A Good Paper on Comparison of Approaches to Regulation of Different Countries

The paper titled "Ensuring Medical Device Effectiveness and Safety: A Cross-National Comparison of Approaches to Regulation" by Kramer et al. provided a systematic and in-depth comparisons of regulation of the US, EU, Japan, and China. The comparisons are based on six key features of device regulation:

1. Regulatory Authority
2. Pre-Market Evaluation
3. Adverse Event Reporting
4. Quality System Regulation
5. Post-Approval Studies
6. Post-Market Regulation Actions

Emerging strategies of post-approval surveillance were also discussed such as unique device identifier (UDI) system.

New Final Guidance of 510(K) by the FDA

On July 28, 2014, FDA issued the newest "Final Guidance of The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" after revised draft guidance issued in Dec 28, 2011. The final guidance gives more examples than the 2011 draft guidance to better illustrate the decision-making process during a 510(k) review. It also includes a sample 510(k) summary which is more much detailed than most 510(k) summary documents found on the FDA website. Special and Abbreviated 510(k) sections were removed. FDA intends to finalize these sections separately. Although FDA states that this guidance is "not intended to implement significant policy changes," the guidance clarifies and addresses many key issues in the 510(k) program.

The US FDA requires that the manufacturers demonstrate safety and efficacy of the product, unless the devicecan be shown to be substantially equivalent (SE) to a predicate product that is legally marketed in the United States (via the 510(k)). For most new products, those without predicates, and certain high-risk products (typically Class III), a PMA is required. Certain Class I and exempted Class II medical devices are permitted to be marketed without the FDA’s prior authorization, although manufacturing(Quality System Regulations) and/or documentation controls may still apply. Some important points are summaried below:

Predicate Device

Predicate device is a the legally marketed device a legally marketed device, which is a device that (i) was legally marketed prior to May 28, 1976 (preamendments device) and for which a PMA is not required; or (ii) has been reclassified from Class III to Class II or I; or (iii) has been found SE through the 510(k) process. Although a manufacturer can identify multiple predicate devices, FDA recommends identifying a primary predicate in the submission.

Study Clinical Trials of Medical Device by FDA Bioresearch Monitoring (“BIMO”) program

FDA Bioresearch Monitoring (“BIMO”) program are to protect the rights, safety, and welfare of human research subjects and to assure the quality, reliability, and integrity of data collected. It is a good source to learn good clinical practice, responsibilities of sponsors, clinical investigators, contract research organizations, monitors, institutional review boards in clinical trials of medical devices and preparing for FDA inspections. 

FDA Launches Online National Medical Device Curriculum

FDA has launched a new learning tool for academic institutions and science and technology innovators called the National Medical Device Curriculum, to advance their understanding of FDA's medical device regulatory processes. The curriculum offers students FDA-endorsed knowledge about navigating the regulatory process, including how to design, test, and clinically evaluate devices; identify the root causes of adverse events and device malfunctions; and develop iterative device designs. The curriculum includes a series of four fictional case studies based on real-world medical device scenarios in a format similar to Harvard Business School Case Studies. 

By understanding FDA's regulatory process, innovators can accelerate the delivery of innovative medical products to patients.

FDA guidance to nanotechnology products

Nanotechnology is an emerging area which can create many new materials for medical devices, medicine, electronics and energy industries. On the other hand, more and more concerns about nanotechnology are raised about the toxicity and environmental impact of nanomaterials. 

Today, FDA issues three final guidances and one draft guidance to support the responsible development of nanotechnology products (the link).

In guidances, FDA has not established regulatory definitions of “nanotechnology,” “nanomaterial,” “nanoscale,” or other related terms. It aims to help industry when they should consider potential implications for regulatory status, safety, effectiveness, or public health impact that may arise with the application of nanotechnology in FDA-regulated products. FDA advises industry to consult with FDA early in the development process to facilitate a mutual understanding of the specific scientific and regulatory issues for their nanotechnology products.

In "Guidance for Industry Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology", FDA identifies two Points to Consider that should be used to evaluate whether FDA-regulated products involve the application of nanotechnology.

1. Whether a material or end product is engineered to have at least one external dimension, or an internal or surface structure, in the nanoscale range (approximately 1 nm to 100 nm);
2. Whether a material or end product is engineered to exhibit properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer (1,000 nm).

Japan Visting

This week we have a chance to visit the factory of a well-known Japan chemical & materials company. A ond-day visiting in Tokyo and some photos nearby the hotel:

Suica