Obtaining Regulatory Approval to Market - Medical Device Design: Innovation from Concept to Market - page 312

Table 14.2: Medical Specialty Codes

Medical Specialty (Advisory Committee) Regulation No. Medical Specialty Code

Anesthesiology Part 868 AN

Cardiovascular Part 870 CV

Clinical Chemistry Part 862 CH

Dental Part 872 DE

Ear, Nose, & Throat Part 874 EN

Gastroenterology & Urology Part 876 GU

General Hospital Part 880 HO

Hematology Part 864 HE

Immunology Part 866 IM

Microbiology Part 866 MI

Neurology Part 882 NE

Obstetrics/Gynecology Part 884 OB

Ophthalmic Part 886 OP

Orthopedic Part 888 OR

Pathology Part 864 PA

Physical Medicine Part 890 PM

Radiology Part 892 RA

General & Plastic Surgery Part 878 SU

Clinical Toxicology Part 862 TX

As with the EC registration, this is self-certification - you are certifying that you have done
everything required. More fool you if you have not. FDA inspectors are Federal Marshals:
they are not to be treated lightly!

14.3 Higher Classifications
Unfortunately the processes of the USA and the EC are now as different as chalk and cheese.
Neither is a precursor to the other. Success in one does not automatically lead to success in
the other. Both systems are wholly different. However, the saving grace is that the information
you need for both is virtually identical: it is the way it is presented that differs. The FDA
process is a paperwork process. The EC process is an audit-based process.

14.4 FDA Process
The 510(k) process is, arguably, easier to undertake: hence we shall look at this first. You will
need to register your establishment as described in the previous section. Nothing can happen
until that expense has been undertaken. However, before you progress further you should
confirm if your company is classed as a small company in FDA eyes. If so, most of the future
application fees are much reduced. Hence it is worth undertaking a quick trip onto the FDA
website and seeking out the most current rules.