MAY 2023 LIFE SCIENCE NEWS
The Intersection Of ISO 13485 And ISO 14971 Under The Proposed FDA QMSR
“The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes,2 which is in its third edition since its 1996 release. The FDA QSR has not been updated since its 1996 release and needs to be brought to the current state of the art. Incidentally, the first edition of ISO 13485 was released at about the same time as the initial QSR, so 13485 has been updated twice while the FDA’s regulation has not been updated.”
FDA Proposes New, Easy-to-Read Medication Guide for Patients, Patient Medication Information
Providing people with accurate and timely information to help them take their prescription medications safely and effectively is an important priority for the U.S. Food and Drug Administration. Evidence suggests that more easy-to-read information can help patients reduce preventable adverse drug reactions and improve health outcomes. Currently, patients may receive one or more types of written information for prescription drugs and certain biological products, depending on the medication they are prescribed. Studies have found that the current system for written information for prescription drugs and certain biological products can be confusing, conflicting, incomplete, or repetitive.
Who can donate blood? What to know about FDA’s new guidelines
The Food and Drug Administration updated its guidelines this week regarding who can donate blood in the United States, eliminating a decades-old rules stemming from the AIDS crisis that prohibited men who have sex with men from donating. The finalized guidelines pose the same questions to every donor — regardless of gender or sexual orientation — including whether potential donors have had anal sex with new partners in the last three months, which carries a higher risk of HIV transmission than other forms of sex. The FDA first proposed the changes in January.
AI in drug manufacturing: Stakeholders call for harmonization, further guidance
A discussion paper released by the US Food and Drug Administration (FDA) on incorporating artificial intelligence (AI) and advanced manufacturing techniques into the pharmaceutical manufacturing regulatory framework has yielded numerous and wide-ranging comments from stakeholders detailing their current and intended uses for the technology. FDA asked for more information on the types of AI applications used, the elements of AI-based models in a current good manufacturing practice (CGMP) environment, practices for validating and maintaining self-learning AI models, appropriate AI data management and what guidance for AI stakeholders would like to see, as well as other aspects of AI in pharmaceutical manufacturing not listed in the discussion paper.
APRIL 2023 LIFE SCIENCE NEWS
Four Sustainability Updates in (and Around) Healthcare Packaging
“The Ohio State University Wexner Medical Center is striving to become a zero-waste campus by 2025 (i.e., 90% diversion of non-hazardous waste away from landfills) through an economically sustainable waste diversion program. To make progress towards this ambitious goal within a three-year deadline, the medical center must rapidly ramp up its waste diversion and waste prevention practices.”
FDA ramps up for transition to QMSR
“The US Food and Drug Administration (FDA) is working to finalize its proposal to align its device Quality System Regulation (QSR) with the international standard ISO 13485:2016, creating the Quality Management System Regulation (QMSR). In preparation for the final rule, the agency is readying for the change internally by updating its technology systems, training staff and replacing the Quality System Inspection Technique (QSIT). “If you’ve ever seen a 483 form, list of observations about inspections, you know that we have databases from which we pull citations and observations that are connected to the regulation, the current [21 CFR Part] 820. So, all of that has to change,”
Warning Letter Serves as Reminder to Device Industry
“Medical device manufacturers with products on the U.S. market need to remember to seek FDA’s blessing when a previously cleared device is significantly modified. It’s a lesson that London, England-based Medivance Instruments is learning the hard way. The company holds a 510(k) clearance for its Velopex Aquacut Fluid Abrasion Unit, a device intended for use in a range of dental procedures. However, according to a recent FDA warning letter to Medivance Instruments, the Velopex device has been significantly modified in multiple ways since it was cleared in 2003.”
FDA outlines risk-based approach to monitoring clinical trials
The US Food and Drug Administration (FDA) on Tuesday issued final guidance meant to assist drug and medical device makers in developing risk-based monitoring strategies for clinical investigations involving drugs, biologics and medical devices. The question-and-answer format document states that “clinical investigation monitoring is a quality control tool for determining whether investigation activities are being carried out as planned. This guidance contains recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results.”
MARCH 2023 LIFE SCIENCE NEWS
Under a new law, FDA submissions must prove that medical devices meet cybersecurity standards
“Already this year, major medtech makers including BD, Insulet and Zoll Medical have all alerted their customers to cybersecurity vulnerabilities in their medical devices that could potentially compromise sensitive health information or other personal data. Hoping to prevent any such breaches is the FDA, which will now require medical device makers to submit information about their cybersecurity efforts alongside applications for regulatory clearance of their devices. The new requirements went live Wednesday, as a $1.7 trillion federal omnibus spending bill took effect, though the FDA said in an accompanying guidance that it doesn’t intend to begin enforcing them until Oct. 1, at which point device makers will “have had sufficient time” to adjust to the guidelines.”
