Pre-market approval

The 510(k) pre-market notification process is not as onerous as the pre-market approval procedure, as clearance to market a device is not based on actual assessment of the safety and effectiveness of the particular device in question. Instead, devices can be cleared on the basis that they are substantially equivalent to existing devices that have been recognised as safe and effective, or that they conform to specific device standards promulgated or recognised by the FDA. There are four procedural variations to the 510(k) notification process. 

This is not a common approach, as new innovative devices will tend to be viewed as Class III devices requiring pre-market approval. However, if the manufacturer can show that the level of risk does not warrant placing it in the higher risk category, he/she may petition the FDA to have it reviewed through the de novo 510(k) procedure. 

The pre-market approval process is a considerably more complex procedure, as the FDA can only grant marketing approval on the basis of an assessment of the actual safety and effectiveness of the device in question. Thus, it is similar to a drug... 

Investigational Device Exemptions - 21 CER Part 812 Pre market approval - 21 CFR Part 814... 

Part 71 Color additive petitions — These regulations describe the pre-market approval process for new color additives or new uses for listed color additives. ... 

Medical devices were first made subject to FDA regulation under the FD C Act of 1938. At that time, the statute included no requirement for premarket testing or approval. Congress enacted the Medical Device Amendments of 19766 to require pre-market notification for all medical devices, and pre-market approval for some old and new devices for which there is no adequate assurance of safety and effectiveness. The 1976 Amendments established a broad new array of statutory requirements and enforcement provisions. This new regulatory approach was supplemented by the Safe Medical Devices Act of 1990 3 and further refined by the Medical Device Amendments of 1992,61 Food and Drug Administration Modernization Act of 1997,6 jj g Medical Devise User Fee and Modernization Act... 

Compliance Policy Guide 7132c.08. Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval. FDA. http //www.fda.gov/ora/compliance ref/cpg/ cpgdrg/cpg490-100. html. 

Prior to 1976, in total contrast to the extensive testing and other pre-market approval requirements established under the FFDCA for new substances intended to be marketed as drugs, and under the FIFRA for new substances intended to be marketed as pesticides, there were no pre-market statutory requirements for new industrial chemicals to protect human health and the environment from the risks posed by such substances. In the USA, chemical manufacturers could produce and market any new industrial chemical at will and without notifying the EPA. 

US FDA, 1992, Food and Drug Administration Points to consider for the use of recycled plastics in food packaging chemistry considerations. Chemistry Review Branch, Office of Pre-market Approval, HFS-247. Washington DC, December 1992. 

Does not require pre-market approval by the FDA because it meets the regulatory definition of human cells, tissue, and cellular and tissue-based products, or HCT/Ps. 

EM Fry. The role of the inspection in pre-market approval for drug products. Paper presented at the Pharm Tech Conference, Sheraton Centre Hotel, New York, New York, September 22-24, 1981. 

To make informed choices of chemicals in order to avoid hazards. There are comparatively few chemicals for which this choice is governed by international or national restrictions on the use of individual chemical substances or by regimes for pre-market approval of pesticides and other chemicals of particular concern. 

Pre-market approval system this system was applied by some new Member States. All materials and articles had to be approved by a central authority before they could be placed on the market. This system no longer exists. 

PMA Pre-Market Approval Application (FDA) Pharmaceutical Manufacturers Association (now PhRMA) (equivalent to NDA for Class III Devices)... 

Two materials are currently available in this category, namely Activa Bioactive Restorative and Activa Bioactive Base Liner, both manufactured by the American company Pulpdent Corporation. The US Food and Drugs Administration (FDA) gave pre-market approval for these two materials in 2013 [30]. This approval was given on the grounds that these materials can be considered essentially similar to currently available resin-modified glass-ionomers. 

Two devices are commercially available. Thera-Sphere (glass microsphere MDS Nordion, Kana-ta, Canada) was approved in 1999 by the Food and Drug Administration (FDA) under a Humanitarian Device Exemption (HDE) for the treatment of unresectable hepatocellular carcinoma (HCC) in patients who can have appropriately positioned hepatic arterial catheters with or without portal vein thrombosis [1]. SIR-Spheres (resin microsphere Sirtex Medical, Lane Cove, Australia) were granted full pre-marketing approval in 2002 by the FDA for the treatment of colorectal metastases in conjunction with intra-hepatic FUDR [2]. Both devices have European approval for liver neoplasia and approvals in various Asian countries. 

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