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Author is an expert in Medical Device Regulations.

FDA Pre Submission For 510k


What is FDA 510k Pre Submission A FDA Pre Submission is a formal written request from a submitter for feedback from FDA that is provided in the form of either formal written response or, if the submitter chooses, formal written feedback followed by a meeting. Such a Pre Submission meeting can be in-person or by teleconference as the submitter prefers. A FDA Pre Submission provides the opportunity for a submitter to obtain FDA feedback prior to an intended premarket submission (i.e., IDE, PMA, HDE, De Novo request, 510(k), Dual, BLA, IND), In FDA Pre Submission face-to-face or teleconference meeting with [...]

FDA Pre Submission For 510k2023-02-01T10:29:24+00:00



Biocompatibility of Medical Devices Biocompatibility testing is a critical part of the regulatory approval process for medical devices as even the best-designed products could produce unintended complications if the materials used, cause a biological reaction in the patient. An integral part of biological risk assessment, biocompatibility testing assesses the compatibility of medical devices with the biological system. It studies the interaction between the device and the various types of living tissues and cells that are exposed to the device when it comes into contact with patients. Almost all medical devices that come in contact with human tissue require biocompatibility [...]


Quality in 510(k) Review Program Pilot


Quality in 510(k) Review Program Pilot Quality in 510k  review program pilot (RPP) gives an different method to submit a 510k to the FDA via the eSubmitter software. ( For specific device types) On April 26, 2021, the FDA announced the decision to conclude the Quality in 510(k) Review Program Pilot. Quality in 510(k) Review Files will no longer be accepted by the FDA after May 30, 2021. The applicable medical device codes for this programme were also published by FDA. The Quality in 510(k) Review Program pilot's goal is to assess the program's effectiveness and determine whether using [...]

Quality in 510(k) Review Program Pilot2022-07-30T14:30:16+00:00

Medical Device Reporting (MDR)


Medical Device Reporting (MDR) Medical Device Reporting (MDR) is one of the Postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. Mandatory reporters are manufacturers, device user facilities, and importers. Hence Mandatory reporters are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices. The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA. Manufacturers: Manufacturers [...]

Medical Device Reporting (MDR)2022-07-30T10:48:39+00:00

Software Verification and Validation


Software Verification and Validation Software validation is a requirement of the Quality System regulation. Validation requirements apply to software used as components in medical devices, to software that is itself a medical device, and to software used in the production of the device or in the implementation of the device manufacturer's quality system. Software is frequently purchased off-the-shelf for a particular intended use so, it should have documented requirements that fully define its intended use, to show that the software is validated for its intended use. Device manufacturers may use the same procedures and records for compliance with quality [...]

Software Verification and Validation2022-07-30T09:41:40+00:00

Medical Device Labelling in 510k


Medical Device Labelling in 510k Medical Device Labelling in 510k : Label is display of written, printed, or graphic matter upon the container of any article/medical device, it includes details like instructions for proper use, requirements for operating device safely, storage and maintenance and installation requirements, it also includes information that when particular medical device is put up for sale in the market. It must be clearly visible even if they contain is having any additional packaging. Medical labelling must follow instructions listed on FDA CFR 21 Part 801. No false information should be displayed on label. In addition [...]

Medical Device Labelling in 510k2022-07-02T10:28:39+00:00

Medical Device Shelf life


Medical Device Shelf life Shelf-life is the length of time you can expect a product to look and act as expected and to stay safe for use. This length of time varies, depending on the type of product, how it is used, and how it is stored. Medical devices containing highly sophisticated electronics that are lasting longer than before, raising the bar for safety and liability. The concept of shelf-life/expiration date was created to help consumers realize when a product should be discarded. Expiration date of the medical device states the termination of shelf life. After expiration date medical device may no [...]

Medical Device Shelf life2022-06-11T09:35:53+00:00

Medical Device Sterilization


Medical Device Sterilization Most surgical and medical devices used in healthcare facilities are made of materials that are heat stable and therefore undergo heat, primarily steam, sterilization. Medical devices that have contact with sterile body tissues or fluids are considered critical items. These items should be sterile when used because any microbial contamination could result in disease transmission. Such items include surgical instruments, biopsy forceps, and implanted medical devices. Sterilization is a process that effectively destroy all microorganisms from the surface of an article or in a fluid to prevent disease transmission associated with the use of that item. [...]

Medical Device Sterilization2022-06-10T18:22:51+00:00

Literature Search and Review Protocol


Literature Search and Review Protocol Clinical Evaluation Report with incomplete documentation of the literature search and review will lead to a non-conformity. Because the MDCG document 2020-13 specifically requires notified bodies to verify the literature search documentation, this can result in unnecessary questions or even audit variations. A search methodology is used to carry out a literature search and review protocol and other data retrieval. The search protocol documents the planning of the search forward to its execution. The process for literature search and review is stated in Appendix A5 of the MEDDEV 2.7/1 guidance. Importance of Developing a [...]

Literature Search and Review Protocol2022-05-13T04:14:11+00:00

EU 2017/745 and PMS


EU 2017/745 and Post Market Surveillance EU 2017/745 Post Market Surveillance (PMS) is one of the essential requirements for EU MDR (2017/745) compliance. It refers to monitoring the Medical device after it is introduced into the market and used by public members. Though the conformity of the device to general safety and performance requirements is demonstrated during the premarket phase, at that time it is not always possible to gather all the data related to the safety and performance as some rare complications and risks manifest with the widespread and long term(regular) use of the device. To detect these [...]

EU 2017/745 and PMS2021-11-16T11:07:29+00:00


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