QMSR: Start now to be ready for final rule, slated for December
“The US Food and Drug Administration (FDA) asserts that it is on track to release a final rule this December that harmonizes the agency’s decades-old Quality System Regulation (QSR) with international standard ISO 13485:2016. Despite that deadline being roughly eight months away, it’s never too early for industry to prep for its arrival, two longtime experts say. The FDA released its draft Quality Management System Regulation (QMSR) in February 2022; the agency had been busy combining the QSR with ISO 13485 since early 2018 (RELATED: QMSR: FDA proposes QSR overhaul after years of delays, Regulatory Focus 22 February 2022). The QMSR, when finalized, should be shorter in length than the QSR because the current regulation’s requirements are already “substantively similar” to what’s found in the quality systems standard from the International Organization for Standardization (ISO).”
Significant regulation overhaul sees clinical trial approvals streamlined
“The Medicines and Healthcare products Regulation Agency (MHRA) is introducing a new series of measures to make it faster and easier to gain approval and to run clinical trials in the UK. The new framework, published last week, is said to be the “biggest overhaul in UK clinical trials regulation in over 20 years and will help to make the UK one of the best countries in the world to conduct clinical research for patients and researchers”. Under the new framework, clinical trial application processes in the UK will be more proportionate, streamlined and flexible without compromising on safety, helping to cement the UK as an attractive destination for trials, including global “multi-site” trials. Health and Social Care Secretary Steve Barclay said: “These changes will help speed up clinical trials, without compromising on safety, and encourage the development of new and better medicines for patients. They come after the government announced additional funding of £10 million for the MHRA to accelerate the delivery of cutting-edge treatment including cancer vaccines.”
United States: Status of FDA COVID-19-related guidance documents in the ‘post-COVID’ era
“On March 13, 2023, FDA issued a notice regarding guidance documents related to the COVID-19 pandemic, including which of the guidance documents will no longer be in effect after expiration of the declaration of the COVID-19 public health emergency (PHE). The notice followed a Department of Health and Human Services announcement on February 9 that it is planning for the declaration of the PHE to expire on May 11, 2023
In particular, FDA is announcing that COVID-19-related guidance documents will fall under one of the following three categories:
- No longer be in effect when the PHE declaration expires
- a) Revised to continue in effect for 180 days after the PHE declaration expires, then will no longer be in effect
b) Revised to continue in effect for 180 days after the PHE declaration expires, during which time FDA plans to further revise these guidance documents
- Will remain in effect when the COVID-19 PHE declaration expires.“
FEBRUARY 2023 LIFE SCIENCE NEWS
Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU
“The EU is introducing more time to certify certain medical devices under EU Medical Device Regulation (“EU MDR”). The proposal recognises the challenges in capacity across notified bodies. These changes made to the EU MDR will apply automatically in Northern Ireland under the terms of the Northern Ireland Protocol. The MHRA is working to consider carefully what the implications of these revisions are for acceptance of CE marked medical devices on the Great Britain (GB) market. At present, a device with a valid CE mark can be placed on the GB market until 30 June 2023. That would include certificates valid under the latest EU’s revised transitional arrangements, if they are adopted as proposed.”
Stakeholders want clarity from FDA on circumstances for delaying or limiting inspections
“The Advanced Medical Technology Association (AdvaMed) and ophthalmology product maker Alcon urged the US Food and Drug Administration (FDA) to allow manufacturers more latitude in being able to delay or limit inspections before deeming products adulterated. They also urged FDA to clarify what constitutes a reasonable explanation for delaying, denying or refusing an inspection. These comments were in response to FDA’s revised draft guidance issued in December 2022 on circumstances for delaying, denying or limiting an inspection. Under current FDA guidance, only drugs can be adulterated if FDA inspectors are barred the door. The draft guidance aligns with an update in the law under the FDA Reauthorization Act (FDARA), which requires devices to be deemed adulterated and refused entry for firms that block FDA inspections.”
AI devices need dedicated FDA regulatory pathway to reduce bias risk, say researchers
“Because AI is trained on existing data, it can reflect and potentially amplify the problems in those data sets, including a lack of information about the ways that many diseases affect groups that are traditionally underserved by advanced medicine. Other researchers have already encountered such issues in algorithms that under-diagnose lung disease in minority populations and give more resources to white patients. The U.S. lacks dedicated healthcare AI regulations that address those risks. Researchers at the University of Pennsylvania and Oregon Health & Science University want that to change and have set out several paths forward in their paper. The team’s preferred option is for the FDA to create a new regulatory process and a panel that will “review all AI-driven SaMD functions to ensure that they demonstrate a low chance of exacerbating existing health disparities.” Proposed requirements include the evaluation of training and testing datasets, reporting on existing disparities, and metrics to evaluate device accuracy across groups.”
