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Read important industry news with the latest articles on life sciences, manufacturing, and regulatory issues. 



Understanding the FDA Form 483: A Q&A with NSF’s Maxine Fritz

The FDA Form 483 is not an extensive list of all potential problems, but only those that inspectors can clearly identify as potential violations to FDA regulations. A detailed establishment inspection report (EIR) is written by the FDA inspector/inspection team that further outlines details of the company, its facilities, processes, quality systems, products, refusals, inspectional observations and discussion with management. The company should address these inspectional observations in a written response to the FDA following the inspection. The written response to the FDA 483 should outline the holistic improvements and corrective actions to be taken to remedy the observation and the timeline that it will take to complete them.


MDR/IVDR Guidance: MDCG Explains What’s Coming

“The European Commission’s Medical Device Coordination Group (MDCG) on Friday unveiled its plans for releasing almost 50 future guidance documents related to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), with the bulk of the new guidance coming on the oversight of notified bodies (NBs) and clinical investigations and evaluation (CIE).
The list also notes that much of the guidance will be endorsed by the MDCG later this year or in 2020, although for more than 20 guidance documents, the timing is to be decided.”



FDA is smashing the status quo for regulatory science

“Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality,” may have sounded like another bland and boring exercise in regulatory rhetoric. But it actually signals a revolutionary shift in regulatory velocity. Changes in the FDA’s Office of New Drugs (OND) will create enhanced review zones that cross disease areas and divisions to maximize access to more focused and innovative areas of regulatory expertise. These changes will, among other things, increase the number of OND offices overseeing product reviews from six to eight and increase the number of specific clinical review divisions from 19 to 27. The rationale is to make the FDA more efficient and help it better understand the diseases that are the aim of treatment by the drugs being evaluated for approval.


FDA Toughens Enforcement of Homeopathic Products

“FDA recently announced that it was taking two significant actions with respect to products marketed as homeopathic drugs, suggesting that increased enforcement related to these products is imminent. Homeopathy is a form of alternative medicine that is based on the idea that illnesses and their symptoms can be treated by small doses of ingredients that produce similar symptoms in healthy people.”



How Apple, Fitbit, Samsung and more are helping to modernize the FDA

“The healthcare industry is notorious for being slow to implement the type of technology that has revolutionized other industries such as retail, media and manufacturing. And there’s one big reason why: Regulation.  But that’s changing. Over the past decade, the US Food and Drug Administration has recognized that the systems the agency has in place to review and approve moderate- to high-risk hardware-based medical devices (such as implantable pacemakers and breast implants) aren’t appropriate for the low-risk software-based medical technologies flooding the market place today. (These include apps that help detect skin cancer and smartwatches that can take your blood pressure.) “

Read the Full Article HERE!

Safer Technologies Program for Medical Devices

“The FDA is introducing a new, voluntary program for certain medical devices and device-led combination products1 that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program; for example, this may include devices treating or diagnosing non-life-threatening or reasonably reversible conditions. Devices and device-led combination products are eligible for this program if they are subject to review under a premarket approval application (PMA), De Novo classificationrequest (“De Novo request”), or premarket notification (510(k)). “

Read the Full Article HERE

No-deal Brexit and the medical device industry: what to expect

“It’s safe to say very few commentators, within or outside the medical device industry, are actively championing the prospect of a no-deal Brexit. The EU is the UK’s biggest trading partner for health technologies, with around £2bn worth of goods exported into Europe each year and £3.3bn in European medical products imported into the country. Considering the sheer scale of the sector, talk of border delays, technical hold-ups and stockpiling bodybags hasn’t exactly painted a hopeful picture of the situation, and the overarching impact of no-deal on medical devices could be huge.”

Read the Full Article HERE


FDA explains plans for new pharmaceutical quality assessment system

“As part of its work to improve and modernize the quality assessment of drug applications, the FDA is developing a new, more standardized system, to be known as the Knowledge-aided Assessment & Structured Application (KASA), according to an article authored by officials from the FDA’s Center for Drug Evaluation and Research and published in the latest issue of the International Journal of Pharmaceutics. The authors describe KASA as a new system that captures and manages information in a structured format about the inherent risk and control approaches for product design, manufacturing and facilities.”

Read the Full Text HERE


Medical Device

Boosting Medical Device Quality and Profitability via a Common Product Model

“Medical device manufacturers face hurdles taller than ever in getting high-quality products to market faster, cost-effectively. Hindering their efforts are not just external factors but also internal processes for designing and producing those products. That is why it’s time for medical device companies to adopt a design-to-manufacturing environment where designers, engineering, and production teams are synchronized on a common product model. This approach improves both product quality and profitability by reducing errors in production while increasing yield rates.”


Industry backs Australia’s device identifier plan with caveats

When Australia’s Therapeutic Goods Administration ran the UDI consultation at the start of the year, it sought to gather views on the merits of introducing a system it thinks it will improve outcomes, including patient safety. The response to the consultation suggests the creation of a UDI system will go ahead. TGA found a “strong consensus across all stakeholder groups for the need to introduce the UDI system,” leading it to move forward with the development of legislation that will facilitate the work.


