The Ombu Library, in the ISO 13485:2016 aisle, has an article on the Medical Device File from clause 4.2.3. The article explains the files requirements and includes the referenced MDSAP audit tasks and how the medical device File relates to the requirements in the MDD Annex II.

In a bill signed into law on January 22, 2018, the Medical Device Excise tax is suspended for two years, until January 1, 2020.

In an October 31, 2017 notice, Health Canada that says the MDSAP Consortium has implemented changes to reduce the audit time. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international/single-audit-program-reduction-audit-times.html

The changes include:

• Streamlined the MDSAP audit approach in the revised version of the audit model. This has reduced the total number of tasks to be accomplished and reduced the overall audit time
• Introduced a 10% reduction in audit time for manufacturers with 45 or fewer employees
• Introduced a 20% reduction in audit time for manufacturers with 15 or fewer employees
• Introduced a 20% reduction in the duration of surveillance and re-certification audits for all manufacturers
• Clarified the expectations for annual surveillance audits with the goal of reducing the audit time.

The Ombu Library, in the MDSAP aisle, has an article that explains the audit duration calculation for an MDSAP audit.

For an audit, the Auditing Organization determines the processes and audit tasks to include. MDSAP provides an Excel workbook that includes the standard time for each audit task and a place to record the included tasks. The workbook calculates the audit duration. The calculation model includes provisions for adjustments such a reduction in audit time for fewer than 45 employees or an increase in audit time to evaluate a correction or corrective action from a previous audit nonconformance.

The EU has updated the list of standards harmonized to MDD. The list, published on November 17, 2017, is available at http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices/index_en.htm

The list includes EN ISO 13485:2016 and EN ISO 13485:2016/AC:2016. The presumption of conformity to EN ISO 13485:2012 ends on March 31, 2019. Accompanying note says, “The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation”.

The Ombu Library, in the Medical Device Risk Management aisle, explains the method for documenting a Hazard Analysis using an Excel worksheet. ISO 14971:2007 (and the European variant) is a process standard that outlines a method to identify hazards and reduce the associated risks to an acceptable level. The standard requires traceability through the process. The most common approach uses an Excel workbook in which the columns represent the process steps and the rows have the analysis information for the hazard.

FDA published the 2017 version of Chapter 5 Establishment Inspections of the Inspections Operations Manual. The 127 page document provides detailed information on conducting establishment inspection, including device establishments.

It is available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-ice/documents/document/ucm150576.pdf

The Ombu Library, in the Medical Device Regulations aisle, has an article, Documenting Changes Using the 510(k) Guidance, that explains the changes in a medical device and when they trigger the threshold for a new 510(k).

A manufacturer can change a device using either a design change or a production/process change. Evaluate each change to determine if it triggers a new 510(k). If it does not, review all changes since the most recently cleared 510(k) to determine if the cumulative changes trigger a new 510(k).

FDA announced an update to eSubmitter. For device manufacturers, this free software prepares files for submission to the FDA gateway. It includes both MDRs and Correction and Removals reports.

It is not clear from the announcements what will happen to files stored in eSubmitter after updating a manufacturer implements version 3.0.0. Also, eSubmitter interfaces with software to transmit the prepared files to the gateway; the need to revise the interface is not clear.

Software Disposition Notice

The FDA has begun disposition of eSubmitter 2.x.x. The agency will be providing an updated version (3.0.0) of this software in December 2017, which will require a new installation. eSubmitter 2.x.x can continue being used until 5/7/2018, at which point it will be disabled. If you have any questions or concerns please contact the eSubmitter help desk.

The Ombu Library, in the Quality Auditing aisle, has an article on identifying EU NBs and MDSAP AOs. The article has pointers to the master list in each case.