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Tag Archives: Medical Device

11 Oct

Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use; Guidance for Industry and Food and Drug Administration Staff

Portable blood glucose meters that measure blood glucose values are used by millions of 28 people with diabetes every day as an aid in diabetes self-management. In recent years, concerns have been raised related to infection control issues involving blood glucose meters and lancing devices. This guidance document describes studies and criteria that FDA recommends

08 Jul

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Review under the Food and Drug Administration Modernization Act!! FDA Wants your Comments…

As per the paperwork reduction act of 1995 (the PRA), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an

16 Jun

Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions!!

Draft Guidance for your comments This draft guidance document provides clarity for FDA staff and industry regarding the benefit and risk factors FDA may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality and patient safety. FDA believes that explaining the factors listed in this draft guidance document will improve

10 Mar

Make your Old Medical Device “New” Again

FDA requests your comments!! With concern about the quality, safety and continued effectiveness of medical devices which have been subjected to continued servicing, maintenance, refurbishment and possible alteration by Original Equipment manufacturers(OEMs) or 3rd party entities, FDA is finally reviewing its policy and is re-approaching the issue. FDA has asked for comments about the Regulations

26 Jan

Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices

FDA wants your comments!! Your chance to be heard!!!!! FDA announced an opportunity for public comment on the guidance document for Design Considerations and premarket Submission Recommendations for Interoperable Medical Devices. In today’s world where technology plays an important role, the Medical Device industry is bringing in new technologies in market. The Healthcare industry is

11 Apr

NDC/NHRIC Labeler codes for Medical Devices – FDA’s stand

We have been recently getting a lot of queries whether or not FDA can still issue NDC/NHRIC labeler codes for medical devices with the recent advent of the new UDI (Unique Device Identification) regulations being implemented by the FDA. The answer to this question is NO!!! Some of the clients are arguing about the NDC

17 Mar

Final Release – Reprocessing Medical devices in Health Care Settings

Clients, please be aware of the final release of the guidance document for reprocessing of medical devices. Earlier this month news came out of a fatal bacterial infection at UCLA Medical Center. The infection was spread by an endoscope, a type of reusable medical device. This sparked discussion around the topic of what role the

03 Feb

Draft guidance announcement! Medical Device Accessories

Accessories to medical devices, what are they and how does FDA regulate them? FDA released a draft guidance document to address just this question. As with all draft guidance’s, it is currently open for comment, details on how to submit comments are provided at the end of this update. FDA defines an accessory to be

08 Aug

What You Need to Know About Contract Manufacturing

An FDA Veteran Describes What You Need to Know Before Working With a New Outsourcing Partner Alan Schwartz, Contributing Writer The medical device industry is a very dynamic one, with new companies being set up constantly—bringing either new, unique devices or better designed me-too products to market on a regular basis. Most of these companies

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