Quality Management System Regulation (QMSR): FDA Final Rule

OMEDtechNews & Events

The US Food and Drug Administration (FDA) issued the Quality Management System Regulation (QMSR) final rule on January 31, 2024.  This final rule of the QMSR will coordinate central components of a device manufacturer’s Quality Management System (QMS) making it more in line with other regulatory authorities worldwide.  This extensive regulation modifies the current good manufacturing practice (CGMP) requirements stated in the Quality System regulation found in 21 CFR 820 and “FDA is accomplishing this primarily by incorporating by reference the 2016 edition of ISO 13485.” (1) ISO 13485 is a standard for medical devices and quality management systems. This new rule will take effect in 2 years on February 2, 2026.

FDA Final Rule Update Quality Management System Regulation

This new regulation will encourage uniformity in the regulation of devices. Over time, this will provide patients with more effective access to medical devices. The alignment with other regulatory authorities will expedite the introduction of high-quality, safe, and efficient devices available for patients.  Eventually, the Quality Management System Regulation will also lower industry training costs because internal training will now be able to cover a more uniform set of requirements.

The FDA encourages all parties in the medical device sector to become acquainted with the specifics of the QMSR Final Rule. Manufacturers can then take the required steps to be in compliance by the effectiveness date of February 2, 2026.  During the transition to the QMSR, manufacturers must abide by the QS regulation until the rule takes effect.  Manufacturers will need to address changes to their current quality management system procedures, quality agreements, or other documentation referencing the QSR.  During this phase, OMEDtech can help with questions and with the transition to the new QMSR. 

(1) Final Rule, Medical Devices; Quality System Regulation Amendments, 89 Fed. Reg. 7496 (Feb. 2, 2024)

When Do I Call It Rework?

OMEDtechRework

By Melissa Glass

When do I call it a rework? Several variables distinguish a rework from a repair or nonconformance. This can mean many things as applied to business, lean Six Sigma operations, pharmaceutical or medical device manufacturing.

Is it a nonconformance?

Nonconformance occurs when a device does not meet a specific requirement. In medical device manufacturing, nonconformance is an umbrella that captures deviations from quality standards, regulatory requirements, procedural errors, equipment failures, or material defects. Nonconformance programs must address the root cause of systemic issues or failures and take corrective actions to prevent a reoccurrence of nonconformity.

Is it a repair?

Repairs address out-of-specification products after releasing a device for distribution to the customer. A repair takes place at the point of use, or withdrawn for repair service and returned to the customer. The repair process addresses non-conforming parts and replaces them with conforming parts of the same PN. Medical device recalls may involve repairs with new part numbers to meet new requirements or specifications.

“Rework means action taken on a nonconforming product so that it will fulfill the specified DMR [Device Manufacturing Record] requirements before it is released for distribution.”

21 CFR 820.3 (x)

Is it rework?

Rework takes specific corrective action to address any nonconformance found within manufacturing. Devices out of specifications at any point of the manufacturing process can undergo rework to salvage nonconforming products.

“Rework means action taken on a nonconforming product so that it will fulfill the specified DMR [Device Manufacturing Record] requirements before it is released for distribution.” 21 CFR 820.3 (x)

Additional costs may arise to take corrective action, to ensure the product meets specifications after the rework, and to document actions and rationale in the DHR. Trending activities can aid in understanding where a rework occurs in the manufacturing process and can prevent future issues by addressing the root cause of the nonconformance. A rework can also help an organization’s bottom line. This process allows expensive and conforming materials to be salvaged and used for the final product.

For example, consider a device with ten parts in its Bill of Materials (BOM). The device is out of specification 60% of the way through manufacturing (6 of 10 parts built or assembled) and only one part is nonconforming. Rework of the product will replace or repair the nonconforming part. This process reduces material scrap, salvages the five remaining parts, and allows a complete product within specification to go out to the customer.

Key Components of Rework

The key components of rework required by ISO 13485 and 21 CFR 820.90 include:

  1. Consideration and appropriate action for potential adverse effects of rework on the product.
  2. Rework products must be verified to ensure all applicable acceptance criteria and regulatory requirements are met. Retesting and re-evaluation of the product after the completion of rework is required to ensure current approved specifications are met, reviewed, and approved.
  3. Records or rework shall be maintained within the Device History Record (DHR). Records should include the nonconformity, actions taken for rework and reevaluation, determination of potential adverse effects from rework, any investigation into the nonconformity, and rationale for the decision to rework and release the product.

In many businesses “rework” can carry a negative connotation. However, implementing this process in medical device manufacturing benefits businesses. It ensures the end product is within specifications and with minimal waste.

GUDID Update – Premarket Submission Supplement Number

OMEDtechNews & Events

GUDID Enhancements

The GUDID system will soon undergo enhancements.  These improvements will allow the system to continue meeting user and program needs. The GUDID Release 2.3 will include the public release of the Premarket Submission Number and the Supplement Number which will become part of each GUDID DI record.

