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Welcome to GPC USA - Regulation

In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program. The federal agency responsible for regulating medical devices is the Food and Drug Administration (FDA)—an agency within the Department of Health and Human Services (HHS). FDA’s Center for Devices and Radiological Health (CDRH) is primarily responsible for medical device premarket review. Another center, the Center for Biologics Evaluation and Research (CBER), regulates devices associated with blood collection and processing procedures, cellular products and tissues.  

FDA's legal authority to regulate both medical devices and electronic radiation-emitting products is the Federal Food Drug & Cosmetic Act (FD&C Act). The FD&C Act contains provisions, that is, regulatory requirements, that define FDA's level of control over these products. To fulfil the provisions of the FD&C Act that apply to medical devices and radiation-emitting products, FDA develops, publishes and implements regulations.

  • Federal Register (FR) 

  • The FR is the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents. 

  • Proposed rules are initially published in the Federal Register for public comment and subsequently published in the Code of Federal Regulations after the rule is final. 

  • Final regulations published in the FR are subsequently placed or codified into the printed edition of the Code of Federal Regulations (CFR) on an annual basis. 

  • The recently published FR's on the Regulations.gov web page. 

  • Code of Federal Regulations (CFR) 

  • The CFR is a codification of the general and permanent rules that were published in the FR by the Executive departments and agencies of the Federal Government.  

  • It is divided into 50 titles that represent broad areas subject to Federal regulation. 

  • The FDA regulates food, drugs, medical devices, biologics, cosmetics and radiation emitting products in the USA. 

  • FDA’s Centre for Devices and Radiological Health (CDRH) is responsible for regulating manufacturers of medical devices. Medical devices are regulated under the Federal Food Drug & Cosmetic Act (FD&C Act) Part 800-1299. 

  • Manufacturers importing medical devices into the USA must designate a United States agent, register the establishment, list the device, manufacture according to the quality system requirements and file a Premarket Notification 510 (k) or a Premarket Approval. 

  • A post marketing surveillance system is required (21 CFR Part 803). Medical devices are divided into Class I, Class II and Class III where class I devices represent the lowest risk and class III devices represent the highest risk. Most Class I devices and some Class II devices are exempted from a Premarket Notification 510 (k).

  • The FDA does not “certify" devices, and the FDA logo is for the official use of the FDA and not for use on private sector materials. The FDA does not issue registration certificates to medical device facilities nor does the FDA certify information for facilities that have registered their establishments and listed their medical devices. 

  • All device establishments required to register must complete their annual registration for each Fiscal Year between October 1 and December 31. 

  • FDA is aware that various firms may be offering their services to assist domestic and/or foreign facilities to register with FDA. Please note that these firms are not affiliated with FDA, nor has the agency contracted with any firms to register facilities. FDA does not use any outside contractors to notify or bill regulated industry about the need to register. FDA does not require firms to hire someone to complete the on-line registration process. 

  • In completing product listings for facilities, bear in mind that you are required to identify any that are combination products.

Serial No. 

Application Type 

Standard Fee 

Small Business Fee 

01. 

510(k) 

$11,594 

$2,899 

02. 

PMA, PDP, PMR, BLA 

$340,995 

$85,249 

03. 

De Novo Classification Request 

$102,299 

$25,575 

04. 

Panel-track Supplement 

$255,747 

$63,937 

05. 

180-Day Supplement 

$51,149 

$12,787 

06. 

Real-Time Supplement 

$23,870 

$5,968 

07. 

BLA Efficacy Supplement 

$340,995 

$85,249 

08. 

30-Day Notice 

$5,456 

$2,728 

09. 

Annual Fee for Periodic 
Reporting on a Class III device 
(PMAs, PDPs, and PMRs) 

$11,935 

$2,984 

How can GPC help you? 

  • Identification of compliance requirements under various guidelines including all data requirements.​ 

  • Data gap analysis and pre-assessment support​ 

  • Technical documentation support​ 

  • Pre and post submission support and technical liaison with authorities. 

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