CDRH’s Carl Fischer shares the agency’s approach to organizing and managing complaints.
“Inherently, complaints are just information—they’re pieces of information that come to FDA; they’re pieces of information that come to you as manufacturers,” according to Carl Fischer, Ph.D., director, Division of International Compliance Operations at CDRH. This may sound simple, but what does FDA do with them? Fischer offered a primer on complaints and how FDA categorizes them during the 2015 MedTech Intelligence Integrated Complaint Management conference in Washington, DC.
The definition section of CFR 820 defines complaints as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution”. In addition, CDRH’s Office of Compliance has an internal description of complaints.
Effective February 7, the agency will conduct inspections across all commodities, as well as mission-critical foreign and domestic inspections.
The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity, as well as considerations in designating eligible devices that may benefit populations impacted by disparities in health…
As of June 1, 2022, the Center for Devices and Radiological Health plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions.
The updated guidance document clarifies what constitutes a statement of the basis for the deficiency and includes examples of well-constructed deficiencies and industry responses to facilitate a more efficient review process.
The MedTech Intelligence staff consists of freelance journalists and industry contributing writers with decades of experience in covering medical device issues under the categories of business, market trends, product development, quality, regulatory, and operations.
You can contact our writing staff via our Contact Page.
Implementing a Regulatory Information Management (RIM) platform can significantly enhance regulatory processes. However, several misconceptions often prevent medical device companies from adopting these platforms. In this webinar, we'll debunk the most common myths and demonstrate how RIM platforms can quickly generate ROI.
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