**6. Regulation and approval/clearance of anti-obesity medical devices**

The regulation of anti-obesity medical devices varies by countries or group of countries. There are important differences in the regulatory processes, cost, and time to approval between the USA and Europe [15].

Over-the-counter anti-obesity medical devices may or may not need regulation and approval/clearance depending on the devices and countries.

#### **6.1 USA**

In the USA, the regulation of medical devices is centralized since 1976 through the FDA. This centralized process allows a better coordination and enforcement of rules. The CDRH is in charge of approval/clearance of anti-obesity medical devices. There are three regulatory classes of medical devices: Class I (low risk), Class II (moderate risk), and Class III (high risk). Based on the expected weight loss, two categories of anti-obesity medical devices have been defined: weight-loss devices ("more" weight loss) and weight-management devices ("less" weight loss). The approval/clearance is through premarket notification process [510(k)] or premarket approval (PMA) process and is based on safety and effectiveness.

A new guidance using benefit-risk approaches is in preparation by the CDRH taking into account the weight loss (extent and duration), the rate of responders (≥ 5% weight loss), the reduction of comorbidities (e.g., hypertension, dyslipidemia, type 2 diabetes), and the safety [rate and severity of adverse events (AEs)].

#### **6.2 Europe**

Since its formation in 1993, the European Union (EU), currently a group of 27 countries (after the recent removal of the United Kingdom), has established rules for the approval of medical devices. Anti-obesity medical devices are regulated under directive 93/42/EC. There are four regulatory classes of medical devices: Class I (low risk), Class IIa (low-moderate risk), Class IIb (moderate-high risk), and Class III (high risk). Each member country has a regulatory entity called Competent Authority (CA). The CA certifies/notifies entities called Notified Bodies (NBs) in each country. The NBs are private, for-profit companies responsible for conformity assessment and CE (Conformité Européenne) mark. There are over 50 NBs in the EU. The NBs contract with the manufacturers to supply the CE mark and the approval is based on safety and performance. Clinical effectiveness is not a requirement. An anti-obesity medical device with a CE mark can be marketed in any EU member country.

In the EU, the approval process is more flexible, faster, and less expensive in comparison to the USA.

#### **6.3 Other countries**

Other countries have different regulatory procedures. The approval process has varying degrees of sophistication and challenges. In Japan for example, the application is processed by the Pharmaceutical and Medical Device Agency (PMDA). Although the Japanese market is very attractive for foreign manufacturers, the approval process is complicated, long, and expensive due to multiple factors (e.g., lack of translated documents from Japanese, need to perform specific and costly studies in the Japanese population).

Several countries accept the FDA approval/clearance or the CE mark.

#### **7. Approved/cleared anti-obesity medical devices**

Several anti-obesity medical devices have been approved/cleared in the USA, in the EU, and in other countries. Some devices have been approved first in the EU before being approved several years later in the USA. This section focuses on antiobesity medical devices regulated in the USA.

Below are the anti-obesity medical devices approved/cleared in the USA (**Table 1**). Their use should always be in conjunction with lifestyle recommendations on diet and exercise.


**243**

**Figure 1.**

*Anti-Obesity Medical Devices*

**7.1 Weight-loss devices**

*7.1.1 Gastric band devices*

*7.1.1.1 Lap-Band®*

kg/m2

to device).

sity with BMI ≥ 40 kg/m<sup>2</sup>

*DOI: http://dx.doi.org/10.5772/intechopen.91697*

intake with subsequent weight loss [8].

Lap-Band® (BioEnterics Corporation) is an adjustable silicone band placed laparoscopically around the proximal stomach immediately below the gastroesophageal junction and attached to a subcutaneous reservoir (**Figure 1**). The level of pressure is adjusted by varying the amount of fluid that is inserted into the band. The technique is reversible, has low procedural risk, and can be performed in an outpatient setting. Lap-Band® can be revised and/or replaced as needed. The pressure imposed to the proximal stomach causes early satiety and a decrease in food

In the pivotal study, 292 subjects (247 females, 45 males, mean BMI = 47.4

) were implanted with Lap-Band® and had follow-up evaluations for 36 months. The primary effectiveness endpoint, assessed in the per protocol population at Month 36, was the excess weight loss. Safety analysis also included an additional seven subjects who previously received a similar device. At Month 36, the excess weight loss was 36.2%, relatively stable over the previous 18 months (the weight loss was 18.0%). AEs were observed in 266 subjects (89.0%). Most AEs were of gastrointestinal origin (mainly nausea/vomiting, gastroesophageal reflux, and abdominal pain, mild in the majority of cases). Serious AEs (SAEs) were observed in 16 subjects (5.4%), mainly port leakage and 2 deaths (unrelated

Overall, Lap-Band® is relatively safe and has a strong effectiveness. The device was approved by the FDA in June 2001. It is indicated for weight loss in severe obe-

or obesity with BMI ≥ 35 kg/m2

more severe comorbidities, in conjunction with lifestyle recommendations, in subjects who failed to respond to diet, exercise, and behavior change. It is contraindicated in several conditions including pregnancy, non-adult subjects, inflammatory diseases of the gastrointestinal tract, upper gastrointestinal bleeding conditions,

*Lap-Band® (BioEnterics Corporation—Picture downloaded from the internet).*

in the presence of one or

#### **Table 1.**

*Approved/cleared anti-obesity medical devices in the USA ranked by approval date.*
