. § 820.72(a).

There must be
• Calibration procedures that set limits for accuracy and precision, along with remedial action to
be taken if the equipment is out of calibration.
• Calibration standards must be derived from accepted national or international standards.
• Calibration records must be near the equipment so that the current state of calibration is readily
available.
∗
Finally, this subpart requires either verification or validation of processes. As discussed above, the
terms verification and validation can have different meanings in different contexts. The definitions
show the way in which the two terms are used in the different contexts. Verification is defined as

∗
Id. § 820.75