Archives: Inshorts

In the US and the EU, the requirements for medical device labeling are detailed and extensive and may be specific to the type of device. Manufacturers should always refer directly to the text of the applicable laws to ensure that they are following the correct procedures and staying compliant.

A label is any “display of written, printed, or graphic matter upon the immediate container of any article,” and must be clearly visible even if the “immediate container” has additional packaging. “Label” also includes anything printed on a product container or wrapper, or anything that accompanies the article when it is put up for sale. The label cannot include any false or misleading statements, and must be displayed prominently in an appropriate location

ISO 15223-1:2016

One of the important standards for marketing and this standard identifies requirements for symbols used in medical device labeling that convey information on the safe and effective use of medical devices. This standard contains all the required symbols for a medical device i.e. Reference number, Title of symbol, Description, Requirements, Informative notes, Restriction of use, Additional requirements and Registration number. Examples for commonly used labels are as follows:

Post Market Surveillance is undertaken as a responsibility of the manufacturer it is different from market surveillance which is used to describe activities to monitor compliance with the Regulations undertaken by and coordinated between national competent authorities.

1. Class I devices are typically exempt from post market surveillance requirements

2. PMS need to carry out for Class II and Class III device

3. Proactive and systematic allows cooperation on vigilance and market surveillance

4. Connects with corrective action or preventive action processes

5. Allows update of technical documentation, including the risk-benefit determination and clinical evaluation/performance evaluation

6. Part of the manufacturer’s QMS

PMS activities involves following steps:

1. Defining Post-marketing surveillance objectives

2. Surveillance planning

3. Data collection, receipt and pre-analysis

4. Analysis of surveillance data

Post PMS analysis, the results could lead to:

1. Corrective and preventive action management

2. Communication with customers to improve the device performance

3. Change in the intended use

Pre-Market Submission 510(k) must demonstrate that the device is substantially equivalent to one legally in commercial distribution in the United States: (1) before May 28, 1976; or (2) to a device that has been determined by FDA to be substantially equivalent. There are three different types of 510(k) submissions.

a. Special 510(k): This type of submission can be done to the FDA only if there is a modification to the already 510(k) cleared.

b. Abbreviated 510(k): If the FDA has recognized guidance specific to the device classification, then the manufacturer has to submit an abbreviated 510(k).

c. Traditional 510(k): If the submitter is submitting for a new device or modified device which requires more than 1 functional area of expertise

Timeline of communication during 510(k) Review:

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.

The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations (AO’s) authorized by the participating Regulatory Authorities to audit under MDSAP requirements.

The MDSAP was developed by representatives of TGA, ANVISA, HC, MHLW/PMDA, and the U.S. FDA.

Benefits of MDSAP

1. Minimize medical device manufacturer disruptions due to multiple regulatory audits

2. Provide predictable audit schedules

3. Benefit patient health and patient access with ease of entry to multiple markets

4. Leverage regulatory resources

5. Incorporate ISO 13485 assessment/requirements

6. Reduction in time, resource dealing and cost of audits with findings from multiple audits

7. Improved transparency in the industry

Software will dominate the medical device market in the near future as technology develops and becomes more and more embedded in digital platforms, where its applications in the healthcare and medical sectors are particularly prominent.

The IMDFR defined SaMD as a “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device”.

There are three types of software related to medical devices

• Software as Medical Device (SaMD)
• Software that is integral to a Medical Device
• Software used in the manufacture or maintenance of Medical Device

Examples of SaMD:

• Software that allows a mobile device to view images from an MRI, ultrasound, or X-ray that are used for diagnostic purposes
• Software that processes images which help to detect breast cancer

Classification of SaMD:
SaMD is categorized into class I to IV based on the levels of impact on the patient or public health and also the level of risk with class I represent the low risk and class IV with high risk.

General Considerations for SaMD:

IEC 62304 is a standard for life-cycle development of medical device software. The standard specifies a risk-based decision model, defines some testing requirements, and highlights three major principles that promote safety relevant to SaMD.