Regulatory Support

Regulatory Affairs provides customers with Regulatory Compliance Certificates to verify that West products and processes meet regulatory agency expectations in all major markets.

Examples of compliance certification letters include:

• Direct/Indirect Food Contact Regulations
• Materials of Animal Origin (TSE/BSE Risk Evaluation for Raw Materials)
• Heavy Metals (Toxics in Packaging Legislation)
• Natural Rubber Latex/Dry Natural Rubber Content
• Additives of Concern (phthalates, nitrosamines, etc.)
• Elemental Impurities
• Conflict Minerals

Global Submission Support Packages are intended to support customers in countries where Drug Master Files (DMFs) and Master Access Files (MAFs) have not been established. They provide customers with the technical information for West products and processes needed for inclusion in their drug applications.

The content of each package is designed to meet Health Authority expectations for pharmaceutical components and delivery systems in drug applications and they are backed by West RA support for any follow-up questions you may receive from reviewing agencies. West currently has or can provide packages for the following products and processes:

• Daikyo^® Crystal Zenith^® Cartridge System
• Daikyo^® Crystal Zenith^® Syringe System
• Daikyo^® Crystal Zenith^® Vials
• NovaPure^® RS/RU Components
• Steam Sterilization Process
• Standard Elastomers
• Westar^® RS Lined Seals
• Westar^® RS Wash Process
• Westar^® RU Gamma Sterilization Process
• Westar^® RU Steam Sterilization process
• SelfDose™ Manual Injector
• SmartDose^® Platform

Evaluation of Primary Functions

The concept of primary functions was first introduced in the 2022 revision of ISO 11608, Needle-based injection systems for medical use — Requirements and test methods: Part 1. Primary functions are defined in the ISO 11608-1 standard as a “function or operation of the needle-based injection system, which, if it does not perform to specifications during use, would directly result in a failure to accurately deliver the medicinal product via the correct route and/or directly result in unacceptable harm to the patient.”

Evaluation of Essential Performance Requirements

Determination of essential performance requirements (EPRs) are a critical step in the evaluation of a drug/device combination. EPRs are generally referring to those aspects of the combination product that are critical for device performance during clinical use to achieve its intended function.

Considerations for Medical Device Delivery and Product Classification

As technology evolves to meet the needs of patients, device options are expanded to cover multiple delivery profiles and drug types. In some cases, drugs may require reformulation in order to move a therapy that is traditionally provided via a large volume infusion to something that could be provided in a handheld device or an on-body delivery system (OBDS). This process can result in a range of delivery volumes, viscosities and dose delivery profiles (time and rate).

Special 510(k) Program Pilot Overview

On October 1, 2018, the Food and Drug Administration (FDA) launched the Special 510(k) Program Pilot, which aims to expand on the types of changes eligible for the program to improve the efficiency of 510(k) review.  

Devices Proposed for a New Use with an Approved, Marketed Drug; FDA Public Hearing

Medical products are often intended and labeled for use in conjunction with other medical products marketed by different sponsors. In some cases, the medical products are of different types. Typically, the different sponsors collaborate when the two products are to be used together for a new intended use. however, sponsors seek marketing authorization from FDA for a medical product for a new use with the approved, marketed medical product of another sponsor, and the sponsor of the approved, marketed product does not wish to pursue the new use or work with the other product sponsor.  

Determining Whether to Submit an ANDA or a 505(b)(2) Application Overview

The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (Hatch-Waxman Amendments) added section 505(b)(2) and 505(j) (Abbreviated New Drug Application (ANDA) to the FD&C Act, which describe abbreviated approval pathways. With the passage of the Hatch-Waxman Amendments, the FD&C Act describes different routes for obtaining approval of two broad categories of drug applications: new drug applications (NDAs) and abbreviated new drug applications 
(ANDAs). 

China Continuous Improvements to More Efficient Regulatory Agencies

Chinese State Councilor, Wang Yong, delivered an institutional restructuring plan of the State Council at the fourth plenary meeting of the first session of the 13th National People's Congress (NPC) at the Great Hall of the People in Beijing. The draft restructuring plan is intended to make the government better-structured, more efficient, and service-oriented. 

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices FDA Guidance

Voluntary consensus standards can be a valuable resource for industry and FDA staff. The use of  consensus standards can increase predictability, streamline premarket review, provide clearer regulatory expectations, and facilitate market entry for safe and effective medical products. 

Impact of GDUFA II Fee Structure on Generic Drug Change Evaluation

GDUFA II becomes effective on October 1, 2017, bringing significant changes to the user fee structure. Some of these changes may provide incentives for generic drug manufacturers to pursue manufacturing upgrades that may have previously been prohibitive.

Human Factors Considerations in Combination Product Design and Development

Unannounced EU Medical Device Audits by Notified Bodies: Impact on Suppliers