Device approval process

Finished component tests may be divided into three categories those used as routine identity and/or quality control tests, those tests recommended or mandated by government, standards, and compendial groups, and those test that are part of the larger rubber component acceptance and drug/device approval process. In many instances, a test may fall into more than one category. 

I. NEW MEDICAL DEVICE APPROVAL PROCESS IN THE UNITED STATES... 

There are a wide variety of tests in the literature addressing these various requirements. Protocols for many of these tests have been issued as ISO standards. The American Society for Testing and Materials (ASTM) has also developed protocols for demonstrating biocompatibility. Since these standard protocols are recognized by many regulatory agencies, their use will often aid in the device approval process. 

Class III devices, unless they are substantially equivalent to a device already marketed without a PMA appHcation, require formal PDA approval through the PMA process before initial sale. The PMA process is comparable to the new dmg approval process (18). In both cases, safety and effectiveness data must be reviewed by PDA prior to marketing. An approved PMA appHcation acts like a private Hcense granted to the appHcant to market a particular device. Other firms seeking to market the same type of device for the same use must also have an approved PMA. 

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... 

The Food and Drag Administration Modernization Act to streamline the drug and device review and approval process. 

Drug approval processes go through IND and NDA procedures in Japan. The MHLW of Japan has set up the Pharmaceutical and Medical Device Agency (PMDA), which provides technical consultation services for clinical trials. There are four types of consultations before IND, at the end of Phase II studies, before NDA, and consultation on individual protocols. 

But DSHEA is very different then the standard approval process for drugs and medical devices, and emphasizes the regulatory enforcement of label claims and advertising and marketing issues rather than the efficacy and quality of the supplements themselves. Unlike new drug and medical device applications, controlled clinical trials aren t part of the supplement review process, nor is any FDA inspection of a company s manufacturing facilities or quality control systems. 

The State Institute for Drug Control is responsible for supervision in the pharmaceutical sector, medical device approval, the registration process, clinical trial approval, withdrawcil of drugs cmd medical devices, control of advertising and inspection of GMP, GLP and GCP. 

In addition to these advances, a number of device developments have focused on using the established capsule technologies. These new designs on an old theme appear to be have been successful [13], although a number have still to make it through the approval process to the marketing phase. 

The CDRH section Device Advice of the FDA s Web site provides extensive detail and guidance on the device submission and approval process. [4. http //www.fda.gov/cdrh/ devadvice/ (accessed October 2005).]... 

There is the long-standing belief that the approval process for medical devices is much faster than the IND/NDA drug method. This is certainly true for Class I, Class II, and some preenactment Class III devices—products that can be cleared through Premarket Notification or 510 (k) submissions. Such products are often approved for commercialization in 90 days or less. However, the difference in time is less apparent for manufacturers of new Class III products, where preclinical studies, clinical trials, and the premarket approval process is required. Statistics with respect to time of inception through time to market for new Class III devices are not readily available, but in the author s opinion it would be similar to that required for a new drug. 

The premarket approval process must in most cases begin with a clinical trial, and its requirements are included in the following sections on Investigational Device Exemptions. The Investigational Device Exemption/Premarket Approval process is not a trivial undertaking. It will likely take three to five years to complete (see Fig. 1). 

CDRH approves medical devices through the premarket notification and premarket approval processes. Most marketed devices are approved by the FDA via submission of a Premarket Notification or 510(k). A 510(k) notification is required for Class I devices that are not exempt from notification, all Class II devices, and certain Class III devices. A 510(k) is a premarketing submission demonstrating that the device to be marketed is substantially equivalent to, or as safe and effective as, a legally marketed device that is not subject to premarket approval. The legally marketed, comparator device is termed the predicate device. 

Regulatory oversight of products that combine a drug and a device require coordination within the FDA divisions responsible for each aspect of the product. This causes increased difficulty for the sponsor company in determining who is primarily responsible for the review of their application. The sponsor finds themselves in a position of encouraging the two Centers reviewers within the FDA to communicate and share information on their review and the status of their review. Reviews that involve coordination between FDA Review Divisions and reviewers who do not usually work together can add significant time to the FDA review and approval process. 

An NDA submitted to the MHLW is reviewed by the OPSR. OPSR personnel have the authority to inspect the drug manufacturing facility and clinical trial sites to assess compliance. Results of the review are forwarded to the Pharmaceutical and Medical Devices Evaluation Center (PMDEC), which prepares the approval procedures. The Central Pharmaceutical Affairs Council (CPAC) gives the final approval. Figure 8.10 shows the drug approval process in Japan. 

Recent legislation in the U.S.A., the Safe Medical Devices Act of 1990, has increased the range of types of devices required to go through the premarket approval process rather than the premarket notification (510k) process. This may be indicative of future FDA activity in the devices sector along the lines seen with pharmaceutical products. 

The FDA Modernization Act took the Prescription Drug User Fee Act and expanded it to improve and speed up the approval process for new drugs and devices. A fast track approval process was implemented for serious or life-threatening disease products that demonstrated the potential to address unmet medical needs. Inactive ingredient labeling requirements were implemented for... 

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