to sustaining human life (in comparison to diagnostic or therapeutic uses)
determines its final classification.106
3. Medical Device Market Obligations
If any organization expects to successfully market a medical device in the
United States, the organization must maintain a quality system, a procedural
capability that identifies potential safety issues.107 Class II and III devices and
Class I devices automated with computer software require implementation of
design controls and process controls within such a quality system.108
Organizations also must evaluate and document suppliers on the basis of their
ability to meet quality controls, including notification to a supplier when its
product or service no longer meets quality controls.109
When an organization prepares to submit a device to the FDA for approval,
organizations may choose to pursue a Q-Submission process.110
Organizations can use this process to formally receive FDA feedback before
submitting a medical device for review in 510(k) or Pre-Market Approval
(PMA) submission.111 Q-Submission processes enable an organization to
share information about its device(s) to varying degrees, from an informal
meeting like an Informational Meeting, or a more formal Pre-Submission.112
A Pre-Submission notification submission is required when a device is
submitted for the first time or when an organization has changed or modified
aff’d in part, rev’d in part on other grounds sub nom; U.S. v. Undetermined No. of Unlabeled
Cases, 21 F.3d 1026 (10th Cir. 1994) in 28 C.J.S. Drugs and Narcotics § 26 (2016); see §§
807.81–807.100, infra note 114 (explaining that because Class III devices pose substantial
safety risk to individuals, a PMA is submitted, requiring approval from the FDA).
106. Classify Your Medical Device, supra note 103.
107. 21 C.F.R. § 820.5 (2016) (adding that a quality program involves management
responsibility for: organizational structure, policies and procedures, and training and
awareness; additionally, organizations must provide adequate resources and ensure
management review and planning of the Quality Management System (“QMS”)); see 21
C.F.R. §§ 820.20, 820.22, 820.25 (2016) (elaborating on quality system requirements
regarding management responsibilities, quality audits, and personnel).
108. 21 C.F.R. §§ 820.30, 820.70, 820.80, 820.90 (2016) (explaining that process controls
include Standard Operating Procedures (“SOPs”) and compliance with specified reference
codes or standards. Devices must also be inspected, tested, or verified prior to acceptance. If
a device is found to be nonconforming, the organization must identify and document the
nonconformance, and maintain procedures for rework).
109. 21 C.F.R. § 820.50 (2016).
110. U.S. FOOD & DRUG ADMIN., REQUESTS FOR FEEDBACK ON MEDICAL DEVICE
SUBMISSIONS: THE PRE-SUBMISSION PROGRAM AND MEETINGS WITH FOOD AND DRUG
ADMINISTRATION STAFF 9 (Feb. 18, 2014), http://www.fda.gov/downloads/medicaldevices/
111. Id. at 11.
112. Id. at 5; Kimberly Piermatteo, THE PRE-SUBMISSION PROGRAM AND MEETINGS WITH
FDA STAFF, U.S. FOOD & DRUG ADMIN. 6, http://www.fda.gov/downloads/Training/
CDRHLearn/UCM461721.pdf (last visited Oct. 9, 2016).