Compliance Training

Which GMPs for the cannabis industry? Pharmaceutical, food, or dietary supplement

“As with all molecular entities—whether chemical, botanical, or food-derived—FDA has one main focus: to ensure the safety, identity, purity and quality, and intended use of the ingredient is suitable for human and animal use. The use, dependent on the label claim and other regulatory considerations, can be categorized as a cosmetic, drug, food ingredient, or dietary supplement. Following a standard for manufacturing is the end result of implementing regulatory and quality considerations.​”


Changing  3 More Years: US calls for delay on the implementation of EUMDR/IVDR

The US highlighted what it believes to be the main issues surrounding the implementation of these regulations in a statement to the World Trade Organisation committee on technical barriers to trade: “Our industry is worried about their continued access to the EU’s USD 125 billion medical device market, 20 billion USD of which is supplied by US products. To date the European Commission (EC) has designated two Notified Bodies (NBs) – BSI UK and TUV SUD against MDR and none against IVDR. Additionally, only one regulation that has been put forward has been adopted so far; the EC issued the draft implementing regulation on the common specifications for the reprocessing of single-use medical devices in accordance with the MDR last month.


MDSAP – History and Advantages

“A few years ago, the U.S. Food and Drug Administration (FDA) realized there was no hope of achieving the legislated mandate of inspecting every Class II and Class III medical device manufacturer every two years. Congress would not provide the finances to hire enough investigators to perform those routine quality system inspections, in addition to required premarket approval (PMA) inspections, clinical trial (BIMO) inspections, and any recall or other enforcement inspections.



Changing Global Regulatory Landscape and Strategy for Drug and Device Operations

“Feature articles in July explored regulatory operations for drugs and devices. Topics included FDA and EU differences in cleanroom specifications, EU accelerated pathway programs, and data requirements for biosimilars versus the reference medicine. Other articles covered India’s new drug and clinical trial rules, China’s new guidance on regulatory inspection and analytical testing documentation, and medical device cybersecurity.”


EU MDR: Changing World of Classification

“The EU MDR is shaking up the medical device industry and classification rules have not been left untouched. In spite of this, a critical misunderstanding threatens Class I device manufacturers: As the end of the Medical Device Regulation’s (MDR) transition period, set for May 26, 2020, steadily beckons, there is a mistaken belief that that the need to comply with the EU MDR only applies to businesses manufacturing higher risk devices. In reality, Class I manufacturers are under just as much pressure as their peers who are making products in higher classes and should be acting swiftly to ensure that they confirm compliance with the new regulation or risk losing the ability to continue to sell their products in the EU.”


Australia on watch for possible EU notified body shortage

“Australia’s Therapeutic Goods Administration (TGA) on Friday said it is aware of industry concern about whether a sufficient number of notified bodies will be designated under the new European Union Medical Device Regulation in time for the May 2020 effective date. The Australian regulator said it is monitoring the situation and will consider the impact on manufacturers seeking certification for new products or looking to maintain existing certification.”


The U.S.-China trade war: Here’s what it means for medical device industry suppliers

“The U.S.-China trade war is certainly affecting where U.S. medical device companies decide to make their products. But don’t expect a bunch of manufacturing to come back to the United States. They are looking at what I would call ‘right-shoring,’” Freudenberg Medical CEO Max Kley said of his company’s medtech customers. For 12 years, Freudenberg (Carpinteria, Calif.) has had a plant in Shenzhen, China, just outside Hong Kong, where about 150 workers are engaged in thermoplastic and silicone injection molding and assembly of finished devices.”



FDAFDA Releases 20 Years of Data on Medical Device Adverse Event Reports

“The US Food and Drug Administration (FDA) recently ended its Alternative Summary Reporting (ASR) program for medical devices, revoked the related exemptions and on Friday made available on its website all adverse event reports received under ASR exemptions from 1999 to 2019.”


Time ManagementEuropean Health Ministers Fight to Postpone Medical Device Safety Laws

“German and Irish health ministers are leading calls for key elements of new European safety laws on medical devices to be effectively postponed, arguing that a lack of readiness among regulators risks creating shortages of vital implants and surgical equipment. Legislation on the licensing and monitoring of medical devices was passed in 2017 and is due to come into effect in May next year. But many health ministers now believe that Europe’s complex, part-privatized regulatory regime — which they were unwilling to scrap — has failed to prepare itself for the new set of rules.”


Combination Products and MDR: EMA Offers New Draft Guidance

“With a focus on drug-device combination products, the European Medicines Agency (EMA) on Monday issued its second draft guideline as part of a series related to the EU’s medical device regulation (MDR). The draft guideline covers the documentation expected for drug-device combinations (DDCs) in the quality part of the dossier for a marketing authorisation application (MAA). DDCs falling within the scope of this guideline are medical devices that are integral to the medicinal product, co-packaged with the medicinal product or referenced in the medicinal product information and obtained separately.”


US FDA-EMA Mutual Recognition: Two down, Two to go. 

 By Ben Hargreaves

Luxembourg and the Netherlands added to the US FDA-EMA mutual recognition agreement, which leaves just Germany and Slovakia to be verified.