FDA-Regulated Medical Device Compliance and OEM Contract Manufacturing

It’s common knowledge that medical devices sold in the US are subject to numerous regulations, most of which are imposed by the Food and Drug Administration. What’s less well-known is that the manufacturing facilities that produce these devices are also subject to FDA regulations. The agency is committed to patient safety and consistent device quality, and manufacturers must meet stringent QC criteria to register their facility with the FDA.

Therefore, medical device OEMs have much to consider when choosing a contract manufacturer (CM). Selecting a CM partner with a production environment within FDA medical device compliance mitigates the risks associated with product recalls or adverse regulatory actions and can give you a competitive edge in a crowded market. You need to know about FDA-regulated facilities and OEM contract manufacturing here.

What Makes a Facility FDA-Regulated?

Before you evaluate FDA-regulated manufacturing facilities, it’s important to know the basics — what authority the agency has, how facilities meet the criteria, and what it means for you as an OEM.

The US Congress grants the FDA significant regulatory authority over medical devices and their manufacturing via several statutes. Perhaps the most important is Title 21 of the Code of Federal Regulations (CFR), which contains the government’s Current Good Manufacturing Practices (CGMP) in a section commonly known as the Quality System Regulation (QSR). 

Among the mandates in these regulations are a robust quality system for all aspects of medical device creation and usage. This encompasses a device’s entire lifecycle — design, manufacturing, packaging, labeling, storage, and installation. The primary goal of the QSR is to ensure that medical devices are produced consistently and meet safety standards.

FDA-regulated facilities must adhere to strict requirements regarding cleanliness, record-keeping, and process controls. The CGMP and the QSR emphasize the need for design controls, process validation, corrective and preventive actions (CAPAs), and management responsibility. Medical device manufacturers that believe they meet all the requirements must register with the FDA annually between October 1 and December 31.

Ensuring Compliance in FDA-Regulated Facilities

After a facility receives approval from the FDA, the focus shifts toward ensuring and maintaining compliance. Audits and inspections are key in verifying a facility’s ongoing FDA compliance. This can take the form of external audits conducted by third-party certification organizations. In this case, a certified audit team can independently verify compliance with standards such as ISO 13485.

The FDA itself also conducts inspections of medical device manufacturing facilities. The agency will assess compliance with the QSR while reviewing the facility’s internal processes and quality management systems. FDA inspections can be routine events scheduled ahead of time or triggered by adverse events like product recalls and customer complaints.

Comprehensive documentation is critical for validating compliance, whether a standards body, the FDA, or an internal QC team performs an audit. Among the key documents to review include:

• Device Master Record (DMR): The DMR contains all necessary information for producing a specific medical device, including specifications, manufacturing processes, QC procedures, and labeling documentation.
• Corrective and Preventive Actions (CAPA) process: A manufacturer’s CAPA system should outline procedures for identifying, investigating, and resolving quality issues, along with implementing preventive actions to reduce the likelihood of future problems.
• Device History Record (DHR): Each batch or lot of medical devices should have a DHR, which documents the complete manufacturing history. Important data in the DHR includes quantities produced and any deviations from the DMR in the manufacturing process.

In addition, the FDA likes to see evidence of effective training programs to ensure all employees understand and adhere to FDA regulations and internal procedures. Training programs should cover CGMP requirements, QC procedures, documentation practices, and the CAPA process, among other critical information.

The Advantages of Partnering with FDA-Regulated CMs

Registering with the FDA and maintaining regulatory compliance are challenging tasks that require diligent training, meticulous record-keeping, and ongoing employee training. FDA-regulated contract manufacturers relieve OEMs of the regulatory burden of bringing a device to market. This translates into several advantages for OEMs who find the right CM to work with, including:

• Reduced regulatory delays and penalties risk, as the CM ensures FDA compliance for OEMs.
• Faster time-to-market for compliant devices since the OEM doesn’t have to wait for their facility to receive FDA registration.
• Enhanced trust from healthcare providers and patients means that it is safe to know that the devices meet all regulatory requirements.

Questions OEMs Should Ask About FDA-Regulated Facilities

When looking for a medical device CM, you should prioritize FDA regulation and how well the manufacturer maintains compliance. Ask these questions to get a good picture of the CM’s FDA compliance:

• How often is the facility audited? Manufacturing facilities that receive regular audits are more likely to remain FDA-compliant.
• What processes are in place to maintain FDA compliance? Pay particular attention to QC procedures, the CAPA process, and other quality concerns.
• Can you provide examples of successful FDA inspections? A CM should maintain records of all inspections and audits, so ask for proof of compliance.

Sanbor Medical: Experienced, FDA-Regulated Medical Device Manufacturing

As many medical device OEMs know, contract manufacturing has great value. A CM can help get your device to market faster while using economies of scale to save you significant money. However, you shouldn’t overlook the value of working with an FDA-regulated CM. Finding the right CM partner helps mitigate your risks, navigate medical device supply chain management, and build trust with physicians and patients.

Sanbor Medical is fully FDA-registered and has decades of experience in maintaining compliance. We implemented our first ISO quality system in 1998 when we earned ISO 9002 certification. Sanbor Medical first met ISO 13485 standards in 2005, and we are currently ISO 13485:2016 certified and QSR compliant.

To learn more about our FDA-regulated medical device CM services, contact Sanbor Medical today.