• Melita Ball

July 21, 2020 Blog Post

The information below is courtesy of the FDA website.


Center for Devices and Radiological Health (CDRH) Compliance Programs

FDA's Compliance Programs provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA. Compliance Programs are made available to the public under the Freedom of Information Act.


Compliance Programs do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used as long as the approach satisfies the requirements of the applicable statutes and regulations.


CDRH International Programs


CDRH’s commitment to assuring patients and providers have timely and continued access

to safe, effective, and high-quality medical devices involves engaging with international regulatory agencies to promote alignment in regulations.


Safety standards and regulations for medical devices vary from country to country. By engaging with regulatory authorities from other countries, CDRH works to implement policies and programs that align these standards and regulations.


CDRH meets with manufacturers and regulatory authorities such as Health Canada (HC), Japan’s Ministry of Health, Labour, and Welfare (MHLW), and the Asia-Pacific Economic Cooperation (APEC) to exchange regulatory information. CDRH exchanges information through web-based training, scientific and policy discussions, and confidentiality commitments.


CDRH’s international efforts are an important step in reducing barriers to medical devices with the potential for important public health impact reaching U.S. patients.


The International Medical Device Regulators Forum (IMDRF)External Link Disclaimer is a group of medical device regulators from around the world that have voluntarily come together to harmonize the regulatory requirements for medical products that vary from country to country. The current IMDRF members represent medical device regulatory authorities in:

As the U.S. member, the FDA actively participates in the IMDRF management committee as well as on IMDRF working groupsExternal Link Disclaimer including:

  • Unique Device Identification (UDI),

  • Personalized Medical Devices,

  • Standards,

  • Adverse Event Terminology,

  • Good Regulatory Review Practices,

  • Clinical Evaluation, and

  • Regulated Product Submission.

MDRF develops internationally agreed upon documents related to a wide variety of topics affecting medical devices. Draft IMDRF documents are available for public review and comment for a period of 60-90 days. IMDRF members, observers, and affiliate organizations will often solicit feedback from their stakeholders on these draft documents. In some cases—such as when the IMDRF document conveys guidance—the FDA may also solicit feedback on the draft IMDRF documents by publishing a notice of availability of the guidance for public comment in the Federal Register.

Thoughts? Please comment below …

Cheers!


Melita Ball


CEO and Principal ConsultantCopyright © 2019R  MBC & Affiliates, Inc|,  All rights reserved.



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