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FDA Issues Proposal To Amend The Medical Device Quality System Regulation

The FDA is proposing to modify the requirements of its Good Manufacturing Practices (cGMP) regulations to align them with the requirements of the ISO 13485:2016 standard for medical devices. The proposed amendments will affect the 21 CFR Part 4 regulation of combination products. They are part of the FDA’s efforts to align its regulations with the requirements of the international standard. The FDA aims to align its regulations with the requirements of other regulatory authorities in order to provide faster and more consistent access to safe and effective medical devices.

FDA’s Requirement for Manufacturers

The FDA’s requirement for manufacturers of medical devices to meet the requirements of 21 CFR Part 820 was first established in 1978. In 1997, the FDA added new design controls to the requirements for validating the safety and effectiveness of medical devices. The agency believed that this move would benefit the medical device industry and the public.

ISO 13485

The first version of ISO 13485, which was released in 1996, was focused on the requirements for the implementation of quality management systems for the medical device industry. The second edition, which was released in 2003, focused on the requirements for the regulation of these systems. The third edition, which was released in 2016, added new features and improved the quality management systems’ compliance with the requirements of 21 CFR Part 820.

The FDA is proposing to incorporate the requirements of the International Organization for Quality Management Systems (ISO 13485) in its regulations for medical devices. This would help ensure that the systems are used properly and meet the requirements of the FDA. The agency noted that the requirements of the two regulations are generally in line with each other. After the convergence of the two, the regulations for medical devices would be similar. The agency is also proposing to accept the requirements of the ISO 13485:2016 without modifying them. It will also propose a requirement that would replace the existing requirement.

The FDA is not proposing to modify the requirements of 21 CFR Part 820 for establishments that manufacture finished devices. However, the agency noted that the legal authority to require these requirements exists for certain entities. The agency noted that the proposed amendments would only address the extent of the conflicts between the conflicting regulations.

The finished device is any component or accessory that can function seamlessly on its own regardless of its packaging or labeling. A manufacturer is anyone who designs, manufactures, or processes a finished device. Nonconformity is a term that refers to the failure of a manufacturing process or component to meet a certain requirement.

Remanufacturers are those who modify or repackage a finished product to meet a specific requirement or improve its safety or performance. Rework is a process that involves taking a non-conforming product and performing a series of actions to ensure that it meets the requirements of the DMR. The validation process is a process that aims to establish that a manufacturing process consistently produces a finished product that meets its predetermined specifications.

Read more: https://www.complianceg.com/fda-proposal-to-medical-device-quality-system-regulations/

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What is the FDA’s approach to regulating AI/ML in SaMD (software as a medical device)?

As the quote goes, “Necessity is the mother of invention.” Ironically, we don’t know who invented that quote. It became an amalgam of people from Plato to a 19th-century theologian.

According to the FDA’s site, their first Medical Device approved was in 1976 through their CDHR division (Center for Devices and Radiological Health) per their 21CFR Parts 800-1299. As we know, medical devices fall into three categories, from low risk to high risk: Class I, II, and III

Per the Int’l Med Device Regulators Forum (IMDRF), the need for regulating SaMD, this new form of med device, came about as long ago as 2013, again through an amalgam of regulated elements within the med device world.

“SaMD” even reaches as far back as the 60s with Lockheed’s consideration of getting the first computerized information-handling system in the hospital sphere.

And do we know who the first company was to be approved by the FDA as a SaMD? I’m sure there was a hybrid that led up to that, and my guess is it’s archived somewhere, but my research didn’t come up with a specific name, but rather several SaMD firsts:

• Pacemakers • X-rays and MRIs • Bedside monitors • Urine analyzers • Glucometers • Spirometers

The FDA had a tall order to decipher regulatory compliance with this new hybrid. And companies in the SaMD space had to figure out how to manage regulatory affairs per the FDA.

Thanks to SaMD and other inventions, Artificial Intelligence (AI) and Machine Learning (ML) are pervasive in nearly everything we do now. Are Alexa, OK Google, and Siri listening and learning? Absolutely. Is their AI helping us with more targeted options for buying, listening, and purchasing… even routing us to avoid traffic? Definitely. Conversely, have you ever looked up airfare, car rentals, and hotels, only to find out after your third or fourth search that the prices went up for some reason…on the same day? Hmmm. What changed that? Supply and demand…AI/ML interpreted your multiple searches (and others) as increased demand, so they bump up the price a bit more or a lot more. This “encourages” you to buy quicker. Maybe using Incognito or an anonymous site helps? What are your thoughts?

Would SaMD do the same? Not unless the developing company wanted to violate HIPAA compliance and all kinds of regulatory violations.

For some guidance, per Deloitte, here are some Is and Is Not examples:

 What is and is not SaMD?

 SaMD

Software that can determine the  proper drug dose for a patient, given personalized patient data

Software that can detect and  diagnose a stroke by analyzing MRI images

Software that can track the size of  a mole over time and determine the risk of melanoma

Software that draws on data from  other digital devices to determine risk factors associated with epileptic  seizures

Not SaMD

Software that operates a pacemaker

Software that drives or controls an  infusion pump’s motors

Electronic health record systems

Software in the machines that  assemble medical devices

In one of my previous blogs, I mentioned that Apple, which started in 1976, hit it big with its desktops, but even bigger more significant with their iPhone innovation. That iPhone, coupled with the right software, became one of the forefront integrators of SaMD. Suddenly, eyes were opened to a world of information, whether on our wrist or transported electronically to the doctor. Abruptly, our eyes opened to a universe of data, accessible on our wrist and to be shipped electronically to our primary care physician.

Thanks to necessity, we can live healthier and longer and invent more!

[complianceg]

Investigating the contemplations being made by FDA for a proposed framework to regulate artificial intelligence (AI) and machine learning (ML) in software as a medical device (SaMD).

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