inadequate warnings on medical device packaging

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The manufacturer of a medical device is the person who is responsible for the design production packaging and labelling of the device Manufacturers must have evidence demonstrating compliance with the relevant Essential Principles for their medical device including those that relate to labelling and instructions for use 2020/7/8Date: 7 August 2020Subject: Substandard/Falsified medical devices and personal protective equipment (PPE) used in the context of the COVID-19 pandemicWHO-identifier: 2020/3 version 1 Type of action: Advice to users of medical devices and PPE used for prevention treatment and care for COVID-19 Attention: Users of medical devices and PPE[1] procurement entities and customs

Medical device labelling obligations

The manufacturer of a medical device is the person who is responsible for the design production packaging and labelling of the device Manufacturers must have evidence demonstrating compliance with the relevant Essential Principles for their medical device including those that relate to labelling and instructions for use

2020/3/12Warnings are in the form of a label that describes the dangers Warning labels ensure consumers are aware of dangers a product may pose A consumer injured by a product that was not properly labeled may sue the product manufacturer or supplier for their injuries

6 Validating Medical Device Packaging must also be able to validate claims regarding the expected "shelf-life" of their products that is the period of time during which the seal strength (i e aseptic presentation) and integrity of the packaging (i e maintenance of

packaging materials and package leaflet (i e the sales presentation) 6 Section A - Labelling 1 The text of the labelling The Union authorisation of a medicinal product includes the labelling text which is the same throughout the Union Article 9 paragraph 4

2017/10/11European Medical Device Regulations (MDR) Jay Crowley USDM VP and UDI Practice Lead at USDM Life Sciences Warnings/ precautions Single use Device manufacturer name address Authorized representative address UDI carrier (DI PI) method

International Medical Device Regulators Forum

written printed or graphic information either appearing on the medical device itself or on the packaging of each unit or on the packaging of multiple devices Labelling: the label instructions for use and any other information that is related to

Any Medical Device for sale and use in People's Republic of China shall have Instructions for Use label and packaging logo in accordance with the requirements of the Regulation Two or three items of the Instructions for Uses labels and packaging logos can be

Truthful and Not Misleading • A drug is misbranded if its labeling is "false or misleading in any particular" (Section 502 (a)) • True statements can be misleading (e g if they lack clinical significance) • Material omissions can make otherwise "true"

2016/10/20Much has been written including by us about the Food and Drug Administration's enforcement approach (or lack thereof) concerning off-label promotion However FDA has not curled itself up into a ball abdicating its authority to proceed against unlawful promotion In the medical device realm manufacturers of devices that require 510(k) premarket notification submissions must take

'Child resistant' closures/fastenings and/or 'tactile warnings' (raised-profile warnings that can be understood by those with impaired vision) are also required in some cases The requirements to include such elements as part of packaging are triggered by either classification under a certain hazard class/category or by certain substances at specified concentrations

2020/1/7Under the FDA plain packaging law full-color cigarette warnings must be included on all cartons with images of side effects These graphics are required to take up 50 percent of the front and back of individual packs and a minimum of 20 percent of cigarette ads

Any Medical Device for sale and use in People's Republic of China shall have Instructions for Use label and packaging logo in accordance with the requirements of the Regulation Two or three items of the Instructions for Uses labels and packaging logos can be

inadequate See Schwartz Driver "Warnings in The Workplace: The Need for a Synthesis of Law and Communication Theory " 52 U Cin L Rev 38 54 (1983) These problems have made it dif-ficult for even the most well intentioned manufacturers to ensure

Guideline on Advertising etc of Medical Devices1

2 of safety purposes is broad implying that e g information on how to open a medical device package without damaging the medical device is also considered a safety purpose d) Informative material about health and dise ase provided there is no direct or indirect

Packaging and labeling are believed to be the cause of 33% of medication errors claims the 2006 Institute of Medicine (IOM) report Preventing Medication Errors To minimize the hazards that could lead to such errors FDA has published the first of three guidances for industry "Safety Considerations for Product Design to Minimize Medication Errors "

Testing demonstrates a package's ability to provide and maintain a sterile barrier around a medical device According to ANSI/AAMI/ISO 11607-1997 Packaging for Terminally Sterilized Medical Devices both seal-strength testing and package integrity testing are needed to properly validate a package's design and document its conformance to specifications

Medtech's countdown to the European Union's Medical Device Regulation was reset when the EU Commission Council and Parliament delayed the regulation's application to May 2021 The delay "takes the pressure off national authorities notified bodies manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis " according to the

Submission of inadequate mandatory problem reports by reporters for which Canada Vigilance - Medical Device Problem Reporting Program is consistently required to request additional information will result in the forwarding of this information to the Health

t) If the device emits radiation for medical purposes details of the nature type intensity and distribution of this radiation The instructions for use should also include where appropriate details allowing the medical staff to brief the patient on any contra indications warnings and any precautions to be taken

2020/7/8Date: 7 August 2020Subject: Substandard/Falsified medical devices and personal protective equipment (PPE) used in the context of the COVID-19 pandemicWHO-identifier: 2020/3 version 1 Type of action: Advice to users of medical devices and PPE used for prevention treatment and care for COVID-19 Attention: Users of medical devices and PPE[1] procurement entities and customs

More than 13 000 drugs and medical devices have been recalled in the past few years for reasons ranging from defective packaging to fatal side effects As a consumer it is important to be aware of devices or drugs that may affect your health In 2017 alone

t) If the device emits radiation for medical purposes details of the nature type intensity and distribution of this radiation The instructions for use should also include where appropriate details allowing the medical staff to brief the patient on any contra indications warnings and any precautions to be taken

13 1 Each device must be accompanied by the information needed to use it safely and properly taking account of the training and knowledge of the potential users 23 1(a) The medium format content legibility and location of the label and instructions for use