Regulatory Challenges in Biomaterials: Focus on Medical Devices - Biomaterials Science: An Integrated Clinical and Engineering Approach - page 235

develops standards for products, processes, and services that are used by
industry. Within the ASTM, the F04, or Medical and Surgical Material and
Device Committee, sets the standards in issues regarding biomaterials and
medical devices. The ASTM has developed several tests, standard specifica-
tions, and standard terminology for a wide variety of biomaterials that have
been adopted by the FDA. Among these tests are the corrosion and fatigue
test for metallic implants, an in vitro test to evaluate the hydrolytic degrada-
tion properties of polymers used in surgical implants, the standard test for
measuring magnetically induced torque in medical devices in a magnetic
resonance environment, the standard specification for unalloyed titanium
for surgical implants applications, and the standard specification for calcium
phosphate coatings for implantable materials.
With the aim to improve the safety of medical devices, the FDA has created
the Standard Management Staff (SMS) within the CDRH. The SMS is respon-
sible for the FDA Standards Program, which is in charge of adopting the
standards developed by the above-mentioned organizations. The SMS has
developed a standard database where several of the FDA recognized stan-
dards are listed divided by specific areas, including materials and devices,
thus facilitating the selection of appropriate standards by manufacturers.
The use of the recognized standards that are listed in this database could
benefit manufacturers during the regulatory process [19, 20].
Mandatory Standards
Although some standards are voluntary, other standards are adopted by reg-
ulatory agencies and become mandatory. GMP, GLP, and GCP (good manu-
facturing practices, good laboratory practices, and good clinical practices,
respectively) are examples of mandatory standards that have been agreed
upon by the International Conferences on Harmonization (ICH), an interna-
tional effort carried out by Europe, Japan, and the United States to establish
scientifically consensuated guidelines in biomedical research and develop-
ment, and adopted by regulatory agencies all over the world to ensure that
standards are followed by manufacturers during the development, labora-
tory testing, and clinical evaluation of medical products.
Good manufacturing practices (GMP) are a set of requirements including
facilities, equipment, personnel, packaging, and labeling of medical devices
that should comply with the FDA regulations according to the Code of
Federal Regulations (the Code of Federal Regulations, or CFR, is a set of
rules in a number of volumes produced by departments and agencies of the
federal government) to ensure that device manufacturing is safe and that
any chance of defects in the final product or adulteration is minimized or
avoided. FDA personnel have the authority to perform inspections at any of
the manufacturer facilities where devices are developed and inspect all the
records and documents. If the FDA finds a violation to GMP, it can halt the
production of the device for up to 30 days [16].