European Medical Device Regulation (MDR) - Extension of Transition Periods In Accordance with Regulations (EU) 2023/607
On 20 March 2023, Regulation (EU) 2023/607, amending Regulations (EU) 2017/745 with regards to the transitional provisions for certain medical devices, was published in the Official Journal of the European Union. No changes were made from the original proposal. The amendment immediately entered into force on its publication in the Official Journal.;
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.
Manufacturing Site Changes for Packaging Materials and How They Impact Pharmaceutical Partners
In 2021, the Center for Drug Evaluation of the NMPA issued Technical Guidelines for Pharmaceutical Changes Research for Marketed Chemicals (No. 15, 2021), which details NMPA’s expectations on management of change with existing registrations for drug preparers. Changes are assessed based on the significance of impact on drug safety, effectiveness, and quality controllability of drugs.The guideline divides changes into three categories: major changes (significant impact), medium changes (medium impact), and minor changes (small impact). Depending on the category, the report type, requirements for verification of the safety,efficacy, and stability of the drug and even the filing agency vary.
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).
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
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.
Human Factors Considerations in Combination Product Design and Development
Human factors studies plays a key role in maximizing the likelihood that the device will be safe and effective for use by the intended users and environments.
Unannounced EU Medical Device Audits by Notified Bodies: Impact on Suppliers
European medical device licensing regulations permit Notified Bodies to evaluate manufacturers and suppliers for conformance to quality standards. Suppliers identified as critical may be subject to announced and unannounced audits and must comply or risk jeopardizing the device manufacturer’s license.