Data Issues Abound as DSCSA Deadline Nears
“The healthcare supply chain is at a critical inflection point, with fewer than 300 days left to comply with the 2013 Drug Supply Chain Security Act (DSCSA). By November 27, 2023, trading partners will be required to add serialized pharmaceutical product data to the transaction information already provided when a DSCSA-covered product changes ownership. Once fully implemented, data movement within the pharmaceutical supply chain will be completely transformed, providing additional assurance to Americans that the medicines they pick up at the pharmacy counter are safe and legitimate. However, connecting to trading partners via GS1 Electronic Product Code Information Services (EPCIS) to share serialized item-level data can be a complex and challenging process between product manufacturers and distributors.“
INDUSTRY NEWS 2022- OUR TOP STORIES!!
QMSR: FDA proposes QSR overhaul after years of delays
“Four years after the US Food and Drug Administration (FDA) signaled its intent to align its Quality System Regulation (QSR) with the international standard ISO 13485:2016, the agency on Tuesday issued a proposed rule laying out its vision for the long-awaited regulatory overhaul. The resulting regulation would be dubbed the Quality Management System Regulation (QMSR). According to FDA’s analysis, the regulation as written would result in a cost savings of $439-533 million over 10 years for medical device establishments that comply with both standards. FDA is also proposing to give device makers one year from the publication of the final rule to adapt to the new regulatory requirements.”
Medtech firms warn Government of urgent need for action on EU certification process
“A group representing Ireland’s medical device industry warned the Government that the implementation of new EU rules is running at under capacity. The EU’s Medical Device Regulation (MDR) came into application in May of last year and introduced stricter safety rules for medical devices. It requires device manufacturers to ensure new and existing products are certified under the updated rules. In a letter to Health Minister Stephen Donnelly, the Irish Medtech Association, part of Ibec, said “urgent action” is needed on a European level to prevent shortages of medical devices.”
FDA official: Most drug GMP warning letters in FY2022 stemmed from onsite inspections
“A US Food and Drug Administration (FDA) official said that most warning letters issued for drug good manufacturing practice (GMP) issues in fiscal year 2022 were the result of onsite inspections, reversing a pandemic-era trend of enforcement actions triggered by the use of alternative tools. Yet the agency faces “incredible challenges” going forward, as it tackles a backlog of inspections that were put on hold during the pandemic, asserted Jeffrey Meng, program division director, Division of Pharmaceutical Quality Operations III, Office of Regulatory Affairs…”
UK medical devices law reforms delayed till 2024
“The regulator said it was “introducing a 12-month extension to the implementation of the future Medical Device Regulations, with an aim to bring the new regulations into force by July 2024” to ensure the new system of regulation is ready in time and to minimise the risk of supply disruptions for UK patients. The delay means manufacturers whose medical devices have a ‘CE’ marking, which certifies their compliance with EU medical device regulations, will be able to continue placing their devices on the Great Britain market up until 30 June 2024, not 30 June 2023 as previously indicated by the UK government.”
EU issues long-awaited GMP Annex 1 revision
“The EU’s eagerly anticipated revision of its good manufacturing practice (GMP) Annex 1 for sterile drug products was released on Thursday after 14 years of development. The revised requirements, which are set to take effect 25 August 2023, govern the manufacturing of sterile drugs made in the EU, as well as imported products. The revised Annex comes after hints earlier this year that it be out in mid-2022. The existing Annex I has been in effect since 2008 and has undergone several proposed revisions since then.”
FDA Lists Mechanisms to Comply With CGMP Requirements for Combination Products
“As required by the 21st Century Cures Act (Cures Act), the Food and Drug Administration is finalizing a list of alternative or streamlined mechanisms for complying with the current good manufacturing practice (CGMP) requirements for combination products. While the FDA has provided examples in this notice of the types of mechanisms that may be appropriate, CP manufacturers should consider the suitability of an approach in the context of their product and manufacturing process. and CP manufacturer.”
FDA Wants More Diversity in Clinical Trials
“The U.S. Food and Drug Administration says companies that produce drugs and other medical products should submit plans for how they will increase the number of Blacks and other underrepresented groups in clinical trials, the agency said Wednesday. Though racial and ethnic minorities are affected disproportionately by certain diseases, they are frequently underrepresented in medical research, the FDA said in a news release. Barriers to participation include suspicion of doctors, religion, health illiteracy, and lack of understanding of clinical trials.”
FDA details plans to expand remote safety assessments for device makers
“The FDA wants to keep and expand its ability to remotely conduct safety assessments even after the COVID-19 pandemic. The federal agency recently detailed its plans in new draft guidance for remote regulatory assessments (RRAs) covering all FDA-regulated products. FDA staff started conducting remote assessments when unable to travel due to COVID-19 restrictions, and regulators said RRAs will continue to be valuable beyond the pandemic.”
