Changin' Up the Game: The FDA's Proposed Revisions to Medical Device Quality System Regulations, Explained
Amended FDA Regulations for Healthcare Equipment Quality Management Systems Unveiled
Listen up, folks! The U.S. Food and Drug Administration (FDA) has dropped a bombshell this year, announcing their intention to spruce up the existing good manufacturing practice (GMP) requirements for the Quality System Regulation (QSR). They're aiming to bring these U.S. quality systems in line with those used abroad. Here's a lowdown on what's cookin'.
Here's the Scoop:
- ISO 13485 Alignment: The FDA wants to hash things out with the 2016 edition of ISO 13485 (ISO 13485:2016) – a move that's all about consistency, repetition elimination, and streamlining device approvals. Key highlights include:
- Enhanced emphasis on risk management as a holistic product lifecycle consideration.
- Adherence to medical device quality systems in line with ISO 13485. However, they won't be pumping in the "Design and Development" provisions or labeling and packaging specifics from the standard.
- Up your Game, Risk Management: Be ready to pump up your risk management game as this overhaul puts the focus firmly on risk management throughout the product lifecycle, not just in emphatic validation stages.
- QMS Updates: The FDA will demand developers to wag their tails to a QMS that aligns with ISO 13485.
- Additional Recordkeeping Requirements: The FDA wishes to tighten up records by imposing signature and date requirements for records control, documenting medical device reporting info in complaints and service records, and demanding manufacturers to log UDI (Unique Device Identification). They'll also clarify a manufacturer's responsibility to dish out records when called for.
- QSIT Update: The FDA plans to revamp QSIT to match the new guidelines, though they're keeping mum about the particulars. They note that this won't replace ISO 13485 and training and education will be a crucial part of any changes.
Medical device companies can offer their two cents on these proposed updates until May 24, 2022. These changes have been brewing for a while, with the FDA maintaining that the current requirements in 21 CFR 820 and ISO 13485:2016 are near twins when toughened up. The FDA expects the new central rule to go live one year after final publication. So gather your pals at Sterling, because the crew of FDA medical device regulatory compliance experts can help you expand your quality system to get regulation’s nod. This ain't a long wait, so best be prepared for the updates ahead!
- In line with the FDA's proposed revisions to Medical Device Quality System Regulations, quality management for medtech companies must align with ISO 13485:2016, particularly focusing on risk management throughout the product lifecycle.
- Regulatory compliance in medical-conditions-related research, including health-and-wellness and science fields, is anticipated to grow stricter as the FDA adds additional recordkeeping requirements, emphasizing on UDI, signature and date requirements, and detailed documentation of medical device reporting information.
- Amid the FDA's intent to boost medical device quality systems, companies should gear up to bolster their risk management practices and adapt their Quality Management Systems (QMS) to meet international standards, paving the way for a smoother journey towards medical device regulatory compliance and eventual approval.
