CDRH Technical Amendment Updates Mailing Addresses

Regulatory NewsRegulatory News | 30 March 2018 |  By 

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) issued a technical amendment on Friday to update mailing addresses and fix typos, among other minor changes.

“One of the updates changes mailing addresses that previously went to the directors of the Office of Compliance and the Office of Communication, Education, and Radiation Programs at CDRH,” FDA said in its announcement. “Items previously directed to these office directors will instead be directed” to the CDRH director, including diagnostic x-ray systems, laser products and sunlamp products.

The announcement also states the amendment is part of a new approach being developed at CDRH for how its business is conducted and structured.

However, it is not to be confused with the CDRH reorganization plans to create a new to create a new “Total Product Life Cycle ‘Super’ Office” through which it intends to streamline regulatory review processes by combining several of its offices.

CDRH spokesperson Stephanie Caccomo told Focus the technical amendment was needed as the agency moved from its office in Rockville, MD, to Silver Spring, MD. The changes were made just for “updating office addresses fixing, some typos, and realigning some of the office tittles that have changed.”

The changes were also made as part of the agency’s preparation to issue the Code of Federal Regulations, Caccomo said. “This is a routine thing; you might see some other centers at FDA doing this soon as we get ready to begin producing the new print copy of the Code of Federal Regulations.”

Medical Device Technical Amendment


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