16/17 November 2021
At the end of March, the FDA announced in the Federal Register that changes to 21 CFR 860 (Medical Device Classification Procedures) were planned. Chapter 860 is divided into 3 subchapters (General, Classification, Reclassification). Based on risks, the classification includes 3 classes (class I, II, III). Class III comprises the highest risks with regard to safety and efficacy of a medical device.
According to its risk class, a medical device will be placed under different regulatory requirements. Class I products "only" have to comply with general controls which are laid down in the Food, Drug and Cosmetic Act (FD&C Act). Surgical instruments are for example typical class I products. Class II products are subject to special controls in addition to the general ones (i.e. strengthened requirements on market monitoring) Examples of class II products are infusion pumps and acupuncture needles. Class III products underlie a "premarket approval" procedure which is comparable to a marketing authorisation for Medicinal Products/Drugs. Class III products include for example pacemakers and HIV test kits. A standalone database is available for the classification of medical devices.
The changes to 21 CFR 860 are required to be able to fulfil the necessary provisions from the "Food and Drug Administration Safety and
Innovation Act (FDASIA)". Part of this legislation also aims to enhance public health protection and encourage innovations in order to faster access of products to the market. In parallel, classification into the lowest class shall also be adapted to the legal requirements.
The changes planned are very extensive and concern almost every subparagraph of 21 CFR 860. New sections should be added like 21 CFR 860.90--Consultation with Panels, and 21 CFR 860.133--Procedures When the Commissioner Initiates a Proceeding to Require Premarket Approval under 515(b) of the FD&C Act.
Conclusion: The changes planned to 21 CFR 860 (Medical Device Classification Procedures) are significantly comprehensive. The proposals can be commented until 23 June 2014.
Please click here to access the announcement about the changes to 21 CFR 860 and the respective text.