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Written By Elise Miner - Validation Manager, QPharma
Earlier this month, the FDA proposed a regulation that will reclassify certain hardware and software products used with medical devices. The new regulation defines these products, known as Medical Device Data Systems (MDDS), as systems that are intended to provide one or more of the following uses:
Previously, MDDS were categorized as Class III, high-risk and requiring pre-market approval. This was the case because all medical devices unknown prior to 1976 were automatically placed in Class III by default. However, according to the new rule, MDDS will now be Class I, low-risk and subject to general controls and quality standards. The rationale behind this reclassification stems from the amazing growth and development of the use of medical devices and MDDS over the past decade. Such expansion has led to new risk factors that did not previously exist.
But the changes the FDA are making to the MDDS rule affect both sides of the spectrum. It simultaneously enlarged the MDDS category to include more software that might have been thought to be unregulated, but also now captures products that might otherwise have been placed in higher risk categories.
Manufacturers finding themselves with products that fit the MDDS description must now adhere to all Class I requirements including registering with the FDA, listing their MDDS products, reporting adverse events and complying with FDA’s Quality Systems regulation. By the same token, manufacturers that had previously categorized their MDDS as high –risk now stand a less taxing path to market.
The rule is set to become effective on April 14, 2011. By May 14, 2011, companies that make MDDS must have registered with FDA and listed the MDDS product. By April 2012, companies making MDDS must have fully functioning quality systems and be in compliance with the medical device reporting rules.
Is this measure a preview of more to come? It proves to clarify the boundaries around this one particular class of products, but begs the question - When the FDA will take steps to further define and reclassify more software and hardware. At the very least, it’s a step in the right direction.
FDA Proposed Rule: http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-2325.pdf
Earlier this month, the FDA proposed a regulation that will reclassify certain hardware and software products used with medical devices. The new regulation defines these products, known as Medical Device Data Systems (MDDS), as systems that are intended to provide one or more of the following uses:
- The electronic transfer or exchange of medical device data from a medical device, without altering the function or parameters of any connected devices
- The electronic storage and retrieval of medical device data, without altering the function or parameters of connected devices
- The electronic display of medical device data, without altering the function or parameters of connected devices
- The electronic conversion of medical device data from one format to another format in accordance with a preset specification
Manufacturers finding themselves with products that fit the MDDS description must now adhere to all Class I requirements including registering with the FDA, listing their MDDS products, reporting adverse events and complying with FDA’s Quality Systems regulation. By the same token, manufacturers that had previously categorized their MDDS as high –risk now stand a less taxing path to market.
The rule is set to become effective on April 14, 2011. By May 14, 2011, companies that make MDDS must have registered with FDA and listed the MDDS product. By April 2012, companies making MDDS must have fully functioning quality systems and be in compliance with the medical device reporting rules.
Is this measure a preview of more to come? It proves to clarify the boundaries around this one particular class of products, but begs the question - When the FDA will take steps to further define and reclassify more software and hardware. At the very least, it’s a step in the right direction.
FDA Proposed Rule: http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-2325.pdf
Oh' I never knew about this New FDA regulation for Medical Device Data System. Thanks for sharing this informative post. I am well updated.
ReplyDelete-mel-
There are a couple of big "gotchas" here. First, these companies will need design controls and have developed their software under those controls; while 21 CFR 820.30 generally exempts Class I devices from design controls, the gotcha is that software is ALWAYS subject to those controls. Few of these companies are going to understand FDA's requirements for design controls.
ReplyDeleteSecondly, many of these firms outsource the development of these programs to another firm, even overseas firms. Those firms may ALSO be required to register with FDA and maintain design controls as a "specification developer." You can bet that these software design and coding firms have no idea about FDA registration or requirements.
This has been coming for years, ever since FDA's controversial Patterson warning letter (in which FDA declared their office automation product Eaglesoft to be an "unclassified" medical device even though the legal definition of that term deals with devices already on the market before 1976), and last year CDRH's John Murray alluded to this new regulation when he said that FDA would start treating many healthcare-related software applications as "medical devices."
Less clear is the status of software that does MDDS-type things, but for a manufacturer rather than a practitioner or patient. For example, how about a device manufacturer whose software imports scans from a hospital's MRI machine and uses them to make a custom implant; or the drug company that custom-compounds a drug based on the patient's blood chemistry results transmitted from a clinic? These are clearly MDDSs, but are not themselves "marketed" and so are not subject to the new listing requirements. Does FDA have another new regulation waiting in the wings?