FDA Finalizes Guidance on Postmarket Device Surveillance

The Food and Drug Administration (FDA) has finalized the guidance Friday (five years after the draft guidance was released) for device manufacturers in their interpretation of the law with regard to post-marketing surveillance of some devices class II or class III.

The guide is presented as the Office of the Government Accountability Office (GAO) said last October that 90% of post-marketing FDA studies have ordered in the past seven years were classified as inactive, although some of these studies, they have added other ongoing studies.

More recently, the FDA sent a warning letter to Argo Medical Technologies, based in Israel after its failure to carry out such monitoring studies after marketing your device to help people with spinal injuries spinal.

Background:

The Federal Food, Drug and Cosmetic (FD & C Act) gives the FDA the authority to require manufacturers to conduct a post-marketing devices of a certain class II or Class III monitoring, although the FDA says -Marketing that subsequent monitoring is not a substitute for obtaining necessary information before marketing to support 510 (k), PMA, HDE, PDP or approval, or to grant the order de novo.

In addition, the Act Food and Drug Administration Safety and Innovation (FDASIA) further clarified that the agency can issue a post-market prescription at the time of the approval of the device or at any time thereafter surveillance. Under what is called a "522 order" FDA may appeal to companies to carry out such studies postmarketing surveillance.

The order requires the manufacturer 522 begins subsequent marketing surveillance within 15 months after the date on which the order was issued.

Once comments on the draft guidance include AdvaMed industrial group criticizes the vagueness of the project, while Johnson & Johnson sought more information on the types of devices that will not be subject to such surveillance studies.

New Address:

According to the FDA, the guide is designed to help manufacturers of devices subject to section 522 orders post-marketing surveillance, providing:

•  An overview of the section of the law that allows the FDA to require such studies;
•  Information on how to order complete 522 obligations; Y
•  Recommendations on the format, content and review of post-marketing monitoring plans presentations.

In general, management, said the law allows the FDA to order "prospective post-marketing surveillance for a period of 36 months unless the manufacturer and the FDA agreed to extend this period or if there is no agreement, after completion of the differences. "

However, the law also authorizes the FDA to require a period of prospective follow-up of more than 36 months compared with a device that has an important use in the pediatric population, although the FDA said that in these cases the intention to work with the manufacturer to determine the time of placing a pediatric study.

The FDA also provides examples of situations that may arise subsequent to marketing issues, including:

•  Where the FDA to better understand the nature, severity or frequency of suspected problems identified in reports of adverse events or in the published literature.
•  For more information on device performance in clinical practice in the real world.
•  For the treatment issues or long-term safety and efficiency with rare implants and others who have contributed premarketing testing of more limited information. "For example, prior to marketing a device evaluation may have been based on indirect markers. Once the device is actually marketed, post-marketing surveillance may be appropriate to evaluate the effectiveness of the detection device or treatment the disease or condition, rather than the surrogate mother. data collected by the post-marketing surveillance can include failure rates or failure of a device for use incidents long term or resulting latent effects of use of the device "says the FDA.
• To better define the relationship between the problems and the devices when serious adverse events unexpected and inexplicable occur after a device is marketed, if there is a change in the nature of the serious adverse events (eg gravity) or if there an increase in the incidence of serious adverse events.

Upon issuance of an order 522, manufacturers must also submit a progress report every six months during the first two years of surveillance and every post provisional marketing, from the date of approval of the monitoring plan or year other date agreed separation, says the FDA.

Monitoring plans:

The FDA also states that follow evaluate all proposed plans to determine whether they will lead to obtaining useful data to answer questions surveillance or security.

Consequently, the FDA may issue a decision following letters:

1. Charter is not acceptable, that is when a submission is considered administratively complete (CDRH provides a checklist to determine if a request is administratively complete in the address).

2. Approval Letter

3. Minor Deficiency letter, citing small specific deficiencies that must be addressed by a plan to be approved;

4. Major Deficiency Letter, which would include serious deficiencies to be addressed;

5. Letter disagreement, which means that the FDA has determined that it is unlikely that the monitoring plan will result in obtaining useful data to answer questions post marketing. This letter also directs the manufacturer to provide a new declaration to answer questions post marketing.

"If the manufacturer does not agree with the FDA on the content of the plan or if the plan is rejected, describes the options for an appeal" in the law, the FDA said, noting that these include requesting a meeting with the Director the Office of the Office of surveillance and bio-metrics FDA requesting an internal review of the decision of the FDA 21 CFR 10.75, for an informal hearing, or to request a review by the Panel of medical Devices Advisory solution Committee dispute medical devices.

If a manufacturer does not meet the requirements for plan approval of post marketing surveillance and begin post-marketing surveillance in the 15 months following that order of 522, the agency said that inaction can result legal action