In a regulated industry, the prevailing posture of regulatory representatives, in my experience, has been “Show me proof.” In fact, the philosophy I’ve heard repeated by regulators is “If it wasn’t documented, it didn’t happen.”
Labeling
EU MDR SSCP’s: The Importance of Readability
Among many of the new requirements that EU MDR has introduced, the Summary of Safety and Clinical Performance (SSCP) is certainly one of the more confusing ones for many firms. SSCP’s are required for implantable and Class III devices under EU MDR and is intended to be a public document summarizing important safety and clinical performance information about the device.
HIPAA and GDPR’s impact on Medical Devices
The European Union’s General Data Protection Regulation (GDPR), which was put into effect on May 25, 2018, is often considered to be one of world’s toughest laws when it comes to privacy and security. The regulations lay down privacy and security standards, imposing obligations on any/ all organizations having an impact on the people of EU, whether related to targeting or collecting data.
QSR and ISO 13485 Harmonization: Enforcement, the Ultimate Question
A couple of weeks ago I had the pleasure of moderating one of the Food and Drug Law Institute’s (FDLI) Law over Lunch Sessions. I spent my lunch hour with industry folks and lawyers discussing the forthcoming Quality System Regulation and ISO 13485 Harmonization. One topic emerged as the front-runner of what was on everyone’s mind: how is the FDA actually going to conduct enforcement for this? Can we expect to see a major change in FDA enforcement?
Incorporating GDP through Lean Six Sigma
GDP – far-reaching within all GxP-compliant organizations, and yet it can be a challenging point for many during audits. GDP, or Good Documentation Practices, are essential to maintaining an effective QMS. In a previous blog post, we touched on GDP, ALCOA+, and recommendations for successful GDP practices. In this post, we’re going to take a deeper dive into GDP, the governing regulations, and tips on consistently maintaining GDP.
How does FDA regulate Complementary and Alternative Medicine
Ayurveda, which is a traditional system of medicine, originated more than 3000 years ago. This field of medicine pays larger emphasis on building strength of mind and body to cope with different kinds of stressors and infections.[i] There are studies which suggest that ayurveda can reduce pain, manage with symptoms of type 2 diabetes, etc.
FDA Warning Letters Are Public Information
For a medical device organization, a Warning Letter from the FDA is the worst kind of publicity. It is an open disclosure of how poorly your organization complied with specific regulatory requirements.
Role Definition for Team Success
Earlier this month, the Ministry of Health and Family Welfare, Government of India released a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022 (“Bill”).[i] This Bill overhauls the pre-independence legislation enacted by the Central Legislative Assembly, the Drugs and Cosmetics Act, 1940,[ii] (“D&CA”) which is the primary legislation for regulation of drugs, biologics and medical devices at the moment.
Regulation of MedTech Products in India
Earlier this month, the Ministry of Health and Family Welfare, Government of India released a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022 (“Bill”).[i] This Bill overhauls the pre-independence legislation enacted by the Central Legislative Assembly, the Drugs and Cosmetics Act, 1940,[ii] (“D&CA”) which is the primary legislation for regulation of drugs, biologics and medical devices at the moment.
Internal Audit Readiness
Internal audits within the life science industry serve to evaluate a company’s internal controls to ensure compliance with laws and regulations for the safety and efficacy of products or services. Internal audits are performed by qualified individuals who do not have direct responsibility for the area that is being audited. Audits may be an anxiety-inducing word but can become much more inviting through efficient preparation, and results from an audit may even be used as powerful tools to continuously improve on one’s QMS.
Is There a U.S. National Award for Quality Excellence?
Yes! The U.S. Award for Quality Excellence is known as the Malcolm Baldridge National Quality Award (MBNQA). In fact, the award was established as Public Law 100-107 by an act of Congress under the Reagan administration in 1987.
FDA’s Refusal to Accept Process
Before the submission of a 510(k) premarket notification, the purpose of which is to notify the FDA of the manufacturer’s intent to market a medical device,[i] there is a provision for acceptance review. This review serves as a method to assess whether a submission is administratively complete and includes all necessary information for FDA to determine substantial equivalence under section 513(i) of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 United States Code (U.S.C.) § 360c(i)). To establish substantial equivalence under this provision, FDA must find the same intended use as the predicate device and either have the same technological characteristics as the predicate device or appropriate clinical and scientific data necessary to establish that the device is safe and effective as the predicate device. If the Authority is unable to determine substantial equivalence due to insufficient information, it may request for additional information to make that determination.
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