Originally Published MDDI December
2004
Medtech
Snapshot
Manufacturing
Manufacturers: Fewer but Stronger
Medical device manufacturing appears to be healthy. The charts on these pages
indicate that the industry is indeed strong, with only slight decreases in the
number of manufacturers.
The number of FDA-registered medical device establishments decreased just 12%
from 2003 (12,560) to 2004 (11,071). Bryan Benesch in FDA’s Office of Compliance
says a significant source of the decrease is related to database cleanup. He
notes, however, that some of the decrease is attributable to companies that
in the last year have gone out of business.
If the annual registration form is returned as undeliverable by the post office,
CDRH researches the status to determine whether the establishment is no longer
in business. “We have done a significant database cleanup of these types
of records in the last year,” says Benesch.
The only major change was in the number of FDA-registered rebuilders and refurbishers,
which declined from 416 to 10. According to Benesch, the decrease is primarily
the result of the agency cleaning up its files. “These establishment types
are not required to be registered, and we have been canceling their registrations,”
he explains.
The percentage breakdown of manufacturers remained steady across the nation.
The number of manufacturers decreased fairly evenly nationwide (only Oregon
and New Mexico increased, and Idaho and Louisiana remained the same as in 2003).
In September 2004, CDRH hired a new contractor to process registration and listing
submissions. The phone and fax numbers have changed. The new contractor can
be reached by phone at 240/276-0111; fax: 301/527-9187, or e-mail at reglist@cdrh.fda.gov.
For policy questions, contact CDRH at 240/276-0110; fax 240/276-0140; or e-mail
rlprogram@cdrh.fda.gov.
Copyright ©2005 Medical Device & Diagnostic Industry