Before the GUDID enhancements are implemented, the FDA suggests that users review their GUDID listings and prepare for how they may be impacted by the changes. In May 2018, the FDA plans to update GUDID so that labelers will have the opportunity to review the premarket submission number and to identify the releasability of a premarket submission number and supplement number for their GUDID listings. Premarket numbers may be kept confidential depending on their confidentiality designation.

How to Prepare

Users can review and make changes to any confidentiality designations on the Device Registration and Listing Module (DRLM). It is important to prepare for the changes by checking your GUDID records and confirming they have all relevant listing numbers and to review and/or change the confidentiality designations. The public release of premarket submission and supplement numbers will occur in June 2018.

Resources:

FDA Gives UDI Extension for Low-Risk Medical Devices

OMEDtechNews & Events

FDA Issues Letter to UDI Device Labelers

The FDA has provided a notice to device labelers with an update on the Unique Device Identification (UDI) compliance dates. Originally, the UDI was to be marked on labels at different time frames with regard to the classification level of the device. The FDA has extended UDI compliance dates for certain types of lower risk Class I and unclassified devices. This extension will allow the FDA to further develop the UDI system and gain the full potential of UDI data. The UDI label requirement for certain Class I and unclassified devices has been extended to September 24, 2020. The UDI direct mark for these lower risk devices will need to be in place by September 24, 2022. A new guidance document will be issued to provide information on the enforcement discretion for labeling, GUDID submission, standard date formatting and direct mark requirements for low-risk medical devices.

FDA Regulatory Guidelines for ENDS

OMEDtechNews & Events

A rule has been passed that gives the FDA regulatory authority over most aspects of ENDS products.  The new rule allows the FDA to regulate all ENDS, including: vaporizers, vape pens, timehookah pens, E-Cigarettes, e-pipes, and all other ENDS.  These regulations cover everything from the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS. The new regulation encompasses components of ENDS such as: E-liquids, cartridges, atomizers, flavorings for ENDS, cartomizers, clearomizers, digital display, tank systems, drip tips, and programmable software.  If you operate a vape shop that mixes or prepares liquid nicotine or nicotine-containing e-liquids, or creates or modifies any type of ENDS, you are considered a manufacturer and must comply with all of the legal requirements for tobacco product manufacturers.

If you manufacture ENDS, these are some requirements that apply to you:
Resources:

Health Canada Transition to MDSAP

OMEDtechNews & Events

Health Canada has announced that they are in the process of changing from CMDCAS to MDSAP for medical device manufacturers to sell products in Canada.  The Medical Device Single Audit Program (MDSAP) pilot is regulatoryongoing and was created to have a single audit meet the quality management system requirements of multiple agencies based on ISO 13485:2003.  The switch to MDSAP will take place over a two year period, beginning at the conclusion the pilot on January 1, 2017.  Throughout the transition Health Canada will accept certificates from CMDCAS and MDSAP.  Medical device manufactures who wish to sell in Canada are encouraged to make the transition to MDSAP for their next CMDCAS audit.  By January 1, 2019 Health Canada will only accept MDSAP certificates.
For more information on the Health Canada transition from CMDCAS to MDSAP see the following:

Unique Device Identifier Convenience Kit Draft Guidance

OMEDtechDraft Guidance

The FDA has released a draft guidance: Unique Device Identifier Convenience Kit.  This document further explains the phrase “convenience kit” and how it applies to the UDI rule.  The FDA released their final rule for UDI on September 24, 2013, requiring most medical devices to label a UDI.  The UDI will have many benefits such as improved product information and faster product identification for problems or recalls.  convenience kitLabelers have been complying with the label and data submission requirements, ensuring that each device has its own UDI.  For convenience kits, each individual device does not have to have a UDI as long as the main container of the kit bears a UDI.  Previously, a convenience kit included implantable devices in sets or trays that would be repeatedly used and sterilized.  The FDA has determined that this previous use of convenience kit did not fulfill the UDI rule.  The FDA currently defines “convenience kit” at 21 CFR 801.3 142 as “applying solely to two or more different medical devices packaged together for the convenience of the user where they are intended to remain packaged together and the individual devices within the package not replaced, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user.”  Read the full FDA documents for all of the information on the UDI Final Rule or Convenience Kits.

Mobile Medical Device – Interactive Tool

OMEDtechNews & Events, Uncategorized

health appThere are more and more mobile health apps created every day.  Mobile medical devices and health apps must follow federal laws that apply to their product. The FTC has worked with the FDA, ONC, and OCR to release an interactive tool which will help mobile app developers understand which federal laws apply to their products. The user is able to go through a list of questions that will help to determine which laws apply to their mobile medical device or app. This interactive tool can point developers towards some of the federal regulations and laws they may need to follow.

The various groups and laws the interactive tool covers includes:

– OCR; HIPAA rules: protecting the privacy and security of applicable health information
– FDA; FD&C Act: regulates the safety and effectiveness of medical devices
– FTC; FTC Act: prohibits deceptive practices, privacy and data security, false claims about safety
– FTC; Health Breach Notification Rule: applicable businesses must provide notification of breaches of personal health record information

For more information on mobile medical devices:

Mobile Medical Applications Guidance
Mobile Medical Applications Website