Premarket notification submission

The FDA will allow manufacturers to change sources of silicone elastomers (and others) if they can show that the replacement material is not substantially different from materials described in existing approved applications. The device manufacturer is still required to certify that the processes of fabrication, cure and sterilization it uses in the manufacture of its device are appropriate for the new material and that the device will perform as intended. Premarket notification submission under section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 USC 360(k) and 21 CFR 807.81(a)(3)(i), or a supplemental premarket approval application under 21 USC 360(k) section 515 and 21 CFR 814.39 is necessary when change could significantly affect the safety or effectiveness of the device. These submissions are required to be submitted and approved before the device may be marketed with the change. 

Unless otherwise exempt, a firm must submit a premarket notification, also called a 510(k), to the PDA 90 days before it intends to market a device for the first time (17). The 510(k) submission must contain sufficient information to show that the device in question is substantially equivalent to a legally marketed device for a particular intended use. This notification is also required for a product when there is a change or modification to a product that may significantly affect the safety or effectiveness of the device, or when there is a significant change or modification to the intended use of the device. 

Buehler EV (1964) A new method for detecting potential sensitizers using the guinea pig. Toxicol Appl Pharmacol 6 341 Center for Devices and Health (1999) Guidance for Industry and FDA Reviewers/Stuff Premarket notification [510(K)] Submission for Testing for Skin Sensitization to Chemicals in natural Rubber Production. U.S. Department of Health and Human Service, FDA... 

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. 

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. 

As summarized by the FDA, an investigational device exemption (IDE) allows a device to be used in a clinical study to collect safety and effectiveness data required to support a PMA application or a Premarket Notification [510(k)j submission to FDA. All clinical evaluations of investigational devices must have an approved IDE before a clinical study can be initiated. An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Eood, Drug, and Cosmetic Act that would apply to devices in commercial distribution (FDA, 2009). 

Food and Drug Administration. Guidance for Industry and FDA Reviewers Content and Format of Premarket Notification [5I0(k)] Submission Chemical Sterilants/High Level Disinfectants. Rockville, MD US Department of Health and Human Services, Food and Drug Administration, 2000. 

Standards can have a restrictive effect on new materials as well. The FDA now requires that if a company cites a standard in its premarket notification, a Form 3654 must be completed, which is intended to detail to the Agency the extent to which the standard was applied. The form can be a grueling exercise if not considered at the beginning of letting the contract for testing or if the impact it may have on the submission is not properly understood. The form must include details of any adaptation of the standard to the device under review, deviations from the standards, requirements not applicable to the device, and the name and address of the test laboratory or certification body involved in assessment of conformance to this standard. If this information is not present in the laboratory report, the applicant must provide the information as an attachment to the form for each standard cited. For many standards, completing this form has become an onerous task. Unfortunately, without this level of disclosure, it can be difficult for the FDA to understand the degree to which the biotextile conforms to the claimed standard. Because such standards citations can become product claims of performance, such detailed information is necessary. 

A sponsor may seek clearance for a device by fiHng a 510(k) premarket notification with the FDA, which demonstrates that the device is substantially equivalent to a device that has been legally marketed or was marketed before May 28,1976, the enactment date of the Medical Device amendments to the FD C act. The sponsor may not place the device into commercial distribution in the United States until the FDA issues a substantial equivalence determination notice. This notice may be issued within 90 days of submission but usually takes longer. The FDA, however, may determine that the proposed device is not substantially equivalent, or require further information such as additional test data or clinical data, or require a sponsor to modify its product labehng, before it will make a finding of substantial equivalence. 

If a device requires a submission of a Premarket notification one cannot commercially distribute the device until a letter of substantial equivalence from FDA authorizing to do so. The FDA is authorized to charge a fee for medical devices. The payment of a fee does not relate to the FDA s final decision on a submission. 

Qass n devices typically require premarket notification by submission and FDA review of a 510(k) clearance-to-market submission. A few Class II devices are exempt... 

Most Class 11 are devices required to clear premarket notification 510(k) requirements, which means the demonstration of substantial equivalence to another legally US marketed device In rare cases, clinical studies are required for a 510(k) submission. In addition, other requirements may be imposed (special controls), such as special labeUing requirements and mandatory postmarket surveillance These technologies are generally required to undergo the most formal review process for devices premarket authorization (PMA), in which a device must demonstrate safety and effectiveness through the submission of clinical studies... 

There are two primary pathways by which the FDA permits a medical device to be marketed premarket clearance by means of a 510(k) notification, or premarket approval by means of a PMA ( Premarket Approval Application ) or PDP ( Product Development Protocol ) submission. 

In the United States, most Class III and new devices that are not substantially equivalent to a legally marketed product that does not need a PM A application require clearance through the PMA or Product Development Protocol processes. Most Class II and some Class I devices require a premarket entry notification known as the 510(k), which is essentially an information package for the FDA that receives less stringent review than the PMA process. The 510(k) submission must demonstrate how the proposed medical device is substantially equivalent to a medical device that is already on the US market. Most Class I and some Class II (low-risk) devices are exempt from 510(k) submission before sale, but are stiU subject to general control requirements. 

In contrast with the European Union, where the premarketing scheme requires the submission of base sets of test data in relation to the production volumes of the new chemicals, the TSCA does not require that submitters conduct testing prior to the submission of the notification to the EPA, Under... 

---