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The MDA established a risk-based framework for the classification of medical devices and a regulatory pathway for medical devices to get to the market, created a regulatory pathway for medical device clinical trials, and established several post-market requirements including manufacturer registration and device listing with the FDA, good ...
In 2003, Medtronic Physio-Control announced the launch of the LUCAS CPR device, a mechanical compression device driven pneumatically via an oxygen cylinder. It was able to provide more consistent and effective compression over longer spans than First Responders, and has now become an essential part of many ambulance kits. [4]
The following partial list contains marks which were originally legally protected trademarks, but which have subsequently lost legal protection as trademarks due to abandonment, non-renewal or improper issuance (the generic term predated the registration). Some marks retain trademark protection in certain countries despite being generic in others.
The official FDA format for NDCs separates the 3 segments with dashes. This is the format in which the NDC must be submitted by labelers since mandatory electronic listing was established in June 2009. [6] While the NDC is a 10-digit identifier, confusion exists because of a proliferation of different notations and variants.
The SPL Working Group has a Technical Team and a Process Communications Forum. Additionally, a variety of subteams address specific topical and subject issues. Current subteams include: Biologics, VetMeds, Devices, Generics, Establishment Registration Lifecycle, Labeling Content Lifecycle, and Over-the-Counter (OTC) Products.
A Central Equipment Identity Register (CEIR) is a database of mobile equipment identifiers (IMEI – for networks of GSM standard, MEID – for networks of CDMA standard). Such an identifier is assigned to each SIM slot of the mobile device.
Medical device cannot be classified as a class I device because the controls authorized are insufficient to provide reasonable assurance of the safety and effectiveness of the device. Medical device has sufficient information to establish a performance standard and it is necessary to establish a performance standard for the device.
register or a list of a specified type of regulated entities or activities — contains entries on companies officially authorized to perform a specified type of business, where prior obtaining of a permit, a license, a concession, or registration on such a list or register is a prerequisite required by law. Depending on situation, regulation ...